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.

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.