Navepegritide (Yuviwel)_Dosage, benefits & legal status
Also known as Yuviwel, TransCon CNP, TransCon CNP-38, TransCon-C-Type Natriuretic Peptide-38, ACP-015, MN-266
A prodrug that keeps natural-sequence CNP-38 trickling into the blood all week to ease the growth-plate brake behind achondroplasia. In the pivotal trial, children grew 1.49 cm a year faster than on placebo.
Common vial size is what vendors typically sell, not a recommendation. Enter your own vial in the calculator.
What is Navepegritide (Yuviwel)?
Plain language first. The technical label stays, but it never stands alone.Overview
Children with achondroplasia grow slowly because an overactive receptor, FGFR3, acts as a brake on bone lengthening in their growth plates. Navepegritide releases CNP, a natural signal that eases that brake, from a single injection a week. In the 84-child ApproaCH trial, children aged 2 to 11 grew 5.89 cm a year against 4.41 cm on placebo, a difference of 1.49 cm a year. It works only while growth plates are open, and whether it raises final adult height is not yet known; the confirmatory study is due to finish in 2034.
Navepegritide is a prodrug of CNP-38, a peptide with the same 38 residues as human C-type natriuretic peptide (prepro-CNP 89 to 126), joined at lysine 26 through Ascendis Pharma's self-cleaving TransCon linker to two branched 20 kDa methoxy-PEG carriers, about 45 kDa in all. The linker breaks at a steady first-order rate, releasing unmodified CNP-38 to activate NPR-B (guanylyl cyclase B) on growth-plate chondrocytes, where cGMP dampens the MAPK signaling driven by the overactive FGFR3 behind achondroplasia. Released CNP has an apparent half-life of 5.3 days, so one injection covers a week; vosoritide, a protease-resistant CNP analog, is injected daily.
What it's used for
A once-weekly injection under the skin for children 2 and older with achondroplasia whose growth plates are still open, to increase how fast they grow. Prescribed by specialists; it has no adult use.
How does Navepegritide (Yuviwel) work?
What it does in the body, and where.Navepegritide is a slow-release carrier for CNP, the body's own signal that keeps growth-plate cartilage dividing.
- 01The growth-plate brakeIn achondroplasia the FGFR3 receptor in growth-plate cartilage is overactive and keeps the MAPK (ERK) pathway switched on, slowing the cell division that lengthens bones. CNP, acting on its receptor NPR-B, pushes the other way.
- 02A carrier that lets go slowlyWhile attached to its PEG carrier the CNP is inactive. The TransCon linker cuts itself at a steady rate, releasing unchanged CNP-38 through the week; released CNP peaks about 24 hours after a dose and has an apparent half-life of 5.3 days.
- 03Easing the brakeReleased CNP binds NPR-B, a receptor that is also an enzyme (guanylyl cyclase B), and raises cGMP inside cartilage cells. cGMP dampens the FGFR3-driven MAPK signal, so the cells multiply and mature again and bones grow longer while the growth plates are open.
A schematic of the compound's mechanism, not a diagnostic image.
What else is it used for?
Each group carries its own evidence level.Approved means regulators have cleared it for that purpose. Investigational means it is in trials. Early research means it is being studied and is not established.
Pivotal trial (ApproaCH)
FDA-approved- Human trial84 children aged 2 to 11: 5.89 against 4.41 cm/year at week 52, a difference of 1.49 cm/year (95% CI 1.05 to 1.93); 1.0 cm/year under age 5 and 1.8 cm/year from age 5.
- No dataOfficially a phase 2b trial; the registry lists it as phase 2/3, and the FDA treated it as pivotal.
Dose finding (ACcomplisH)
peer-reviewed-human- Human trial57 prepubertal children aged 2 to 10 on 6, 20, 50 or 100 mcg/kg weekly or placebo: 5.42 against 4.35 cm/year at 100 mcg/kg (11 children against 15 on placebo; p=0.0218), with smaller dose-dependent effects at lower doses.
- Human trialNo grade 3 or 4 events and no symptomatic hypotension; 11 injection-site reactions in 8 children.
Infants (reACHin)
Investigational- human-early7 infants, mean age 11.7 months, on 100 mcg/kg weekly: 9.9 cm/year, supine length Z-score up 0.42 and foramen magnum diameter up 3.15 mm at week 52, with no injection-site reactions or symptomatic hypotension.
- No dataUncontrolled sentinel cohort; the randomized part is ongoing.
With weekly growth hormone (COACH)
Investigational- human-early21 children (22 enrolled per the registry) on navepegritide plus lonapegsomatropin: 8.69 cm/year at week 52 in the 12 treatment-naive children against 5.95 cm/year in matched ApproaCH children on navepegritide alone (difference 2.74); later company data gave 7.73 and 7.67 cm/year at week 78 in the treatment-naive and experienced groups.
- No dataOpen-label and single-arm; the combination is not approved.
What the approval rests on
FDA-approved- RegulatoryAccelerated approval is based on growth velocity; the required study of final adult height is due to finish in September 2034.
The FDA label classes navepegritide as a CNP analog, but structurally it is a prodrug that releases CNP-38 with the natural human sequence, while vosoritide, injected daily rather than weekly, has an altered sequence. It does not raise adult height in people whose growth plates have closed and has no adult use: it works only while growth plates are open, and whether it increases final adult height is not yet established, with the confirmatory study the FDA requires due in 2034. The pivotal ApproaCH trial is often quoted as phase 3; it is officially phase 2b, though the registry lists phase 2/3. The gain is often quoted as about 1.5 cm a year; the published figure is 1.49 cm a year (95% CI 1.05 to 1.93), a faster growth rate over one year, not extra centimeters of final height. The European step is reported as an authorization on October 15, 2026: the CHMP gave a positive opinion at its October 12 to 15 meeting, Ascendis announced it on October 16, and the European Commission has yet to decide. Doses written as 0.1 mg/kg and 100 mcg/kg are the same and count only the CNP, not the PEG carrier. The label's low blood pressure warning is drawn from the daily CNP analog; neither ApproaCH nor the dose-finding trial saw symptomatic hypotension.
The published record
Papers and trials about Navepegritide (Yuviwel)
14 papers tagged human · 5 not reviews or lab · 4 clinical trial publications
7 registered trials · 2 with posted results
Furthest stage reached: Approved in the US
Counted from Europe PMC indexing, not read by a person; a human tag can land on reviews, commentary or lab papers; clinical trial publications is the narrower count.
At a glance
Four things to know about Navepegritide (Yuviwel)
Evidence
FDA-approved
Category
Growth hormone
Common vial
Varies
Half-life
About 5.3 days for released CNP (6.7 days for the PEG-bound prodrug)
How much, and do you cycle it?
The range, and whether you take breaks.0.88 to 8.8 mg of CNP once a week by weight band, about 100 mcg/kg (label), once a week. Weekly injections until the growth plates close FDA label
Given every week while the child can still grow; the label says to stop once there is no further growth potential, when the growth plates have closed.
How long does it stay in the body?
The half-life, and where the figure comes from.About 5.3 days for released CNP (6.7 days for the PEG-bound prodrug)FDA label
Predicted steady-state values at 0.1 mg/kg weekly. Released CNP peaks at about 24 hours and the prodrug at about 43 hours; steady state comes after about 3 weekly doses, with accumulation ratios of 1.7 (CNP) and 1.9 (prodrug). Released CNP is broken down like other peptides into small fragments and amino acids. No drug interaction studies; absolute bioavailability not studied.
Source: Yuviwel US prescribing information, section 12.3
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How is it given?
Dosing context and source notes.Supplied as a kit with its own diluent, and the label sets the volume, so there is nothing to work out here.
Label dose: 100 mcg/kg per week. Yuviwel US prescribing information (DailyMed), sections 2 and 16
One injection under the skin once a week, at a fixed dose for each band of actual body weight, counted as CNP content only, not the PEG carrier: from 0.88 mg at 8 to 9.9 kg up to 8.8 mg at 73.6 to 90 kg. The bands follow the trial dose of 100 mcg (0.1 mg) of CNP per kg a week. Doses over 1 mL (6.6 mg and 8.8 mg) use two kits injected at different sites. A missed dose can be given up to 2 days late, otherwise it is skipped, with at least 5 days between doses; a child switching from a daily CNP analog starts the day after the last daily dose. Not recommended when kidney function (eGFR) is below 60 mL/min/1.73 m2. Supplied in cartons of 4 kits, each with a 1.3, 2.8 or 5.5 mg powder vial, a prefilled syringe of sterile water to mix it with, and needles and a syringe; kits are refrigerated, can be kept at up to 30°C for up to 6 months, and the mixed solution is used within 4 hours. The dose is set by body weight, so the calculator cannot draw one.
How do you store it?
Before mixing, and after.Follow the storage on the product label.
Navepegritide (Yuviwel) is supplied as a finished product, so its label sets the storage. Pens, prefilled syringes, implants, tablets and ready-made solutions are used as supplied. Kits that include a powder are mixed just before the dose and usually used straight away, not kept for weeks. Many injectable products go in the fridge and must not be frozen, while others are kept at room temperature, so check the pack or ask the pharmacist.
What are the side effects and cautions?
Known cautions and warnings for this compound.Solubility, computed: 32% charged residues, 34% hydrophobic. Water usually sufficient.
A first-pass rule from peptide manufacturers' guidance. It does not account for disulfide bridges, salt form or how the powder was dried, and it predicts what should be easy rather than what will happen in your vial.
Who should avoid it
- None on the US label
- Not recommended when kidney function (eGFR) is below 60 mL/min/1.73 m2
- Not studied in children with significant heart or blood-vessel disease, who were excluded from the trials
- No use once the growth plates have closed: treatment stops when no further growth is possible
- Safety and benefit under age 2 not established; liver impairment not studied
Stop and get help
- Dizziness, unusual tiredness or nausea after a dose, possible signs of low blood pressure that the label asks to be reported
Common effects
- Vomiting 21% against 14% on placebo (pooled double-blind trials, 68 against 42 children)
- Injection-site reactions 19% against 14%; in two-year ApproaCH data they were all mild, at 0.35 per person-year
- Pain in an arm or leg 12% against 7%, nausea 6% against 0% and excess hair growth (hypertrichosis) 3% against 0%
- Antibodies to the drug in 30% (22 of 73) over up to 3 years, transient and low titer, with no clinical effect identified; whether they neutralize the drug or natural CNP is still being studied
Where this page says nothing is established, that means nobody has studied it, not that a compound is safe.
Is Navepegritide (Yuviwel) approved?
And where the numbers on this page come from.Yes. Navepegritide (Yuviwel) is FDA approved and available on prescription in the United States.
- Approval statusFDA-approved
- RouteUnder the skin (weekly injection)
- Checked17 October 2026
- DoseFrom the drug label. The manufacturer tested this range and a regulator reviewed it.
- Vial sizeFrom what vendors typically list; not a recommendation.
- SourcesYuviwel US prescribing information (FDA, 2026)DailyMed, YuviwelFDA approval letter, NDA 219164Drugs@FDA, NDA 219164Ascendis, orphan drug exclusivity and launch (April 6, 2026)Ascendis, FDA review period extension (November 25, 2025)FDA GSRS substance record, navepegritide (UNII Y3BH8M899D)EMA, CHMP meeting highlights, October 12 to 15, 2026Ascendis, positive CHMP opinion (October 16, 2026)Savarirayan R et al., JAMA Pediatrics 2026;180(1) (ApproaCH)ClinicalTrials.gov, ApproaCH (NCT05598320)Savarirayan R et al., EClinicalMedicine 2023;65:102258 (ACcomplisH)McDonnell CM et al., European Journal of Endocrinology 2026;194(6):745-755 (COACH)Contemporary Pediatrics, reACHin infant data (September 10, 2026)
What has happened recently
The FDA granted orphan designation in February 2019. Ascendis Pharma submitted NDA 219164 on March 31, 2025, with priority review; the PDUFA goal date (the FDA's target date for a decision) of November 30, 2025 moved to February 28, 2026 after the FDA classed a November 5, 2025 submission about a postmarketing requirement as a major amendment. The FDA granted accelerated approval on February 27, 2026, as Yuviwel, a new molecular entity, for children 2 years and older with achondroplasia and open epiphyses, based on improved annualized growth velocity, with a rare pediatric disease priority review voucher and orphan exclusivity through February 27, 2033. Continued approval may depend on a confirmatory open-label, externally controlled study of final adult height due to finish in September 2034, with its final report due in June 2035. In the EU, the European Medicines Agency's medicines committee (CHMP) adopted a positive opinion for Yuviwel in children with achondroplasia at its October 12 to 15, 2026 meeting, announced by Ascendis on October 16; the European Commission decision is pending and expected in the fourth quarter of 2026. VISEN Pharmaceuticals holds the rights in Greater China, where a phase 2 trial has been completed and no approval is established.
You can compare this against the whole library, or read how to check a seller.
What else is like Navepegritide (Yuviwel)?
Others in Growth hormone, side by side.If you're weighing Navepegritide (Yuviwel), it's worth reading Vosoritide (Voxzogo), Ipamorelin, and CJC-1295 with DAC in the same class.
A prodrug that keeps natural-sequence CNP-38 trickling into the blood all week to ease the growth-plate brake behind achondroplasia. In the pivotal trial, children grew 1.49 cm a year faster than on placebo.
- Dose
- 0.88 to 8.8 mg of CNP once a week by weight band, about 100 mcg/kg (label)
- How often
- Once a week
A 39-residue CNP analog with two extra amino acids that resist the enzyme neprilysin, injected once a day while growth plates are open. In the phase 3 trial, children aged 5 to 14 grew 1.57 cm a year faster than on placebo.
- Dose
- 0.096 to 0.8 mg once a day by body weight, from 3 kg up (label)
- How often
- Once a day
A gentle shot that nudges your body to release its own growth hormone.
- Dose
- 0.2 up to 0.3 mg per dose (start low, increase slowly)
- How often
- Daily, often at night
A once-or-twice-weekly shot that keeps your growth hormone raised for days.
- Dose
- 1 up to 2 mg per dose (start low, increase slowly)
- How often
- 1-2x per week
Guides for this compound
- How to Reconstitute a Peptide
Mix peptide powder with bacteriostatic water, step by step.
- How to Read an Insulin Syringe
Read the units, convert to millilitres, and draw the exact dose.
- mcg vs mg: The Peptide Dosing Mistake to Avoid
Your vial says mg and your protocol says mcg. Here is the conversion and how to check it.
Sources
- Yuviwel US prescribing information (FDA, 2026)(2026)Accelerated approval indication; CNP 89 to 126 joined to two branched 20 kDa mPEGs, about 45 kDa; ApproaCH 5.9 against 4.4 cm/year; pooled adverse reactions; apparent half-life 6.7 days (prodrug) and 5.3 days (released CNP).
- DailyMed, Yuviwel(2026)Weight-band doses from 0.88 to 8.8 mg a week; kits with a powder vial and a prefilled diluent syringe; storage and missed-dose rules.
- FDA approval letter, NDA 219164(2026)Accelerated approval February 27, 2026; final adult height study (PMR 4969-1) due September 2034, report June 2035; neutralizing antibody study (PMR 4969-2); rare pediatric disease priority review voucher.
- Drugs@FDA, NDA 219164(2026)Type 1 new molecular entity, priority review, orphan; 1.3, 2.8 and 5.5 mg strengths.
- Ascendis, orphan drug exclusivity and launch (April 6, 2026)(2026)US orphan designation February 2019; orphan exclusivity through February 27, 2033.
- Ascendis, FDA review period extension (November 25, 2025)(2025)A November 5, 2025 submission was classed as a major amendment; the PDUFA date was extended by three months to February 28, 2026.
- FDA GSRS substance record, navepegritide (UNII Y3BH8M899D)(2026)CAS 2413551-27-4; 38-residue CNP sequence, disulfide 22 to 38; one modification at Lys26; codes ACP-015 and TransCon CNP.
- EMA, CHMP meeting highlights, October 12 to 15, 2026(2026)Positive opinion for Yuviwel for achondroplasia in children; designated orphan medicine.
- Ascendis, positive CHMP opinion (October 16, 2026)(2026)Children 2 and older whose epiphyses are not closed; European Commission decision expected in the fourth quarter of 2026; Germany launch planned for early 2027.
- Savarirayan R et al., JAMA Pediatrics 2026;180(1) (ApproaCH)(2025)84 children aged 2 to 11: 5.89 against 4.41 cm/year at week 52, a difference of 1.49 (95% CI 1.05 to 1.93); no serious treatment-related adverse events.
- ClinicalTrials.gov, ApproaCH (NCT05598320)(2026)Officially titled phase 2b, listed as phase 2/3; completed August 13, 2025; results posted July 14, 2026.
- Savarirayan R et al., EClinicalMedicine 2023;65:102258 (ACcomplisH)(2023)57 children on 6 to 100 mcg/kg weekly or placebo: 5.42 against 4.35 cm/year at 100 mcg/kg (p=0.0218); no symptomatic hypotension.
- McDonnell CM et al., European Journal of Endocrinology 2026;194(6):745-755 (COACH)(2026)21 children on navepegritide plus lonapegsomatropin: 8.69 cm/year at week 52 in the 12 treatment-naive children against 5.95 cm/year in matched ApproaCH children on navepegritide alone.
- Contemporary Pediatrics, reACHin infant data (September 10, 2026)(2026)7 infants, mean age 11.7 months: 9.9 cm/year at week 52, without a control group.
Beyond these, 23 records are indexed. Browse the records