Navepegritide Injection 1.3 mg, 2.8 mg, 5.5 mg Suppliers & Bulk Manufacturers
Available Forms: Powder vial for subcutaneous injection
Available Strengths: 1.3 mg, 2.8 mg, 5.5 mg
Reference Brands: Yuviwel (Ascendis Pharma)
Category: Orphan Drugs
Navepegritide (Yuviwel, Ascendis Pharma) is a once-weekly C-type natriuretic peptide (CNP) prodrug for children with achondroplasia, granted accelerated approval by the US FDA in February 2026. PharmaTradz handles enquiries for authorised supply of the originator product (named-patient and import-permit orders), and connects developers and licensees preparing for patent and exclusivity expiry.
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Product Description:
Achondroplasia, the most common form of short-limbed dwarfism, is caused by an overactive FGFR3 receptor that slows bone growth at the growth plates. C-type natriuretic peptide (CNP) counteracts that signal. Navepegritide is a long-acting prodrug that releases CNP steadily over a week, using Ascendis's TransCon technology, so it is injected once a week rather than daily like vosoritide.
The US FDA granted navepegritide accelerated approval as Yuviwel in February 2026 to increase linear growth in children aged 2 and over with achondroplasia whose growth plates are still open. It is given as a weekly subcutaneous injection, with the dose set by body weight from 1.3 mg, 2.8 mg and 5.5 mg vials.
Sourcing and licensing notes. Navepegritide is patented and made only by Ascendis Pharma; there is no generic. We confirm registration status for each destination before quoting.
How Navepegritide Injection is supplied today, and licensing ahead of patent expiry
Where navepegritide is approved
Checked 3 Oct 2026| Market | Status | Brand · regulator · date |
|---|---|---|
| United States | Approved | Yuviwel · FDA · Feb 2026 (accelerated) |
| Generic / biosimilar | None | None approved as of the check date |
Not approved in your country? A hospital or doctor can often still import it for a named patient, through a special-access, import-permit or compassionate-use route. We confirm which route applies in your country and the documents needed before quoting. Ask about named-patient supply →
Frequently Asked Questions
Increasing growth in children aged 2 and over with achondroplasia whose growth plates are still open.
Yuviwel, from Ascendis Pharma. The US FDA granted accelerated approval in February 2026.
Both act through the CNP pathway. Navepegritide is injected once a week; vosoritide is injected daily.
No. It is patented. We handle authorised-supply enquiries and connect developers and licensees preparing for patent expiry.
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