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Navepegritide

Not yet reviewed: Listed from FDA or ClinicalTrials.gov records; an editor has not checked it yetListed from FDA or ClinicalTrials.gov records; an editor has not checked it yet.

Also known as Yuviwel

Ascendis Pharma A/S ASND

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Key figures

  • Next catalyst

    None scheduled

    Only dates with a source are listed

  • Phase

    Approved

    Not recorded

  • Linked trials

    0

    From ClinicalTrials.gov

  • Latest FDA action

    Approved

    NDA219164,

Recalls, shortages, patents and EU status at a glance

Key information

Sponsor
Ascendis Pharma A/S ASND Source: Company record for Ascendis Pharma A/S (opens in a new tab)
Indications
Not recorded
Application
NDA 219164 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 219164 (opens in a new tab)
Designations
None recorded
Next catalyst
None scheduled

Development timeline

  1. Preclinical Completed
  2. Phase 1 Completed
  3. Phase 2 Completed
  4. Phase 3 Completed
  5. Filed Completed
  6. Approved Current stageFirst approval 27 Feb 2026

Overview

Mechanism
Not recorded
Route
Not recorded
Modality
Not recorded
Specialties
Not recorded

Overview text is written by HealthTrade editors.

Key dates

No catalysts yet. Editors add each date together with its source.

FDA designations

No FDA designations are on record for Navepegritide. Editors add each one with its source.

Filed application

No filed application is on record for Navepegritide. Approvals are listed under FDA actions.

FDA advisory committees

No FDA advisory committee meetings are on record for Navepegritide.

Clinical trials

No trials are linked to this drug yet.

Trial quality

About CT-VCA

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FDA actions

Original approvals and new-indication supplements for Navepegritide, newest first
ApplicationActionDateOutcomeReviewSource
NDA219164Action letter for NDA219164 (opens in a new tab) Original 1 Type 1 - New Molecular EntityApprovedpriorityDrugs@FDA via openFDA (opens in a new tab)

Data provided by the U.S. Food and Drug Administration.

FDA recalls load here.

FDA drug shortages load here.

Orange Book patents load here.

FAERS adverse event counts load here.

Papers and preprints load here.

Community discussion loads here.

EU status (EMA)

OpinionOrphan medicine

Yuviwel (EMEA/H/C/006627)

Authorised
Not given
Therapeutic area
Achondroplasia
Marketing authorisation holder
Ascendis Pharma Growth Disorders A/S
Active substance (INN)
Navepegritide
ATC code
M05BX

Matched by active substance: EMA's INN or active substance equals this drug's name.

EMA page for Yuviwel (opens in a new tab)EMA medicine data (opens in a new tab)

Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.

Related news

No recent headlines mention this drug.

Sources

Record updated .

Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.