Growth Signaling

Navepegritide (Yuviwel)

FDA-approved product existsGH axis & hormones
Not yet scored

BioHarmony verdict

Awaiting review

No BioHarmony report yet. It is queued for review; until then, rely on the status and sources below.

What is Navepegritide (Yuviwel)?

FDA granted accelerated approval to Yuviwel (navepegritide) in February 2026 for certain pediatric patients with achondroplasia; continued approval depends on confirmatory evidence.

Dosing as published

Approved labelYUVIWEL prescribing information for pediatric achondroplasia with open epiphyses
PopulationPediatric patients age 2 years and older covered by the accelerated-approval indication
DoseOnce-weekly weight-band doses range from 0.88 mg for 8-9.9 kg to 8.8 mg for 73.6-90 kg; the label table specifies the exact dose, injection volume, and vial strength for nine weight bands.
RouteSubcutaneous injection
FrequencyOnce weekly
DurationUntil confirmation of no further growth potential, with periodic growth and body-weight monitoring
PreparationReconstitute the selected 1.3 mg, 2.8 mg, or 5.5 mg single-dose vial using the entire supplied Sterile Water prefilled syringe. Shake up and down for 15 seconds, let stand 5 minutes, and use within 4 hours at room temperature. Discard unused solution. Patients weighing at least 56 kg require two kits for the labeled injection volume.
Source: Dosage and Administration sections 2.1-2.4; Dosage Forms and Strengths section 3

More reported protocols

Members

Members can compare additional reported doses, schedules, and preparation notes.

Trust & sourcing

US approvalFDA-approved product exists
CompoundingFDA-approved product exists
Last checked2026-07-13
Next review2026-10-11

Primary sources

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