FDA Approved Growth Hormone Axis

Navepegritide

also known as: Yuviwel, TransCon CNP, ACP-015

The weekly achondroplasia treatment — a PEGylated CNP prodrug approved in 2026 that provides continuous growth plate stimulation with once-weekly dosing.

A PEGylated prodrug of CNP using Ascendis Pharma's TransCon technology that provides sustained CNP exposure over a weekly dosing interval, FDA-approved February 2026 for achondroplasia in children >=2 years with open epiphyses.

Mechanism of action

Prodrug that releases unmodified CNP continuously over one week. Released CNP binds NPR-B on growth plate chondrocytes, inhibiting the overactive FGFR3-MAPK pathway in achondroplasia. Same MOA as vosoritide but with sustained weekly exposure.

Primary uses

Achondroplasia in children >=2 years (FDA-approved 2026)
Once-weekly alternative to daily vosoritide

Typical dosing

varies by weight band mcg/kg once weekly (subcutaneous)

Reconstituted from lyophilized powder. Weight-banded dosing.

Regulatory status

FDA-approved February 27, 2026 as Yuviwel under Accelerated Approval for children >=2 years with achondroplasia and open epiphyses. Developed by Ascendis Pharma.

References

[review] Ascendis Pharma. Yuviwel (navepegritide) Prescribing Information. FDA, February 2026.

Related peptides

Vosoritide

The first drug approved for achondroplasia — a CNP analog that stimulates endochondral bone growth by counteracting overactive FGFR3 signaling.

CNP

The third natriuretic peptide — a vascular and skeletal growth factor whose analog vosoritide (Voxzogo) is FDA-approved for achondroplasia, and the endogenous cartilage growth signal.

Somatropin (HGH)

FDA-approved recombinant human growth hormone — the direct hormone replacement, with multiple clinical indications, prescription-only status, and specific federal criminal provisions against off-label distribution.

Lonapegsomatropin

Ascendis Pharma's once-weekly growth hormone prodrug (Skytrofa) — the first weekly GH to receive FDA approval (August 2021) for pediatric GH deficiency in patients aged 1+ years weighing at least 11.5 kg.

Guides & tools

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Disclaimer

This entry is for educational purposes only and does not constitute medical advice. Dosing information reflects published regulatory or research data and is not a recommendation. Many compounds described here are not approved for human use in the United States. Consult a licensed medical professional before considering any peptide therapy.