U.S. label recordBone

Abaloparatide

Related names in cited records: Tymlos

A parathyroid hormone-related peptide analogue. This profile cites a U.S. label record.

Citation markers ↗ open the public records supporting the adjacent statements.

Correction · September 15, 2026

We refreshed this profile's label citation to the reviewed SPL version 19, published 2026-08-17. Earlier profile versions retain their original label citations. The product-specific label account identifies its reviewed scope. 1

This version supersedes public version 2.

Start here

The evidence at a glance

What is its status in the cited records?

U.S. label record. The cited DailyMed label identifies Abaloparatide and contains the product's official indications and warnings. This profile links to the label without restating it as medical guidance.

Status sources checked through September 15, 2026. See status sources and coverage →

What do the reviewed human studies say?

Human evidence reviewed September 14, 2026 · Review version 1.

Review source snapshots checked September 14, 2026 · Integrity checked September 14, 2026.

Three selected primary reports in osteoporosis: ACTIVE, its ACTIVExtend follow-up, and ATOM. The extension follows participants from ACTIVE rather than providing an independent replication.

What the reviewed sources report

ACTIVE reported fewer new vertebral and nonvertebral fractures with abaloparatide than placebo in postmenopausal women. Its extension studied subsequent alendronate in both groups. ATOM reported greater bone-density gains in men; that endpoint does not by itself establish fracture reduction in men.

What remains unresolved?

  • How do fracture outcomes and harms compare with other treatments over longer follow-up and in populations outside these selected trials?
  • Does the bone-density improvement observed in ATOM translate into fewer fractures in men?

Read study designs, results, limitations, and sources →

What does the U.S. product label say?

Tymlos · Read September 15, 2026 · Preserved label summary 1

Which population and use does the label cover?

The cited label covers postmenopausal women with osteoporosis at high fracture risk or failure or intolerance of other available osteoporosis therapies. For men in the corresponding osteoporosis population, its indication is to increase bone density; that wording differs from the fracture-reduction account for women. Label: 1 ↗

Which safety limits matter?

The label contraindicates severe hypersensitivity, including reported anaphylaxis and angioedema. Warnings also address osteosarcoma risk, orthostatic hypotension, high blood calcium and urinary calcium or stones. The rodent osteosarcoma finding does not establish that Tymlos causes osteosarcoma in humans. Label: 4, 5 ↗

Label edition and source pins

U.S. product labeling hosted by the National Library of Medicine. This account concerns this product and label edition; other formulations and jurisdictions require their own records.

TYMLOS (abaloparatide) injection, solution · SPL version 19 · published 2026-08-17

Label ZIP SHA-256: 0972d261dcba3ae48d54920e976a32e45e2f7b9f8c2f3458dd827ca900db9c44. Extracted XML SHA-256: 4ac5a2ba440d0e916a9741978deee40d0ba4d42f291d6e40d1d113dae70b533f.

Open versioned label context data →

Reviews summarize selected studies; their scope and limitations are shown above.

Inside the official reviews

Reviewed 2026-09-16 · Preserved version 1

Why do official accounts report different fracture results?

EMA’s 2022 assessment excluded two ACTIVE sites after good-clinical-practice findings, reducing the analysis population from 2,463 to 2,070. Vertebral-fracture benefit remained, but nonvertebral-fracture efficacy was not statistically established in that subset. The older FDA clinical review reported a nonvertebral-fracture reduction. These accounts use different analysis contexts; their estimates should not be pooled as independent trials. EMA PDF pp. 180, 181, 182 ↗FDA PDF pp. 17 ↗

More findings, study links and document coverage

What did EMA conclude, and what remained uncertain?

The 2022 CHMP assessment supported authorization for postmenopausal osteoporosis at increased fracture risk after considering the total evidence. It retained cardiovascular uncertainty in vulnerable patients and requested an EU safety study. The reviewed report does not establish today’s completion status of that study. EMA PDF pp. 188, 189, 190 ↗

Which studies overlap?

ACTIVE (BA058-05-003) and its extension BA058-05-005 are a study family. The extension followed prior participants receiving alendronate; it was not an independent replication of the original randomized trial. EMA PDF pp. 180, 181 ↗

Read the separate U.S. label account → Label version and indication scope are preserved there; these agency reviews describe their own dated evidence.

Matched study identities

Protocol identifiers were matched to ClinicalTrials.gov records. This does not count extensions as new independent trials.

Document coverage

Selected sections read in 2 of 10 inventoried documents; 7 not yet reviewed; 1 unavailable. Reading selected sections does not establish complete appraisal of a document.

English PDF entries containing Eladynos in the title in the retained September 15 EMA document-feed snapshot, plus selected FDA approval-package documents. Includes candidate associations, not a complete FDA inventory, national authorizations or worldwide coverage. Live EMA page requests returned HTTP 429 on September 16; fresh page reconciliation is pending. EMA inventory source ↗

Inspect documents, application identities and source pins

Page references use one-based PDF file pages, which can differ from printed page numbers. Candidate feed associations are not verified application identities.

  • Eladynos : EPAR - Public assessment report ↗

    Selected sections reviewed · ema-57153 · Document/feed date: 2022-12-22

    Resolved feed conflict: the PDF identifies EMEA/H/C/005928/0000 on page 1; the feed incorrectly associates this document with the older EMEA/H/C/004157 application. The older refusal remains separate.

    Verified: Eladynos · EMEA/H/C/005928 · Document dated 2022-10-13. Identity checked on PDF pp. 1.

    Identity and procedure history; benefit-risk discussion, evidence limitations and recommendations, pages 180–190. Other sections have not been appraised.

    Retrieved 2026-09-15. Read PDF pages: 1, 2, 3, 4, 8, 9, 10, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190 of 191. SHA-256: cdf20ac8d4283bcbad09a4199babba6e781914feddc05cd40ea20e587759c3f7.

    Feed-listed application (not a verified association): EMEA/H/C/004157.

  • Tymlos: FDA clinical review (2016; 2017 approval package) ↗

    Selected sections reviewed · fda-abaloparatide-fda-2017 · Document/feed date: 2016-12-08

    Historical approval-package review; later labels and postmarketing outcomes require separate reconciliation.

    Verified: Tymlos · NDA 208743 · Document dated 2016-12-08. Identity checked on PDF pp. 1, 2.

    Selected identity, benefit-risk, clinical evidence and limitations sections; not a complete dossier appraisal.

    Retrieved 2026-09-16. Read PDF pages: 1, 2, 3, 4, 5, 17, 35, 126, 127 of 190. SHA-256: bf0cbf94a3346e43b2ce494a874baaff0dd57e918f09718955142b8266ea9287.

  • Eladynos : EPAR - Refusal public assessment report ↗

    Not yet reviewed · ema-43729 · Document/feed date: 2019-02-14

    Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.

    Feed-listed application (not a verified association): EMEA/H/C/004157.

  • CHMP summary of positive opinion for Eladynos ↗

    Not yet reviewed · ema-56405 · Document/feed date: 2022-10-13

    Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.

  • Eladynos : EPAR - Medicine overview ↗

    Not yet reviewed · ema-57149 · Document/feed date: 2022-12-22

    Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.

    Feed-listed application (not a verified association): EMEA/H/C/004157.

  • Questions and answers on refusal of the marketing authorisation for Eladynos (abaloparatide) ↗

    Not yet reviewed · ema-21920 · Document/feed date: 2018-07-27

    Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.

  • Eladynos : EPAR - All authorised presentations ↗

    Not yet reviewed · ema-57152 · Document/feed date: 2023-12-06

    Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.

    Feed-listed application (not a verified association): EMEA/H/C/004157.

  • Eladynos : EPAR - Procedural steps taken and scientific information after authorisation ↗

    Not yet reviewed · ema-58737 · Document/feed date: 2024-04-12

    Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.

    Feed-listed application (not a verified association): EMEA/H/C/004157.

  • Eladynos : EPAR - Risk-management-plan ↗

    Not yet reviewed · ema-57150 · Document/feed date: 2022-12-22

    Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.

    Feed-listed application (not a verified association): EMEA/H/C/004157.

  • Eladynos: EPAR - Product information ↗

    Unavailable · ema-57151 · Document/feed date: 2024-04-12

    PDF retrieval through the web reader returned HTTP 429 on September 16 after a backoff. No payload or internal application identity was verified; the older application number in the feed remains unconfirmed for this document.

    Feed-listed application (not a verified association): EMEA/H/C/004157.

Remaining work

  • Review the remaining EMA assessment, product-information, risk-management and change documents; reconcile historical applications separately.
  • Reconcile later FDA supplements and current postmarketing-study status. Earlier review conclusions are dated evidence, not a current approval-status substitute.
  • Complete full-text and correction appraisal of the related literature. Registry identity matching does not establish that all posted results or historical registry versions have been reviewed.

Open versioned document coverage and study pins →

European medicine records · 2 products or applications

EMA medicine metadata checked 2026-09-15. These are product-specific centralized records; national European authorizations and full product-information assessments require separate coverage.

Application withdrawal and refusal are distinct from marketing authorization. A withdrawal status alone does not establish why it occurred. These metadata entries do not substitute for indication, population or safety details in the relevant product information.

Open versioned records and source-feed pins →

Research coverage and study families

Search and screening record checked 2026-09-15. Counts describe records, not independent trials. Full-text appraisal is separate from an abstract review.

Open machine-readable coverage and record decisions →

PubMed search

Catalog-name and calibrated alias discovery for human evidence review. Complete query retrieval is separate from clinical eligibility, study-family linkage and appraisal.

396 retrieved · 3 included · 0 excluded · 393 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

"Abaloparatide"[Title/Abstract] OR "Tymlos"[Title/Abstract]

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:09:27.374830+00:00 · HTTP 200 · SHA-256 e2261ca30b99d1ac6fa05b130bca12e5678ab65f9361aefe480c70feed1c5f88.

  • Retrieved IDs completely represent this query response, not all relevant literature. Additional aliases, references and non-PubMed sources require separate searches.
  • Unscreened records may include animal or cell experiments, reviews, secondary analyses, mixtures, protocols and unrelated name matches.
  • Study-family mappings use available declared registry IDs; unresolved mappings do not create independent trial counts. Full-text, corrections and registry comparison remain separate work.
  • The 2017 ACTIVE correction has been read and compared with selected review v1. Corrected figure data, the supplement and full statistical appraisal remain open; this is partial reconciliation.

Showing 25 of 396 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. PubMed 36190391 — include: Selected published human report; abstract reviewed. Full-text and study-family appraisal remain separate. Study families: abaloparatide-PMID36190391-registry-linkage-unresolved.
    Bibliographic record recheck · 2026-09-15

    The selected PubMed XML payload matches the previous reviewed snapshot. This is a metadata recheck, not a new appraisal or a finding that no corrections exist. Open PubMed record ↗

    SHA-256 505bd0197b0a42beff4ed79f51ab0a025b1ebdbd3d2dbf8fcdb7b354e1d0e75b.

  2. PubMed 29800372 — include: Selected published human report; abstract reviewed. Full-text and study-family appraisal remain separate. Study families: NCT01657162.
    Bibliographic record recheck · 2026-09-15

    The selected PubMed XML payload matches the previous reviewed snapshot. This is a metadata recheck, not a new appraisal or a finding that no corrections exist. Open PubMed record ↗

    SHA-256 b734d5e42a384c3774541918b8e649c1ab725359b2d6aafc379a26cce8c15821.

  3. PubMed 27533157 — include: Selected published human report; abstract reviewed. Full-text and study-family appraisal remain separate. Study families: NCT01343004.
    Bibliographic record recheck · 2026-09-15

    The selected PubMed XML payload matches the previous reviewed snapshot. This is a metadata recheck, not a new appraisal or a finding that no corrections exist. Open PubMed record ↗

    SHA-256 6fc7a37a1f322b6c338bee074d13439ac49ee0e29213e49113bfcb18f82092c2.

    • PubMed links an erratum: Incorrect Figures. ↗.

      The correction extends Figure 3C time-to-event markers that ended one month early and clarifies that the supplement eFigure 2 legend describes a geometric mean of ratios. The publisher says the article was corrected online. Read the correction ↗

      Compared with the selected Human Evidence Review version 1: it does not reproduce Figure 3C or the eFigure 2 measurements. This check does not establish that every study result is unaffected.

      Still unresolved: The corrected figure data, supplement and full statistical analysis still require independent reconciliation before a complete study appraisal.

      Read 2026-09-15 · Correction: Incorrect Figures, January 24/31, 2017.

      Notice XML SHA-256 8e3150fa3439f119ece5d2a11c75a73f5ed25e46359fbbf186928e3f95f570e1.

  4. PubMed 42671953 — not screened: Name-query match awaiting clinical eligibility screening.
  5. PubMed 42652552 — not screened: Name-query match awaiting clinical eligibility screening.
  6. PubMed 42648994 — not screened: Name-query match awaiting clinical eligibility screening.
  7. PubMed 42618812 — not screened: Name-query match awaiting clinical eligibility screening.
  8. PubMed 42577358 — not screened: Name-query match awaiting clinical eligibility screening.
  9. PubMed 42535103 — not screened: Name-query match awaiting clinical eligibility screening.
  10. PubMed 42532988 — not screened: Name-query match awaiting clinical eligibility screening.
  11. PubMed 42503281 — not screened: Name-query match awaiting clinical eligibility screening.
  12. PubMed 42498818 — not screened: Name-query match awaiting clinical eligibility screening.
  13. PubMed 42494964 — not screened: Name-query match awaiting clinical eligibility screening.
  14. PubMed 42494861 — not screened: Name-query match awaiting clinical eligibility screening.
  15. PubMed 42464584 — not screened: Name-query match awaiting clinical eligibility screening.
  16. PubMed 42461643 — not screened: Name-query match awaiting clinical eligibility screening.
  17. PubMed 42420311 — not screened: Name-query match awaiting clinical eligibility screening.
  18. PubMed 42418005 — not screened: Name-query match awaiting clinical eligibility screening.
  19. PubMed 42351259 — not screened: Name-query match awaiting clinical eligibility screening.
  20. PubMed 42303774 — not screened: Name-query match awaiting clinical eligibility screening.
  21. PubMed 42298929 — not screened: Name-query match awaiting clinical eligibility screening.
  22. PubMed 42268882 — not screened: Name-query match awaiting clinical eligibility screening.
  23. PubMed 42181204 — not screened: Name-query match awaiting clinical eligibility screening.
  24. PubMed 42075559 — not screened: Name-query match awaiting clinical eligibility screening.
  25. PubMed 42033613 — not screened: Name-query match awaiting clinical eligibility screening.

FDA search

Active-ingredient name query in openFDA Drugs@FDA. Returned application identities include salt forms and combination products; exact indications, approval conditions, supplements and marketing status require document-level review.

1 retrieved · 1 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

products.active_ingredients.name:"ABALOPARATIDE"

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:10:08.893157+00:00 · HTTP 200 · SHA-256 2734154f18dff4533ada18d70665d915da0e41bc5ee29aba5bbca5cf9ade4b99.

  • Zero results describe this query response only, not absence of FDA approval or worldwide nonapproval.
  • This endpoint does not inventory every label, advisory proceeding, safety communication or regulatory document. Application inclusion does not establish current marketing or approval of every use.

Showing 1 of 1 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. FDA NDA208743 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: ABALOPARATIDE.

EMA search

Local matching in the pinned EMA medicines feed; document matches also use identified EMA product numbers. This is not every national European record.

2 retrieved · 2 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

Case-insensitive word-boundary identity terms: ["Abaloparatide", "Tymlos"]

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T08:34:22.905972+00:00 · HTTP 200 · SHA-256 a947c2b8a56ac2b92ec96156843f262f5e516f83b375d6791d67a8f6dc695729.

  • Document appraisal and national European sources remain open.
  • Zero matches apply only to these feed fields and terms; orphan designation is not approval.

Showing 2 of 2 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. EMA EMEA/H/C/005928 — include: EMA feed product Eladynos; reported status: Authorised. Exact indication and decision documents remain unappraised.
  2. EMA EMEA/H/C/004157 — include: EMA feed product Eladynos; reported status: Refused. Exact indication and decision documents remain unappraised.

EMA search

Local matching in the pinned EMA documents feed; document matches also use identified EMA product numbers. This is not every national European record.

10 retrieved · 7 included · 0 excluded · 3 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

Case-insensitive word-boundary identity terms: ["Abaloparatide", "Tymlos"]

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T08:34:29.167460+00:00 · HTTP 200 · SHA-256 c0c68d7d77783e0355cbc75bdd04772e9acc163236fc68abcd794477c4c3d439.

  • Document appraisal and national European sources remain open.
  • Zero matches apply only to these feed fields and terms; orphan designation is not approval.

Showing 10 of 10 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. EMA 43729 — include: Document linked by EMA product number; content unappraised. Eladynos : EPAR - Refusal public assessment report
  2. EMA 57149 — include: Document linked by EMA product number; content unappraised. Eladynos : EPAR - Medicine overview
  3. EMA 57153 — include: Document linked by EMA product number; content unappraised. Eladynos : EPAR - Public assessment report
  4. EMA 57152 — include: Document linked by EMA product number; content unappraised. Eladynos : EPAR - All authorised presentations
  5. EMA 58737 — include: Document linked by EMA product number; content unappraised. Eladynos : EPAR - Procedural steps taken and scientific information after authorisation
  6. EMA 57150 — include: Document linked by EMA product number; content unappraised. Eladynos : EPAR - Risk-management-plan
  7. EMA 57151 — include: Document linked by EMA product number; content unappraised. Eladynos: EPAR - Product information
  8. EMA 16434 — not screened: Title-name match awaiting identity and document review. Public summary of the evaluation of a proposed product-specific waiver: Abaloparatide for treatment of osteoporosis
  9. EMA 21920 — not screened: Title-name match awaiting identity and document review. Questions and answers on refusal of the marketing authorisation for Eladynos (abaloparatide)
  10. EMA 18806 — not screened: Title-name match awaiting identity and document review. P/0307/2014: EMA decision of 24 November 2014 on the granting of a product specific waiver for abaloparatide (EMEA-001667-PIP01-14)

EMA search

Local matching in the pinned EMA orphans feed; document matches also use identified EMA product numbers. This is not every national European record.

0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

Case-insensitive word-boundary identity terms: ["Abaloparatide", "Tymlos"]

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T08:34:31.262344+00:00 · HTTP 200 · SHA-256 7448bf4e77e3345b3f3fbb7062c335d2302d8ea458a246bbe8256ce48aad2806.

  • Document appraisal and national European sources remain open.
  • Zero matches apply only to these feed fields and terms; orphan designation is not approval.

Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

    ClinicalTrials.gov search

    ClinicalTrials.gov name/alias discovery, including cited product names. Matches may concern combinations, background references or different formulations; identity and outcomes need screening.

    26 retrieved · 0 included · 0 excluded · 26 awaiting a decision · 0 full-text appraisals

    Search terms, record decisions and remaining work

    "Abaloparatide" OR "Tymlos" OR "Eladynos"

    Source retrievals and payload pins
    • Open the source endpoint ↗

      Retrieved 2026-09-15T11:24:15.548791+00:00 · HTTP 200 · SHA-256 fddf848e8b1a7de7ca4e4d9674fb99a069ac3146aae0d1604aad6e3c8a2f49a4.

    • Registration is not evidence that a study succeeded, that results were published, or that a use is approved.
    • Other registries, unregistered studies and additional aliases remain outside this query.

    Showing 25 of 26 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

    1. ClinicalTrials.gov NCT03623633 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    2. ClinicalTrials.gov NCT04663464 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    3. ClinicalTrials.gov NCT03512262 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    4. ClinicalTrials.gov NCT01343004 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    5. ClinicalTrials.gov NCT00542425 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    6. ClinicalTrials.gov NCT04760782 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    7. ClinicalTrials.gov NCT04974723 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    8. ClinicalTrials.gov NCT03708926 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    9. ClinicalTrials.gov NCT07616401 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    10. ClinicalTrials.gov NCT04167163 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    11. ClinicalTrials.gov NCT04626141 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    12. ClinicalTrials.gov NCT06154187 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    13. ClinicalTrials.gov NCT03746041 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    14. ClinicalTrials.gov NCT04366726 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    15. ClinicalTrials.gov NCT06164795 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    16. ClinicalTrials.gov NCT07587775 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    17. ClinicalTrials.gov NCT06753864 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    18. ClinicalTrials.gov NCT04064411 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    19. ClinicalTrials.gov NCT01657162 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    20. ClinicalTrials.gov NCT06898060 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    21. ClinicalTrials.gov NCT04249232 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    22. ClinicalTrials.gov NCT04936984 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    23. ClinicalTrials.gov NCT03841058 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    24. ClinicalTrials.gov NCT03710889 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    25. ClinicalTrials.gov NCT04467983 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    Read the full Human Evidence Review

    Supervised synthesis

    What do selected human studies report about Abaloparatide?

    Manually reviewed September 14, 2026 · version 1

    Browse all Human Evidence Reviews · Open preserved synthesis version 1 →

    Three selected primary reports in osteoporosis: ACTIVE, its ACTIVExtend follow-up, and ATOM. The extension follows participants from ACTIVE rather than providing an independent replication.123

    Bottom line from this bounded source set

    ACTIVE reported fewer new vertebral and nonvertebral fractures with abaloparatide than placebo in postmenopausal women. Its extension studied subsequent alendronate in both groups. ATOM reported greater bone-density gains in men; that endpoint does not by itself establish fracture reduction in men.123

    Reviewed study record

    ACTIVE: fracture outcomes in postmenopausal women

    Design

    An 18-month randomized Phase 3 trial compared blinded abaloparatide and placebo groups, with an additional open-label teriparatide group.1

    Population

    The trial enrolled 2,463 postmenopausal women with osteoporosis; 1,901 completed the study.1

    Outcomes reported

    The authors reported fewer new vertebral and nonvertebral fractures and greater bone-density gains with abaloparatide than placebo. Reported hypercalcemia occurred in 3.4% with abaloparatide and 6.4% with teriparatide.1

    Limitations

    Follow-up was limited to 18 months and the teriparatide comparison was open-label. These results do not establish outcomes in men or all osteoporosis populations. PubMed links a 2017 erratum to this report.1

    Reviewed study record

    ACTIVExtend: follow-up of ACTIVE participants

    Design

    An extension followed eligible ACTIVE completers, with both groups subsequently receiving alendronate. It did not randomly assign a new independent cohort.2

    Population

    The extension enrolled 558 women from the former abaloparatide group and 581 from the former placebo group.2

    Outcomes reported

    Across the integrated 43-month period, the authors reported new radiographic vertebral fractures in 0.9% of evaluable women in the abaloparatide/alendronate group versus 5.6% in the placebo/alendronate group.2

    Limitations

    The findings describe a treatment sequence among participants who entered the extension. They cannot isolate ongoing abaloparatide effects or establish outcomes after stopping all treatment.2

    Reviewed study record

    ATOM: bone-density outcomes in men

    Design

    A 12-month randomized placebo-controlled trial used change in lumbar-spine bone mineral density as its primary endpoint.3

    Population

    A total of 228 men with osteoporosis were randomized: 149 to abaloparatide and 79 to placebo.3

    Outcomes reported

    Reported lumbar-spine bone-density gains were 8.48% with abaloparatide versus 1.17% with placebo. Common reported adverse events included injection-site reactions and dizziness.3

    Limitations

    Bone density was the primary endpoint; the reported gains should not be presented as demonstrated fracture reduction. The sample and duration limit conclusions about uncommon or longer-term harms.3

    Reviewed source set

    1. PubMed · 27533157Effect of Abaloparatide vs Placebo on New Vertebral Fractures in Postmenopausal Women With Osteoporosis: A Randomized Clinical Trial ↗PubMed PMID 27533157 · EFetch XML reviewed 2026-09-14 · payload SHA-256 6fc7a37a1f322b6c338bee074d13439ac49ee0e29213e49113bfcb18f82092c2
      No registered Crossref update in the reviewed snapshotChecked September 14, 2026 for DOI 10.1001/jama.2016.11136. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
    2. PubMed · 29800372ACTIVExtend: 24 Months of Alendronate After 18 Months of Abaloparatide or Placebo for Postmenopausal Osteoporosis ↗PubMed PMID 29800372 · EFetch XML reviewed 2026-09-14 · payload SHA-256 b734d5e42a384c3774541918b8e649c1ab725359b2d6aafc379a26cce8c15821
      No registered Crossref update in the reviewed snapshotChecked September 14, 2026 for DOI 10.1210/jc.2018-00163. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
    3. PubMed · 36190391The Efficacy and Safety of Abaloparatide-SC in Men With Osteoporosis: A Randomized Clinical Trial ↗PubMed PMID 36190391 · EFetch XML reviewed 2026-09-14 · payload SHA-256 505bd0197b0a42beff4ed79f51ab0a025b1ebdbd3d2dbf8fcdb7b354e1d0e75b
      No registered Crossref update in the reviewed snapshotChecked September 14, 2026 for DOI 10.1002/jbmr.4719. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
    Explore status sources, recent additions, and coverage gaps

    Living status brief

    What is the current status of Abaloparatide?

    U.S. label record. The cited DailyMed label identifies Abaloparatide and contains the product's official indications and warnings. This profile links to the label without restating it as medical guidance.

    The cited status sources were checked through September 15, 2026. This answer changes only through the profile’s visible version and correction history.

    Evidence present

    What records are connected here?

    Evidence lanes
    3
    Source years
    10
    Drugs@FDA applications
    1

    These are counts in PeptideScanner’s selected public collection, not measures of research quality, medical relevance, safety, or effectiveness.

    Coverage gaps

    What remains unknown or unsupported?

    PeptideScanner currently has no selected safety records connected to this profile. That is a collection gap, not evidence that no such records exist.

    PeptideScanner does not infer an answer where the cited records do not provide one. Open the source-linked records below to inspect their scope and limits.

    Explore the Evidence Map and record counts

    Evidence Map v1

    What kinds of records connect to Abaloparatide?

    Compare collection coverage →

    This map describes PeptideScanner’s selected, source-linked collection. It is not an evidence grade and does not establish research quality, safety, effectiveness, or medical relevance.

    60Selected dated records
    61Connected citations
    10Populated source years2017–2026
    3/4Record lanes present

    Registered human studies

    Trial composition

    2 of 9 selected trial records include at least one phase value; 2 of 9 include a status value in the retained structured contract.

    84 public history versions connect to 9 of these trial records across 9 submitted years. Open the record-history collection →

    3 exact source-declared trial-publication links connect selected NCT and PMID records. Open the exact graph →

    PhasesPhase 2 1Phase 3 1
    Status at observationCompleted 1Enrolling by invitation 1

    A phase value is unavailable here for 7 selected records; this is not counted as “no phase.”

    A status value is unavailable here for 7 selected records; this is not counted as a trial status.

    PubMed bibliography

    Publication composition

    9 of 33 selected PubMed records include attributed title, venue, publication date, and publication-type fields.

    Publication typesJournal Article 8Research Support, Non-U.S. Gov't 2Case Reports 1Clinical Trial, Phase I 1Published Erratum 1

    Bibliography fields unavailable here for 24 selected records; the records remain visible as metadata observations.

    Regulatory and publication surfaces

    What is structurally connected?

    Drugs@FDA applications
    1
    FDA Federal Register documents
    1
    DailyMed SPL versions
    16
    Canonical profile
    Published
    Profile structured data
    Published
    Linked dated records
    60

    Application counts reflect exact reviewed ingredient connections; Federal Register counts reflect exact reviewed peptide-name matches; DailyMed counts reflect listed SPL versions with retained ZIP receipts. “Published” describes this page’s indexing surface, not the state of scientific evidence.

    Profile publication history and record counts

    Exact identifier graph

    3 trial-publication links for Abaloparatide

    Open the full graph →

    These links come only from structured NCT and PMID identifiers declared by PubMed or ClinicalTrials.gov. They do not summarize the publications or establish findings.

    Research hub

    Explore the Abaloparatide evidence record

    Open all 60 records →
    60Dated records
    3Evidence types
    60Cited public sources
    10Source years

    Change ledger

    Recently changed for Abaloparatide

    Open all 62 events →

    PeptideScanner change dates and cited source dates stay separate. These entries report collection or version activity, not a ranking of importance.

    Correction

    Abaloparatide profile

    We refreshed this profile's label citation to the reviewed SPL version 19, published 2026-08-17. Earlier profile versions retain their original label citations. The product-specific label account identifies its reviewed scope.

    PeptideScanner change date
    September 15, 2026
    Evidence lane
    Profile
    Record added

    Abaloparatide DailyMed SPL version 1

    DailyMed lists Structured Product Labeling version 1 for the reviewed Abaloparatide label family with a published date of 2017-05-04. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.

    PeptideScanner change date
    August 22, 2026
    Cited source date
    May 4, 2017
    Evidence lane
    Regulatory
    Record added

    Abaloparatide DailyMed SPL version 10

    DailyMed lists Structured Product Labeling version 10 for the reviewed Abaloparatide label family with a published date of 2021-12-30. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.

    PeptideScanner change date
    August 22, 2026
    Cited source date
    December 30, 2021
    Evidence lane
    Regulatory

    Official-source collections

    Source records for Abaloparatide

    Open the full research atlas →
    PubMed33

    9 with attributed title, venue, publication-date, and type metadata.

    1. ▼Abaloparatide (Eladynos) for osteoporosis.Drug and therapeutics bulletin · 2025 06 30
    2. Biodegradable Nanoflowers with Abaloparatide Spatiotemporal Management of Functional Alveolar Bone Regeneration.Nano letters · 2024 02 13
    3. The use of abaloparatide to treat nonunion following dorsal closing wedge osteotomy for Freiberg's disease: A case report.Bone reports · 2021 10 30
    Explore all selected literature →
    ClinicalTrials.gov9

    84 public history versions across these dated registry records; status labels apply only to each cited observation.

    1. NCT07587775Registry update July 23, 2026 · current at observation
    2. NCT04467983Registry update June 8, 2026 · current at observation
    3. NCT04167163Registry update June 5, 2026 · completed at observation
    Explore all selected trial records →Explore all public record history →
    DailyMed SPL history16

    Version metadata and exact historical ZIP receipts for the reviewed label family, without reproducing or interpreting label text.

    1. SPL version 19Published 2026-08-17 · ZIP SHA-256 0972d261dcba…
    2. SPL version 18Published 2025-04-11 · ZIP SHA-256 bda05a2d8f2e…
    3. SPL version 16Published 2024-03-08 · ZIP SHA-256 d99a372f47d4…
    4. SPL version 15Published 2023-11-30 · ZIP SHA-256 6dc69e27f779…
    5. SPL version 13Published 2023-06-28 · ZIP SHA-256 e1f9923bcd38…
    Explore all DailyMed label versions →

    Counts and links describe PeptideScanner’s selected records. They are not rankings and do not establish research quality, safety, effectiveness, or medical relevance.

    Evidence types

    Coverage by source year

    Selected records span April 28, 2017 to August 17, 2026.

    Continue exploring

    Profiles with overlapping source-year coverage

    Open the research atlas →

    These links are based only on overlapping years and evidence lanes in PeptideScanner’s selected records. They do not imply that the peptides are medically or scientifically similar.

    Glucagon10 shared source years308 dated records · 4 evidence typesSemaglutide10 shared source years237 dated records · 4 evidence typesLeuprolide10 shared source years215 dated records · 4 evidence typesLiraglutide10 shared source years167 dated records · 4 evidence types

    These dates come from selected source records and PubMed metadata. They are not a complete or continuous timeline of research, safety, approval, or effectiveness.

    Evidence summary

    What the cited records say

    The cited DailyMed label identifies Abaloparatide and contains the product's official indications and warnings. This profile links to the label without restating it as medical guidance.

    This is a source summary, not a medical recommendation. Status may differ by jurisdiction and product.

    Cited context

    Related records

    Organizations named in cited records

    • U.S. National Library of Medicine

    Dated source history

    Updates connected to this profile

    Open the full cross-source timeline →
    1. Regulatory

      Abaloparatide DailyMed SPL version 19

      DailyMed lists Structured Product Labeling version 19 for the reviewed Abaloparatide label family with a published date of 2026-08-17. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.

    2. Literature metadata

      PubMed record PMID 41812602

      PeptideScanner retained PubMed bibliographic metadata for PMID 41812602 at 2026-08-10T10:49:08.791Z. PubMed recorded a metadata revision date of 2026-08-03 and an Entrez history date of 2026-03-11. PeptideScanner associated this retained record with the identity slug abaloparatide. These dates describe PubMed metadata history, not the article's original publication date.

    3. Literature metadata

      PubMed record PMID 42351259

      PeptideScanner retained PubMed bibliographic metadata for PMID 42351259 at 2026-08-10T18:13:52.323Z. PubMed recorded a metadata revision date of 2026-07-26 and an Entrez history date of 2026-06-26. PeptideScanner associated this retained record with the identity slug abaloparatide. These dates describe PubMed metadata history, not the article's original publication date.

    4. Literature metadata

      PubMed record PMID 42498818

      PeptideScanner retained PubMed bibliographic metadata for PMID 42498818 at 2026-08-10T18:13:56.743Z. PubMed recorded a metadata revision date of 2026-07-24 and an Entrez history date of 2026-07-24. PeptideScanner associated this retained record with the identity slug abaloparatide. These dates describe PubMed metadata history, not the article's original publication date.

    5. Clinical trials

      ClinicalTrials.gov record NCT07587775

      PeptideScanner retained ClinicalTrials.gov record NCT07587775 at 2026-08-10T18:10:03.948Z. Its registry update date was 2026-07-23, and PeptideScanner's reviewed identity mapping was abaloparatide.

    6. Literature metadata

      PubMed record PMID 41714054

      PeptideScanner retained PubMed bibliographic metadata for PMID 41714054 at 2026-08-10T18:13:42.699Z. PubMed recorded a metadata revision date of 2026-07-08 and an Entrez history date of 2026-02-19. PeptideScanner associated this retained record with the identity slug abaloparatide. These dates describe PubMed metadata history, not the article's original publication date.

    7. Literature metadata

      PubMed record PMID 39789749

      PeptideScanner retained PubMed bibliographic metadata for PMID 39789749 at 2026-08-10T18:13:36.068Z. PubMed recorded a metadata revision date of 2026-07-07 and an Entrez history date of 2025-01-10. PeptideScanner associated this retained record with the identity slug abaloparatide. These dates describe PubMed metadata history, not the article's original publication date.

    8. Literature metadata

      PubMed record PMID 41579168

      PeptideScanner retained PubMed bibliographic metadata for PMID 41579168 at 2026-07-30T16:11:44.866Z. PubMed recorded a metadata revision date of 2026-07-01 and an Entrez history date of 2026-01-24. PeptideScanner associated this retained record with the identity slug abaloparatide. These dates describe PubMed metadata history, not the article's original publication date.

    9. Literature metadata

      PubMed record PMID 42033613

      PeptideScanner retained PubMed bibliographic metadata for PMID 42033613 at 2026-07-30T16:14:16.695Z. PubMed recorded a metadata revision date of 2026-06-27 and an Entrez history date of 2026-04-25. PeptideScanner associated this retained record with the identity slug abaloparatide. These dates describe PubMed metadata history, not the article's original publication date.

    10. Literature metadata

      PubMed record PMID 41023931

      PeptideScanner retained PubMed bibliographic metadata for PMID 41023931 at 2026-07-30T16:14:12.886Z. PubMed recorded a metadata revision date of 2026-06-26 and an Entrez history date of 2025-09-30. PeptideScanner associated this retained record with the identity slug abaloparatide. These dates describe PubMed metadata history, not the article's original publication date.

    11. Literature metadata

      PubMed record PMID 41506099

      PeptideScanner retained PubMed bibliographic metadata for PMID 41506099 at 2026-07-30T16:14:13.082Z. PubMed recorded a metadata revision date of 2026-06-25 and an Entrez history date of 2026-01-08. PeptideScanner associated this retained record with the identity slug abaloparatide. These dates describe PubMed metadata history, not the article's original publication date.

    12. Literature metadata

      PubMed record PMID 40890141

      PeptideScanner retained PubMed bibliographic metadata for PMID 40890141 at 2026-07-30T16:14:11.108Z. PubMed recorded a metadata revision date of 2026-06-19 and an Entrez history date of 2025-09-01. PeptideScanner associated this retained record with the identity slug abaloparatide. These dates describe PubMed metadata history, not the article's original publication date.