Yuviwel (navepegritide)
An approved treatment for Achondroplasia.
The same compound appears under different names depending on the context. Here is how to identify Navepegritide wherever you encounter it, plus the key facts at a glance.
- Generic name
- Navepegritide
- Brand name
- Yuviwel
- Development code
- TransCon CNP
- Drug class
- C-type natriuretic peptide (CNP) analog, long-acting prodrug
- Manufacturer
- Ascendis Pharma
- How it's taken
- Given once a week as an injection under the skin, on the same day each week at any time of day.
A once-weekly injection under the skin that caregivers can give at home after training. It received FDA accelerated approval on February 27, 2026 to increase linear growth in children 2 years and older with achondroplasia whose growth plates are still open. In its main trial, children on Yuviwel grew 5.9 cm in a year against 4.4 cm on placebo, and it is the second drug approved for achondroplasia, after the daily injection Voxzogo (vosoritide) in 2021.
Where Navepegritide fits
The second FDA-approved drug for achondroplasia and the first given once a week. Voxzogo (vosoritide), approved in November 2021, is also a CNP analog but is injected daily and is approved for children of any age with open growth plates. No trial has compared the two.
How Navepegritide works
Achondroplasia is caused by a change in the FGFR3 gene that makes the FGFR3 receptor overactive, and that overactivity slows the growth plates, the zones of cartilage near the ends of long bones where growth happens. CNP is a natural peptide that pushes back against this signal by binding a receptor called NPR-B. Yuviwel is CNP attached to polyethylene glycol (PEG) through a TransCon linker that breaks down steadily in the body, releasing active CNP throughout the week after each injection. The released CNP acts like the body's own CNP, helping cartilage cells in the growth plates multiply and mature, which increases bone growth while the growth plates remain open.
Mechanism: Once-weekly prodrug that steadily releases C-type natriuretic peptide (CNP), which binds the NPR-B receptor and counteracts the overactive FGFR3 signaling that slows bone growth in achondroplasia
Side effects and safety
- Low blood pressure. Brief drops in blood pressure have been reported with a once-daily CNP drug. Call your doctor if your child has dizziness, tiredness or nausea.
- Kidney impairment. Not recommended with moderate or severe kidney impairment (eGFR below 60).
- Growth checked periodically, with the dose adjusted to body weight
- Treatment stops when the growth plates close and no further growth is possible
- Rotate injection sites to lower the risk of skin reactions and local hair growth
Yuviwel has no boxed warning and no contraindications. Its one warning is about low blood pressure: brief drops in blood pressure have been reported with a once-daily CNP drug, and children with significant heart or circulation disease were left out of the trials, so call your doctor if your child has dizziness, tiredness or nausea. In the placebo-controlled parts of 2 trials, side effects on the dose closest to the approved one (0.1 mg/kg a week) and on placebo included vomiting (21% against 14%), injection site reactions such as redness, swelling or bruising (19% against 14%), pain in an arm or leg (12% against 7%) and nausea (6% against 0%). Extra hair growth was reported in 3% against none on placebo, sometimes at injection sites, so injection sites should be rotated. It is not recommended for people with moderate or severe kidney impairment[1].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Navepegritide
Given once a week as an injection under the skin, on the same day each week at any time of day. The dose is based on weight, from 0.88 mg for children weighing 8 to 9.9 kg up to 8.8 mg for those weighing 73.6 to 90 kg, and people weighing 56 kg or more need 2 kits per dose. Caregivers are trained to mix the powder with the prefilled water syringe and inject it into the belly (2 inches from the belly button) or thigh, or, when a caregiver gives it, also the buttocks or back of the upper arm, rotating sites each time. A dose can be given up to 2 days before or after the usual day; if more than 2 days have passed, skip it, and keep at least 5 days between doses. Children switching from a daily CNP drug start Yuviwel the day after their last daily dose. Doctors check growth regularly, adjust the dose by weight and stop treatment once the growth plates close. It is stored in the refrigerator but can be kept at room temperature, up to 30°C, for up to 6 months[1].
Availability and cost
Only available as the brand-name product.
Help paying for Yuviwel
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
Eligible patients with commercial insurance may pay as little as $0 per month for Yuviwel. Not for Medicaid, Medicare, Medigap, VA, DOD or TRICARE beneficiaries or cash-paying patients.
For: private insurance · source - Free medicine program
Uninsured or underinsured patients may qualify for Yuviwel at $0 through the Ascendis Patient Assistance Program.
For: no insurance, underinsured · source - Insurance and case manager help
A Patient Access Liaison helps with insurance coverage, benefits and financial support options, provides injection training support and answers questions about achondroplasia and Yuviwel.
The official page does not say who qualifies. Ask the program. · source
Good to know: Call 8 AM to 8 PM ET, Monday to Friday; choose a language, then press 3 for Yuviwel. Enrollment is through the A.S.A.P consent form. Full copay and PAP terms are in PDFs linked from the page, which were not opened.
- From a charity · Little People of AmericaGrant for Overall Accessible Living (GOAL) fundOpen
Pays for: Mobility devices and occupational tools (partial cost; LPA membership required).
The foundation says: “Applications are being accepted for the GOAL Fund.”
Access and eligibility
Approved for children 2 years and older with achondroplasia whose growth plates (epiphyses) are still open. Safety and effectiveness under age 2 have not been established, and it is not recommended with moderate or severe kidney impairment. The ApproaCH trial enrolled children aged 2 to 12 with genetically confirmed achondroplasia who had not been treated before.
Source: Ascendis Signature Access Program (A.S.A.P)
Access program details are provided for informational purposes and may vary based on insurance coverage, geographic location, and individual circumstances. Confirm current eligibility directly with the manufacturer or your specialty pharmacy.
Clinical trial results
Approval rested on ApproaCH (NCT05598320), which randomly assigned 84 children with achondroplasia aged 2 to 12 (average 5.7 years) who had not been treated before to weekly Yuviwel (57 children) or placebo (27) for 52 weeks. Children on Yuviwel grew an average of 5.9 cm over the year against 4.4 cm on placebo, a difference of 1.5 cm a year, and their height compared with other children with achondroplasia improved by 0.3 standard deviations against no change on placebo. The difference was 1.0 cm a year in children under 5 and 1.8 cm a year in those 5 and older. In an earlier dose-finding trial (NCT04085523) of 57 children, the growth rate held steady in those treated for 2 years at the 0.1 mg/kg weekly dose[1][5]. The ApproaCH results were published in JAMA Pediatrics[4][3].
Development history
Ascendis Pharma developed navepegritide as TransCon CNP. It submitted its application on March 31, 2025; a major amendment in November 2025 extended the review by 3 months, and the FDA granted accelerated approval on February 27, 2026, along with a rare pediatric disease priority review voucher[2][3]. Accelerated approval was based on faster yearly growth, and the FDA requires a confirmatory trial measuring the effect on final adult height, with disproportion (the length of the limbs compared with the trunk) as a secondary measure[2]. Voxzogo (vosoritide), the first achondroplasia drug, was approved on November 19, 2021[7].
Explore Achondroplasia trials
Common questions about Navepegritide
▸What is Navepegritide (Yuviwel)?
A once-weekly injection under the skin that caregivers can give at home after training. It received FDA accelerated approval on February 27, 2026 to increase linear growth in children 2 years and older with achondroplasia whose growth plates are still open. In its main trial, children on Yuviwel grew 5.9 cm in a year against 4.4 cm on placebo, and it is the second drug approved for achondroplasia, after the daily injection Voxzogo (vosoritide) in 2021.
▸How does Navepegritide work?
Achondroplasia is caused by a change in the FGFR3 gene that makes the FGFR3 receptor overactive, and that overactivity slows the growth plates, the zones of cartilage near the ends of long bones where growth happens. CNP is a natural peptide that pushes back against this signal by binding a receptor called NPR-B. Yuviwel is CNP attached to polyethylene glycol (PEG) through a TransCon linker that breaks down steadily in the body, releasing active CNP throughout the week after each injection. The released CNP acts like the body's own CNP, helping cartilage cells in the growth plates multiply and mature, which increases bone growth while the growth plates remain open.
▸What are the side effects of Navepegritide?
Yuviwel has no boxed warning and no contraindications. Its one warning is about low blood pressure: brief drops in blood pressure have been reported with a once-daily CNP drug, and children with significant heart or circulation disease were left out of the trials, so call your doctor if your child has dizziness, tiredness or nausea. In the placebo-controlled parts of 2 trials, side effects on the dose closest to the approved one (0.1 mg/kg a week) and on placebo included vomiting (21% against 14%), injection site reactions such as redness, swelling or bruising (19% against 14%), pain in an arm or leg (12% against 7%) and nausea (6% against 0%). Extra hair growth was reported in 3% against none on placebo, sometimes at injection sites, so injection sites should be rotated. It is not recommended for people with moderate or severe kidney impairment[1].
▸How is Navepegritide taken?
Given once a week as an injection under the skin, on the same day each week at any time of day. The dose is based on weight, from 0.88 mg for children weighing 8 to 9.9 kg up to 8.8 mg for those weighing 73.6 to 90 kg, and people weighing 56 kg or more need 2 kits per dose. Caregivers are trained to mix the powder with the prefilled water syringe and inject it into the belly (2 inches from the belly button) or thigh, or, when a caregiver gives it, also the buttocks or back of the upper arm, rotating sites each time. A dose can be given up to 2 days before or after the usual day; if more than 2 days have passed, skip it, and keep at least 5 days between doses. Children switching from a daily CNP drug start Yuviwel the day after their last daily dose. Doctors check growth regularly, adjust the dose by weight and stop treatment once the growth plates close. It is stored in the refrigerator but can be kept at room temperature, up to 30°C, for up to 6 months[1].
▸Is Navepegritide FDA approved?
Yes, Navepegritide (Yuviwel) is FDA approved (2026) for the treatment of Achondroplasia.
▸What is the difference between Yuviwel and Voxzogo?
Both are CNP analogs that counter the overactive FGFR3 signal in achondroplasia. Yuviwel (navepegritide) is injected once a week and is approved from age 2, while Voxzogo (vosoritide) is injected once a day and is approved for children of any age with open growth plates. No trial has compared them, so there is no evidence that one works better than the other.
▸Can my child switch from Voxzogo to Yuviwel?
The Yuviwel label covers switching from a daily CNP drug: start the weekly Yuviwel injection on the day after the last daily dose. Talk with your child's doctor first, since Yuviwel is approved for children 2 and older and the doctor sets the dose by weight.
▸How much extra height does Yuviwel give?
In the ApproaCH trial, children on Yuviwel grew 5.9 cm in a year against 4.4 cm on placebo, about 1.5 cm a year more on average. The FDA approved it based on this growth rate, and a required follow-up trial is measuring the effect on final adult height, which is not yet known.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. National Library of Medicine, DailyMed. YUVIWEL (navepegritide) for injection, for subcutaneous use: prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e01c1197-338f-414c-b804-808e129ebc8c
- U.S. Food and Drug Administration · 2026-02-27. NDA 219164 accelerated approval letter. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/219164Orig1s000ltr.pdf
- Ascendis Pharma · 2026-02-27. FDA Approves Once-Weekly YUVIWEL (navepegritide) for Children with Achondroplasia Aged 2 Years and Older. https://investors.ascendispharma.com/news-releases/news-release-details/fda-approves-once-weekly-yuviwelr-navepegritide-children
- JAMA Pediatrics · 2026. Once-Weekly Navepegritide in Children With Achondroplasia: The ApproaCH Randomized Clinical Trial. https://doi.org/10.1001/jamapediatrics.2025.4771
- ClinicalTrials.gov. A Clinical Trial to Evaluate Efficacy and Safety of TransCon CNP Compared With Placebo in Children With Achondroplasia (ApproaCH). https://clinicaltrials.gov/study/NCT05598320
- U.S. National Library of Medicine, DailyMed. VOXZOGO (vosoritide) for injection, for subcutaneous use: prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=228e8560-04a4-4bb1-a81f-29531a9e4d27
- U.S. Food and Drug Administration. Novel Drug Approvals for 2021. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2021
- Ascendis Pharma. Resources for patients and caregivers: personalized support (A.S.A.P). https://yuviwel.com/support-services/