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Vosoritide regulatory status

Current status of Vosoritide in the United States: FDA approved. In sport: WADA status unclear. Details, sources, and the dated timeline follow.

By the PeptideAgent Editorial Team. Draft, pending editorial review.  Last verified

What is the current status of Vosoritide?

Regulatory: FDA approvedWADA: WADA status unclearVerified: Verified Sep 23, 2026
FDA and compounding
FDA approved prescription drug (Voxzogo, approved November 19, 2021 for achondroplasia in children 5 and older with open epiphyses; expanded in October 2023 to all ages with open epiphyses). Commercially available, so it is not eligible for routine compounding and is not on any 503A bulks list. Some research chemical sellers list it, but those products are not lawful for human use and have no place in achondroplasia care.
WADA
WADA status unclear
Access path
  1. Prescription from a pediatric endocrinologist or geneticist, dispensed through a specialty pharmacy as Voxzogo.
  2. Not available through compounding pharmacies or telehealth peptide clinics; research chemical products are not lawful for human use.

Full Vosoritide page: evidence, dosing in the literature, and sources

How has the status of Vosoritide changed over time?

  1. FDA

    FDA approves Voxzogo (vosoritide) for achondroplasia

    FDA approved vosoritide injection (Voxzogo), a C-type natriuretic peptide analog, to increase linear growth in children with achondroplasia and open epiphyses, under accelerated approval.

    Regulatory: FDA approvedSource: Drugs@FDA: Voxzogo (vosoritide) NDA 214938

Sources

Numbered citations in the answers above point here, followed by the regulatory sources on record for Vosoritide and the source of each dated event.

  1. [1]FDA news release: FDA approves first drug to improve growth in children with most common form of dwarfism (November 2021)FDA, 2021
  2. [2]FDA prescribing information for Voxzogo (vosoritide) for injection, via DailyMedFDA, 2025
  3. [3]WADA Prohibited ListWADA, 2026
  4. [4]Drugs@FDA: Voxzogo (vosoritide) NDA 214938FDA, 2021