Ireland
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Priya Life Science Compound trial record
Compound · clinical trials

Navepegritide clinical trials

Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 2 trials in our Ireland, UK, France, Denmark, Canada, USA, Germany, Italy, Sweden, Austria, Norway, Portugal and Australia registers that name Navepegritide as an intervention. Synced 10 Nov 2026
2Current trials
1Recruiting now
1Lead sponsor
13Country registers
At a glance

Navepegritide is named as an intervention in 2 current clinical trials in our Ireland, UK, France, Denmark, Canada, USA, Germany, Italy, Sweden, Austria, Norway, Portugal and Australia registers. 1 is recruiting patients now. All registered phases are Phase 2. The lead sponsor is Ascendis Pharma A/S. The most-studied condition is Achondroplasia.

Where Navepegritide is approved

All regulators →

Of the three regulators tracked here, the first to approve Navepegritide was the US, on 27 Feb 2026.

USUnited States (FDA)
27 Feb 2026
Yuviwel
NDA219164 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
No centralised EU authorisation (it may be authorised nationally)
First centralised authorisation
CACanada (Health Canada)
No new-drug Notice of Compliance since 1994
First new-drug NOC

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

Navepegritide patents and exclusivity

Expiry tracker →

Protections still running for marketed products containing Navepegritide, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.

US FDA Orange Book Yuviwel
  • 12 listed patents; the last listed expires 12 Nov 2042 (US 12377133).
  • Latest patent on the drug substance itself: 5 Jan 2037 (US 10835578).
  • Exclusivity ODE-516: Orphan drug exclusivity: to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses, until 27 Feb 2033.
  • Exclusivity NCE: New chemical entity, until 27 Feb 2031.
See the Orange Book listing for NDA 219164

Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.

How Navepegritide works

All drug targets →
  • Agonist at NPR2 Primary target
    Target: NPR2 natriuretic peptide receptor 2
    Guide to Pharmacology only
Other medicines acting on NPR2
Diseases it has been tested for in clinical trials, by furthest phase
  • AchondroplasiaPhase 2/3

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4594507, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 14293, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

Patient leaflets for Navepegritide

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

  • UK
    United Kingdom: Search MHRA Products
    Patient information leaflets and SmPCs for UK-licensed products.
  • US
    United States: Search DailyMed
    FDA-approved labels, including patient and medication guides.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Trials by status

  • Recruiting150%
  • Active, closed150%

Trials by phase

  • Phase 22100%
01

Clinical trials of Navepegritide

2 trials
StudyPhaseStatusLead sponsorRegisters
A Clinical Trial to Evaluate Efficacy and Safety of TransCon CNP Compared With Placebo in Infants (0 to <2 Years of Age) With Achondroplasia
NCT06079398 · Achondroplasia
Phase 2 Recruiting Ascendis Pharma A/S Ireland, UK, USA, Germany, France, Italy, Sweden, Denmark, Austria, Norway, Portugal, Canada, Australia
A Clinical Trial to Evaluate Efficacy and Safety of Navepegritide in Adolescents (12 - 18 Years of Age) With Achondroplasia.
NCT06732895 · Achondroplasia
Phase 2 Active, closed Ascendis Pharma A/S Ireland, UK, France, Denmark, Canada

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Conditions studied with Navepegritide

1 condition
05

Related compounds

06

Questions about Navepegritide trials

How many clinical trials are testing Navepegritide?

2 current trials in our Ireland, UK, France, Denmark, Canada, USA, Germany, Italy, Sweden, Austria, Norway, Portugal and Australia registers name Navepegritide as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.

Are Navepegritide trials recruiting patients?

Yes. 1 of the 2 trials is recruiting: 1 with sites in Ireland, 1 with sites in UK, 1 with sites in France, 1 with sites in Denmark, 1 with sites in Canada, 1 with sites in USA, 1 with sites in Germany, 1 with sites in Italy, 1 with sites in Sweden, 1 with sites in Austria, 1 with sites in Norway, 1 with sites in Portugal and 1 with sites in Australia. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Navepegritide clinical trials?

The lead sponsor is Ascendis Pharma A/S. The number in brackets is how many trials each organisation leads.

Are there Navepegritide clinical trials in Ireland?

Yes. 2 trials in our Ireland register (ClinicalTrials.gov). Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Navepegritide works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Navepegritide works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Navepegritide (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.