Bones & muscles CNP analog
Vosoritide
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- An FDA-approved product contains this peptide
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
If you think you are having a medical emergency, call 911.
Key takeaway
Vosoritide (sold as Voxzogo) is a modified form of C-type natriuretic peptide used to increase growth in children with achondroplasia, a genetic condition in which overactive FGFR3 signaling slows bone growth. It counteracts the overactive growth signal that restrains bone growth in the condition. It has been FDA-approved in the U.S. since 2021 and is given as a daily subcutaneous injection.
At a glance
- What it is
- A modified analog of C-type natriuretic peptide (CNP)
- Approved for
- Achondroplasia in children with open growth plates
- Key fact
- In a phase 3 trial it increased annual growth velocity by about 1.6 cm per year versus placebo
- Route
- Subcutaneous injection, once daily
- Evidence strength
- FDA approved
Summary
Vosoritide (Voxzogo) is an FDA-approved peptide that increases growth in children with achondroplasia. Learn how it works, its side effects, and the evidence.
What is vosoritide?
Vosoritide, sold under the brand Voxzogo, is a modified analog of C-type natriuretic peptide (CNP), a signaling molecule involved in bone growth. It is used to increase height in children with achondroplasia, a genetic condition caused by an overactive FGFR3 gene that slows the growth of bones at the growth plate. It was developed under the code BMN-111 and approved in the United States in 2021.
How does vosoritide work?
In achondroplasia, a mutation leaves the FGFR3 receptor constantly switched on, and its downstream signaling suppresses the growth of cartilage cells at the growth plate, limiting bone lengthening. Vosoritide binds a different receptor, natriuretic peptide receptor-B, which raises cyclic GMP inside those cartilage cells and inhibits the overactive FGFR3 pathway. By counteracting that brake, it allows more normal growth of the long bones.
Natural CNP is broken down within minutes; vosoritide is engineered to last long enough for once-daily dosing. In the phase 3 trial, children on vosoritide grew about 1.6 cm per year faster than those on placebo, and it is used while the growth plates remain open. A known effect is a transient drop in blood pressure, so children are given food and fluid before dosing.
Is it FDA-approved?
Editor’s note
Status: Yes. Vosoritide (Voxzogo) was approved by the FDA in 2021 for achondroplasia in children with open epiphyses (growth plates). It holds accelerated approval, based on faster annual growth, and continued approval may depend on confirmatory trials. The approved age range was initially 5 years and older, and since October 2023 it covers children of all ages with open growth plates.
Category: FDA-approved · Primary body area: Bones & muscles
Yes. Vosoritide (Voxzogo) was approved by the FDA in 2021 for achondroplasia in children with open epiphyses (growth plates). It holds accelerated approval, based on faster annual growth, and continued approval may depend on confirmatory trials. The approved age range was initially 5 years and older, and since October 2023 it covers children of all ages with open growth plates.
What is vosoritide prescribed for?
Vosoritide is prescribed to increase linear growth in children with achondroplasia who still have open growth plates. Treatment stops once the growth plates close, since the drug works through active bone growth.
What are the side effects?
According to the prescribing information, common side effects include:
- Injection-site reactions
- Vomiting
- Transient drops in blood pressure
- Joint pain
In children under 5, rash is also common.
More serious considerations include:
- Low blood pressure, which is managed by ensuring the child has eaten and had fluids before the dose
Sources: FDA prescribing information for Voxzogo; the phase 3 vosoritide trial (Savarirayan et al., The Lancet, 2020, DOI: 10.1016/S0140-6736(20)31541-5), indexed on PubMed. This document is educational and does not constitute medical advice.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
approved (PDF)
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