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Yuviwel

(Navepegritide)

Phase 2Peptide

Ascendis Pharma

Yuviwel is one of 12 small molecule programs targeting Achondroplasia. It is currently in Phase 2.

1

Indications

2

Total Trials

2

Active Trials

11

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

11

Patents

Pipeline

Status by Indication[3][1]

Indication

AchondroplasiaActive, not recruiting

AchondroplasiaPhase 2

Active, not recruiting

Competition

Competitive Landscape

22 competitors in Achondroplasia

#DrugCompanyPhaseTrials

Recombinant Human Growth Hormone

Changchun GeneScience Pharmaceutical Co., Ltd.

BMN 333

BioMarin Pharmaceutical

Voxzogo

BioMarin Pharmaceutical

Truseltiq

HHelsinn Healthcare SA

TYRA-300

TTyra Biosciences, Inc

Yuviwel

Ascendis Pharma

SAR442501

Recifercept

Infigratinib /kg

QQED Therapeutics, a BridgeBio company

Genotropin

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 2Recruiting

Achondroplasia

NCT06732895

Q4 2028

Phase 2Recruiting

Achondroplasia

NCT06079398

Clinical

Trials by Indication[1]

Achondroplasia2 trials

A Clinical Trial to Evaluate Efficacy and Safety of Navepegritide in Adolescents (12 - 18 Years of Age) With Achondroplasia.

Recruiting·AAscendis Pharma A/S·Phase 2·NCT06732895·24 enrolled

A Clinical Trial to Evaluate Efficacy and Safety of TransCon CNP Compared With Placebo in Infants (0 to <2 Years of Age) With Achondroplasia

Recruiting·AAscendis Pharma A/S·Phase 2·NCT06079398·72 enrolled

Regulatory

FDA Approval Timeline[4]

Feb 27, 2026

YUVIWEL

NDA NDA219164

Sources

References

[1]
ClinicalTrials.gov — 2 trial records for Navepegritide. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Navepegritide compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Navepegritide. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA219164). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Yuviwel. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Ascendis Pharma company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Peptide[2]
Highest Phase: Phase 2[1]
Company: Ascendis Pharma

Patent Landscape[5]

Patent Cliff

Jan 5, 2037

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11413351Jan 5, 2037

12239689Jan 5, 2037

12156917Jan 5, 2037

10835578Jan 5, 2037

11154593Jan 5, 2037

6 more patents

12083182Jan 5, 2037

11311604Jan 5, 2037

11389511Jan 5, 2037

11224661Jan 5, 2037

11389510Jan 5, 2037

12377133Nov 12, 2042

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