U.S. label recordRare disease

Vosoritide

Related names in cited records: Voxzogo

A C-type natriuretic peptide analogue. This profile cites a U.S. label record.

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

Profile update · July 27, 2026

We rewrote the profile summary to describe the cited public record more directly. The cited sources and status did not change. 1

This version supersedes public version 1.

Start here

The evidence at a glance

What is its status in the cited records?

U.S. label record. The cited DailyMed label identifies Vosoritide 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 July 22, 2026. See status sources and coverage →

What does the U.S. product label say?

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

Which population and use does the label cover?

The cited U.S. label covers increased linear growth in pediatric patients with achondroplasia and open growth plates. Accelerated approval is based on annualized growth velocity; continued approval depends on confirmation of clinical benefit. Label: 1 ↗

What clinical outcome supported the label?

The label describes a 52-week randomized placebo-controlled study in 121 children with achondroplasia. The adjusted difference in annualized growth velocity was 1.57 cm per year in favor of vosoritide. This growth-rate endpoint does not establish final adult height or every functional outcome; extension participants overlap the original trial. Label: 14 ↗

Which safety limits matter?

The label describes transient decreases in blood pressure. Its growth-velocity finding is not itself proof of improved adult height or all functional outcomes. Label: 1, 5, 14 ↗

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.

VOXZOGO (vosoritide) kit · SPL version 16 · published 2025-11-26

Label ZIP SHA-256: 01bd93709f678ebf940f87c036fa3fe74fef3e457891d243c5c4e759d0253924. Extracted XML SHA-256: 3faeddb93511f0bc64c4bd0e70f367ced4dcb0b45a2b9864ad5ad67026080e89.

Open versioned label context data →

What remains unresolved?

This account summarizes the cited product label. A separate appraisal of the complete clinical literature and other jurisdictions remains open.

Inside the official reviews

Reviewed 2026-09-16 · Preserved version 1

What did accelerated approval establish?

FDA’s 2021 review supported increased linear growth, based on annualized growth velocity, and required confirmation of benefit on final adult height. The original age threshold in that review is historical; see the separately dated U.S. label account for the labeling covered by this site. FDA PDF pp. 2, 24 ↗

More findings, study links and document coverage

What did the trial leave unanswered?

Study 111-301 showed a 1.57 cm/year adjusted growth-velocity difference at one year (95% CI 1.22–1.93). FDA did not treat that result as proof of improved final adult height or all achondroplasia complications. Longer follow-up and external-control comparisons had different evidentiary limits from the randomized trial. FDA PDF pp. 25, 26, 69, 71 ↗

How should follow-up studies be counted?

Study 111-302 extended 111-301 with open-label treatment. FDA’s historical review used it as supportive follow-up, not a second independent placebo-controlled trial. Four participants from the separate 111-205 study had reached near-final height in the original submission; that small observation did not settle the final-height question. FDA PDF pp. 55, 56, 72, 73 ↗

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 1 of 22 inventoried documents; 21 not yet reviewed. Reading selected sections does not establish complete appraisal of a document.

English PDF entries containing Voxzogo 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.

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 · 1 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

Vosoritide and validated product/development-name PubMed discovery; complete query retrieval is separate from screening and appraisal.

124 retrieved · 1 included · 0 excluded · 123 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

"vosoritide"[Title/Abstract] OR "BMN 111"[Title/Abstract] OR "BMN111"[Title/Abstract] OR "Voxzogo"[Title/Abstract]

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:10:57.798753+00:00 · HTTP 200 · SHA-256 1bb5efacabe808e7a7779266b2361a011d5ba860da536b681d1f10a2c88aa11f.

  • A scoped product-label account is available separately; it is not an independent literature review.
  • Other aliases, parent molecules, study-family linkage and full-text appraisal remain separate work.
  • PMID32891212 has a publisher correction, PMID33038967. Its effects are unresolved; the clinical label account is independently attributed to the label.

Showing 25 of 124 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. PubMed 32891212 — include: Eligible human trial report; full-text and publisher-correction assessment remain unavailable, so no independent clinical summary is published here.
  2. PubMed 42714340 — not screened: Name-query match awaiting clinical eligibility screening.
  3. PubMed 42713641 — not screened: Name-query match awaiting clinical eligibility screening.
  4. PubMed 42696489 — not screened: Name-query match awaiting clinical eligibility screening.
  5. PubMed 42694461 — not screened: Name-query match awaiting clinical eligibility screening.
  6. PubMed 42678892 — not screened: Name-query match awaiting clinical eligibility screening.
  7. PubMed 42675811 — not screened: Name-query match awaiting clinical eligibility screening.
  8. PubMed 42651392 — not screened: Name-query match awaiting clinical eligibility screening.
  9. PubMed 42650460 — not screened: Name-query match awaiting clinical eligibility screening.
  10. PubMed 42591755 — not screened: Name-query match awaiting clinical eligibility screening.
  11. PubMed 42519733 — not screened: Name-query match awaiting clinical eligibility screening.
  12. PubMed 42518139 — not screened: Name-query match awaiting clinical eligibility screening.
  13. PubMed 42495828 — not screened: Name-query match awaiting clinical eligibility screening.
  14. PubMed 42479670 — not screened: Name-query match awaiting clinical eligibility screening.
  15. PubMed 42466325 — not screened: Name-query match awaiting clinical eligibility screening.
  16. PubMed 42306228 — not screened: Name-query match awaiting clinical eligibility screening.
  17. PubMed 42285849 — not screened: Name-query match awaiting clinical eligibility screening.
  18. PubMed 42238253 — not screened: Name-query match awaiting clinical eligibility screening.
  19. PubMed 42154634 — not screened: Name-query match awaiting clinical eligibility screening.
  20. PubMed 42043535 — not screened: Name-query match awaiting clinical eligibility screening.
  21. PubMed 42028063 — not screened: Name-query match awaiting clinical eligibility screening.
  22. PubMed 42026358 — not screened: Name-query match awaiting clinical eligibility screening.
  23. PubMed 42001280 — not screened: Name-query match awaiting clinical eligibility screening.
  24. PubMed 41967490 — not screened: Name-query match awaiting clinical eligibility screening.
  25. PubMed 20301331 — 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:"VOSORITIDE"

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:10:31.709443+00:00 · HTTP 200 · SHA-256 a67fc69f2ddcb73e09f586281eb28d52918d2552bd28de7f2b5435d0aef7a38b.

  • 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 NDA214938 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: VOSORITIDE.

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.

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

Search terms, record decisions and remaining work

Case-insensitive word-boundary identity terms: ["Vosoritide", "Voxzogo"]

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 1 of 1 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/005475 — include: EMA feed product Voxzogo; reported status: Authorised. 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.

23 retrieved · 13 included · 0 excluded · 10 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

Case-insensitive word-boundary identity terms: ["Vosoritide", "Voxzogo"]

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 23 of 23 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. EMA 52404 — include: Document linked by EMA product number; content unappraised. Voxzogo : EPAR - Public assessment report
  2. EMA 52411 — include: Document linked by EMA product number; content unappraised. Voxzogo : Orphan maintenance assessment report (initial authorisation)
  3. EMA 54273 — include: Document linked by EMA product number; content unappraised. Voxzogo-H-C-005475-P46-007 : EPAR - Assessment report
  4. EMA 52402 — include: Document linked by EMA product number; content unappraised. Voxzogo : EPAR - All authorised presentations
  5. EMA 52400 — include: Document linked by EMA product number; content unappraised. Voxzogo : EPAR - Medicine overview
  6. EMA 60980 — include: Document linked by EMA product number; content unappraised. Voxzogo-H-C-005475-II-0006 : EPAR - Assessment report - Variation
  7. EMA 64187 — include: Document linked by EMA product number; content unappraised. Voxzogo-H-C-PSUSA-00010952-202308: EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
  8. EMA 52403 — include: Document linked by EMA product number; content unappraised. Voxzogo : EPAR - Risk management plan summary
  9. EMA 59006 — include: Document linked by EMA product number; content unappraised. Voxzogo : EPAR - Procedural steps taken and scientific information after authorisation (archive)
  10. EMA 74056 — include: Document linked by EMA product number; content unappraised. Voxzogo : EPAR - Statement indicating compliance with the agreed completed paediatric investigation plan
  11. EMA 68464 — include: Document linked by EMA product number; content unappraised. Voxzogo : EPAR - Procedural steps taken and scientific information after authorisation
  12. EMA 74966 — include: Document linked by EMA product number; content unappraised. Voxzogo-PSUSA-00010952-202508: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
  13. EMA 52401 — include: Document linked by EMA product number; content unappraised. Voxzogo : EPAR - Product information
  14. EMA 51585 — not screened: Title-name match awaiting identity and document review. CHMP summary of positive opinion for Voxzogo
  15. EMA 59974 — not screened: Title-name match awaiting identity and document review. CHMP post-authorisation summary of positive opinion for Voxzogo (II-06)
  16. EMA 61841 — not screened: Title-name match awaiting identity and document review. Direct healthcare professional communication (DHPC) : Voxzogo (vosoritide): change to administration syringe and needle leading to product administration in Units (U) instead of mL
  17. EMA 60192 — not screened: Title-name match awaiting identity and document review. P/0453/2022 : EMA decision of 24 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for vosoritide (Voxzogo), (EMEA-002033-PIP01-16-M03)
  18. EMA 58464 — not screened: Title-name match awaiting identity and document review. P/0051/2022 : EMA decision of 11 March 2022 on the acceptance of a modification of an agreed paediatric investigation plan for vosoritide (Voxzogo), (EMEA-002033-PIP01-16-M02)
  19. EMA 47991 — not screened: Title-name match awaiting identity and document review. P/0060/2020: EMA decision of 10 February 2020 on the acceptance of a modification of an agreed paediatric investigation plan for vosoritide (BMN 111), (EMEA-002033-PIP01-16-M01)
  20. EMA 32628 — not screened: Title-name match awaiting identity and document review. P/0379/2017: EMA decision of 19 December 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral for vosoritide (BMN 111) (EMEA-002033-PIP01-16)
  21. EMA 69137 — not screened: Title-name match awaiting identity and document review. P/0286/2024: EMA decision of 16 August 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral for vosoritide (Voxzogo), (EMEA-002033-PIP02-23)
  22. EMA 72959 — not screened: Title-name match awaiting identity and document review. EMA/PE/0000224768 : EMA decision of 28 January 2025 on the acceptance of a modification of an agreed paediatric investigation plan for vosoritide (Voxzogo)
  23. EMA 74407 — not screened: Title-name match awaiting identity and document review. EMA/PE/0000224087 : EMA decision of 16 April 2025 on the acceptance of a modification of an agreed paediatric investigation plan for vosoritide (Voxzogo)

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.

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: ["Vosoritide", "Voxzogo"]

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 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 EU/3/24/2998 — include: EMA orphan feed identifies vosoritide; designation status: Positive. Orphan designation is not marketing authorization.
  2. EMA EU/3/12/1094 — include: EMA orphan feed identifies modified recombinant human C-type natriuretic peptide (Vosoritide); designation status: Positive. Orphan designation is not marketing authorization.

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.

18 retrieved · 0 included · 0 excluded · 18 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

"Vosoritide" OR "Voxzogo"

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:27:17.800323+00:00 · HTTP 200 · SHA-256 0af9c88f8ad176de14c8ee357bd306e43d9a7487138e5b0f6b363f38f4178f61.

  • 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 18 of 18 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. ClinicalTrials.gov NCT03583697 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  2. ClinicalTrials.gov NCT05845749 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  3. ClinicalTrials.gov NCT03424018 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  4. ClinicalTrials.gov NCT03197766 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  5. ClinicalTrials.gov NCT06168201 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  6. ClinicalTrials.gov NCT07441876 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  7. ClinicalTrials.gov NCT02055157 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  8. ClinicalTrials.gov NCT03989947 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  9. ClinicalTrials.gov NCT06668805 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  10. ClinicalTrials.gov NCT06382155 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  11. ClinicalTrials.gov NCT07126262 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  12. ClinicalTrials.gov NCT04219007 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  13. ClinicalTrials.gov NCT06455059 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  14. ClinicalTrials.gov NCT05849389 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  15. ClinicalTrials.gov NCT07073014 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  16. ClinicalTrials.gov NCT04554940 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  17. ClinicalTrials.gov NCT02724228 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  18. ClinicalTrials.gov NCT01590446 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
Explore status sources, recent additions, and coverage gaps

Living status brief

What is the current status of Vosoritide?

U.S. label record. The cited DailyMed label identifies Vosoritide 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 July 22, 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
6
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 Vosoritide?

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.

56Selected dated records
57Connected citations
6Populated source years2021–2026
3/4Record lanes present

Registered human studies

Trial composition

4 of 10 selected trial records include at least one phase value; 4 of 10 include a status value in the retained structured contract.

64 public history versions connect to 8 of these trial records across 11 submitted years. Open the record-history collection →

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

PhasesPhase 2 4
Status at observationActive, not recruiting 2Completed 1Recruiting 1

A phase value is unavailable here for 6 selected records; this is not counted as “no phase.”

A status value is unavailable here for 6 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 8Review 2Case Reports 1Comment 1Editorial 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
5
DailyMed SPL versions
7
Canonical profile
Published
Profile structured data
Published
Linked dated records
56

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

2 trial-publication links for Vosoritide

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 Vosoritide evidence record

Open all 56 records →
56Dated records
3Evidence types
56Cited public sources
6Source years

Change ledger

Recently changed for Vosoritide

Open all 57 events →

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

Record added

ClinicalTrials.gov record NCT02055157

PeptideScanner retained ClinicalTrials.gov record NCT02055157 at 2026-07-30T20:07:13.490Z. Its registry update date was 2021-01-15, and PeptideScanner's reviewed identity mapping was vosoritide.

PeptideScanner change date
September 9, 2026
Cited source date
January 15, 2021
Evidence lane
Clinical trials
Record added

ClinicalTrials.gov record NCT03989947

PeptideScanner retained ClinicalTrials.gov record NCT03989947 at 2026-07-30T16:22:22.327Z. Its registry update date was 2026-03-13, and PeptideScanner's reviewed identity mapping was vosoritide.

PeptideScanner change date
September 9, 2026
Cited source date
March 13, 2026
Evidence lane
Clinical trials
Record added

A Phase 3 Trial of Vosoritide in Children with Hypochondroplasia.

PubMed lists PMID 42713641 in NEJM evidence as Journal Article, with publication-date metadata of 2026-09-09 (day precision). PeptideScanner associated the retained record with the identity slug vosoritide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.

PeptideScanner change date
September 9, 2026
Cited source date
September 9, 2026
Evidence lane
Literature metadata

Official-source collections

Source records for Vosoritide

Open the full research atlas →
PubMed33

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

  1. A Phase 3 Trial of Vosoritide in Children with Hypochondroplasia.NEJM evidence · 2026 09 09
  2. Three-dimensional craniofacial imaging in children with achondroplasia treated with vosoritide.Genetics in medicine open · 2025 10 13
  3. Thanatophoric Dysplasia Type 1 Treated with Vosoritide: A Case Report.Hormone research in paediatrics · 2025 10 10
Explore all selected literature →
ClinicalTrials.gov10

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

  1. NCT07126262Registry update March 31, 2026 · current at observation
  2. NCT04219007Registry update March 18, 2026 · current at observation
  3. NCT02724228Registry update March 13, 2026 · current at observation
Explore all selected trial records →Explore all public record history →
DailyMed SPL history7

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

  1. SPL version 16Published 2025-11-26 · ZIP SHA-256 01bd93709f67…
  2. SPL version 15Published 2024-12-20 · ZIP SHA-256 67c91f544815…
  3. SPL version 14Published 2024-11-13 · ZIP SHA-256 d307e9e4a58e…
  4. SPL version 12Published 2024-04-15 · ZIP SHA-256 d005e7bc5ddc…
  5. SPL version 11Published 2024-04-12 · ZIP SHA-256 be8f9c1d8d00…
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 January 15, 2021 to September 9, 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.

Glucagon6 shared source years308 dated records · 4 evidence typesSemaglutide6 shared source years237 dated records · 4 evidence typesLeuprolide6 shared source years215 dated records · 4 evidence typesLiraglutide6 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 Vosoritide 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. Literature metadata

    A Phase 3 Trial of Vosoritide in Children with Hypochondroplasia.

    PubMed lists PMID 42713641 in NEJM evidence as Journal Article, with publication-date metadata of 2026-09-09 (day precision). PeptideScanner associated the retained record with the identity slug vosoritide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.

  2. Literature metadata

    PubMed record PMID 42026358

    PeptideScanner retained PubMed bibliographic metadata for PMID 42026358 at 2026-08-10T10:49:08.854Z. PubMed recorded a metadata revision date of 2026-08-06 and an Entrez history date of 2026-04-23. PeptideScanner associated this retained record with the identity slug vosoritide. These dates describe PubMed metadata history, not the article's original publication date.

  3. Literature metadata

    PubMed record PMID 41764752

    PeptideScanner retained PubMed bibliographic metadata for PMID 41764752 at 2026-08-10T10:49:08.778Z. PubMed recorded a metadata revision date of 2026-07-31 and an Entrez history date of 2026-03-01. PeptideScanner associated this retained record with the identity slug vosoritide. These dates describe PubMed metadata history, not the article's original publication date.

  4. Literature metadata

    PubMed record PMID 41424367

    PeptideScanner retained PubMed bibliographic metadata for PMID 41424367 at 2026-08-10T10:49:08.725Z. PubMed recorded a metadata revision date of 2026-07-30 and an Entrez history date of 2025-12-22. PeptideScanner associated this retained record with the identity slug vosoritide. These dates describe PubMed metadata history, not the article's original publication date.

  5. Regulatory

    Federal Register notice 2026-15285

    The Federal Register published notice 2026-15285, attributed to FDA and its parent HHS department, on 2026-07-29. Its official title is “Product-Specific Guidances; Revised Draft Guidances for Industry; Availability,” and PeptideScanner's exact reviewed identity mapping connects the document to Glucagon, Liraglutide, Semaglutide, Teriparatide, Tirzepatide and Vosoritide.

  6. Literature metadata

    PubMed record PMID 42518139

    PeptideScanner retained PubMed bibliographic metadata for PMID 42518139 at 2026-08-10T18:13:56.769Z. PubMed recorded a metadata revision date of 2026-07-29 and an Entrez history date of 2026-07-28. PeptideScanner associated this retained record with the identity slug vosoritide. These dates describe PubMed metadata history, not the article's original publication date.

  7. Literature metadata

    PubMed record PMID 42519733

    PeptideScanner retained PubMed bibliographic metadata for PMID 42519733 at 2026-08-10T18:13:56.777Z. PubMed recorded a metadata revision date of 2026-07-29 and an Entrez history date of 2026-07-28. PeptideScanner associated this retained record with the identity slug vosoritide. These dates describe PubMed metadata history, not the article's original publication date.

  8. Literature metadata

    PubMed record PMID 42495828

    PeptideScanner retained PubMed bibliographic metadata for PMID 42495828 at 2026-08-10T18:13:56.737Z. 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 vosoritide. These dates describe PubMed metadata history, not the article's original publication date.

  9. Literature metadata

    PubMed record PMID 41810698

    PeptideScanner retained PubMed bibliographic metadata for PMID 41810698 at 2026-08-10T18:13:44.816Z. PubMed recorded a metadata revision date of 2026-07-23 and an Entrez history date of 2026-03-11. PeptideScanner associated this retained record with the identity slug vosoritide. These dates describe PubMed metadata history, not the article's original publication date.

  10. Literature metadata

    PubMed record PMID 42479670

    PeptideScanner retained PubMed bibliographic metadata for PMID 42479670 at 2026-08-10T18:13:56.698Z. PubMed recorded a metadata revision date of 2026-07-21 and an Entrez history date of 2026-07-21. PeptideScanner associated this retained record with the identity slug vosoritide. These dates describe PubMed metadata history, not the article's original publication date.

  11. Literature metadata

    PubMed record PMID 42001280

    PeptideScanner retained PubMed bibliographic metadata for PMID 42001280 at 2026-08-10T18:13:48.756Z. PubMed recorded a metadata revision date of 2026-07-17 and an Entrez history date of 2026-04-19. PeptideScanner associated this retained record with the identity slug vosoritide. These dates describe PubMed metadata history, not the article's original publication date.

  12. Literature metadata

    PubMed record PMID 41762856

    PeptideScanner retained PubMed bibliographic metadata for PMID 41762856 at 2026-08-10T18:13:42.759Z. PubMed recorded a metadata revision date of 2026-07-09 and an Entrez history date of 2026-02-28. PeptideScanner associated this retained record with the identity slug vosoritide. These dates describe PubMed metadata history, not the article's original publication date.