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.
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
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 →
Voxzogo · Read September 15, 2026 · Preserved label summary 1
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 ↗
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 ↗
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 ↗
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.
This account summarizes the cited product label. A separate appraisal of the complete clinical literature and other jurisdictions remains open.
Reviewed 2026-09-16 · Preserved version 1
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 ↗
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 ↗
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.
Protocol identifiers were matched to ClinicalTrials.gov records. This does not count extensions as new independent trials.
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 ↗
Page references use one-based PDF file pages, which can differ from printed page numbers. Candidate feed associations are not verified application identities.
Selected sections reviewed · fda-vosoritide-fda-2021 · Document/feed date: 2021-11-18
Historical approval-package review; later labels and postmarketing outcomes require separate reconciliation.
Verified: Voxzogo · NDA 214938 · Document dated 2021-11-18. 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, 24, 25, 26, 28, 29, 55, 56, 65, 66, 67, 68, 69, 70, 71, 72, 73, 303 of 303. SHA-256: 064c01fbb285fcb422fe0386108dae7e4ab74518f5f2dbeabaced897ba41ddd5.
Not yet reviewed · ema-51585 · Document/feed date: 2021-06-25
Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.
Not yet reviewed · ema-52404 · Document/feed date: 2021-09-09
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/005475.
Not yet reviewed · ema-52411 · Document/feed date: 2021-09-09
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/005475.
Not yet reviewed · ema-54273 · Document/feed date: 2022-02-24
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/005475.
Not yet reviewed · ema-59974 · Document/feed date: 2023-09-15
Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.
Not yet reviewed · ema-52402 · Document/feed date: 2021-09-09
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/005475.
Not yet reviewed · ema-52400 · Document/feed date: 2023-11-24
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/005475.
Not yet reviewed · ema-60980 · Document/feed date: 2023-11-21
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/005475.
Not yet reviewed · ema-61841 · Document/feed date: 2024-01-23
Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.
Not yet reviewed · ema-64187 · Document/feed date: 2024-07-17
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/005475.
Not yet reviewed · ema-60192 · Document/feed date: 2023-09-28
Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.
Not yet reviewed · ema-58464 · Document/feed date: 2023-04-19
Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.
Not yet reviewed · ema-52403 · Document/feed date: 2025-03-20
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/005475.
Not yet reviewed · ema-59006 · Document/feed date: 2024-07-17
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/005475.
Not yet reviewed · ema-69137 · Document/feed date: 2025-07-07
Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.
Not yet reviewed · ema-72959 · Document/feed date: 2026-03-11
Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.
Not yet reviewed · ema-74056 · Document/feed date: 2026-06-11
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/005475.
Not yet reviewed · ema-74407 · Document/feed date: 2026-07-01
Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.
Not yet reviewed · ema-68464 · Document/feed date: 2026-08-13
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/005475.
Not yet reviewed · ema-74966 · Document/feed date: 2026-08-13
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/005475.
Not yet reviewed · ema-52401 · Document/feed date: 2026-08-13
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/005475.
EMA medicine metadata checked 2026-09-15. These are product-specific centralized records; national European authorizations and full product-information assessments require separate coverage.
Authorised · EMEA/H/C/005475
Active substance as listed: vosoritide. EMA record ↗
Marketing authorisation: 2021-08-26. EMA metadata last updated 2026-08-13. EMA metadata ↗
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.
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 →
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
"vosoritide"[Title/Abstract] OR "BMN 111"[Title/Abstract] OR "BMN111"[Title/Abstract] OR "Voxzogo"[Title/Abstract]
Retrieved 2026-09-15T11:10:57.798753+00:00 · HTTP 200 · SHA-256 1bb5efacabe808e7a7779266b2361a011d5ba860da536b681d1f10a2c88aa11f.
Showing 25 of 124 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
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
products.active_ingredients.name:"VOSORITIDE"
Retrieved 2026-09-15T11:10:31.709443+00:00 · HTTP 200 · SHA-256 a67fc69f2ddcb73e09f586281eb28d52918d2552bd28de7f2b5435d0aef7a38b.
Showing 1 of 1 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
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
Case-insensitive word-boundary identity terms: ["Vosoritide", "Voxzogo"]
Retrieved 2026-09-15T08:34:22.905972+00:00 · HTTP 200 · SHA-256 a947c2b8a56ac2b92ec96156843f262f5e516f83b375d6791d67a8f6dc695729.
Showing 1 of 1 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
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
Case-insensitive word-boundary identity terms: ["Vosoritide", "Voxzogo"]
Retrieved 2026-09-15T08:34:29.167460+00:00 · HTTP 200 · SHA-256 c0c68d7d77783e0355cbc75bdd04772e9acc163236fc68abcd794477c4c3d439.
Showing 23 of 23 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
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
Case-insensitive word-boundary identity terms: ["Vosoritide", "Voxzogo"]
Retrieved 2026-09-15T08:34:31.262344+00:00 · HTTP 200 · SHA-256 7448bf4e77e3345b3f3fbb7062c335d2302d8ea458a246bbe8256ce48aad2806.
Showing 2 of 2 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
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
"Vosoritide" OR "Voxzogo"
Retrieved 2026-09-15T11:27:17.800323+00:00 · HTTP 200 · SHA-256 0af9c88f8ad176de14c8ee357bd306e43d9a7487138e5b0f6b363f38f4178f61.
Showing 18 of 18 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
Living status brief
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.
These are counts in PeptideScanner’s selected public collection, not measures of research quality, medical relevance, safety, or effectiveness.
Literature metadata · source date September 9, 2026
A Phase 3 Trial of Vosoritide in Children with Hypochondroplasia.↗Added to PeptideScanner September 9, 2026Literature metadata · added September 9, 2026
A Phase 3 Trial of Vosoritide in Children with Hypochondroplasia.↗Source date September 9, 2026Clinical trials · added September 9, 2026
ClinicalTrials.gov record NCT03989947↗Source date March 13, 2026Clinical trials · added September 9, 2026
ClinicalTrials.gov record NCT02055157↗Source date January 15, 2021PeptideScanner 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.
Evidence Map v1
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.
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 →
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.
9 of 33 selected PubMed records include attributed title, venue, publication date, and publication-type fields.
Bibliography fields unavailable here for 24 selected records; the records remain visible as metadata observations.
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.
Exact identifier 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.
Declared by both sources
ClinicalTrials.gov type: DERIVED
Declared by both sources
ClinicalTrials.gov type: DERIVED
Research hub
PeptideScanner change dates and cited source dates stay separate. These entries report collection or version activity, not a ranking of importance.
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 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.
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.
9 with attributed title, venue, publication-date, and type metadata.
64 public history versions across these dated registry records; status labels apply only to each cited observation.
Original-submission application metadata connected by exact reviewed active-ingredient names.
FDA- and HHS-attributed document metadata connected by exact reviewed peptide-name matches, with official GovInfo PDFs.
Version metadata and exact historical ZIP receipts for the reviewed label family, without reproducing or interpreting label text.
Counts and links describe PeptideScanner’s selected records. They are not rankings and do not establish research quality, safety, effectiveness, or medical relevance.
Selected records span January 15, 2021 to September 9, 2026.
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.
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
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.↗
Cited context
Dated source history
Literature metadata
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.↗
Literature metadata
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.↗
Literature metadata
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.↗
Literature metadata
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.↗
Regulatory
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.↗
Literature metadata
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.↗
Literature metadata
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.↗
Literature metadata
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.↗
Literature metadata
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.↗
Literature metadata
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.↗
Literature metadata
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.↗
Literature metadata
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.↗