Drugs / Navenibart
last change Sep 2026 re-read 3 minutes ago

Navenibart

also known as STAR-0215

Monoclonal antibody

Developed for
hereditary angioedema
Investigated by
Astria Therapeutics, Inc.

Trials 6

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT07635095 Apr → Sep 2026 overdue — Astria Therapeutics, Inc. Recruiting No outcome recorded
Phase 1 NCT05477160 Jul 2022 → Nov 2023 hereditary angioedema Astria Therapeutics, Inc. Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT05695248 Feb 2023 → Mar 2025 hereditary angioedema Astria Therapeutics, Inc. Completed No outcome recorded
Phase 21 trial
Phase 2 NCT06007677 Sep 2023 → Mar 2031 expected hereditary angioedema Astria Therapeutics, Inc. Active not recruiting No outcome recorded
Phase 32 trials
Phase 3 NCT07204938 Oct 2025 → Jun 2031 expected hereditary angioedema Astria Therapeutics, Inc. Enrolling by invitation No outcome recorded
Phase 3 NCT06842823 Mar 2025 → Dec 2026 expected hereditary angioedema Astria Therapeutics, Inc. Active not recruiting No outcome recorded

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 7 sources stand behind the page.

FieldValueCited text
Known as navenibart “Navenibart (STAR-0215) is a monoclonal antibody inhibitor of plasma kallikrein modified to extend circulating half-life and is under investigation for HAE prophylaxis.” PMID 40158724 ↗ Mar 2025
4

“Navenibart administered subcutaneously via autoinjector” NCT07635095 ↗

NCT07204938 ↗

NCT05695248 ↗

NCT06842823 ↗

Known as STAR-0215 ClinicalTrials.gov intervention name — accepted as the source's own label NCT06007677 ↗
1

NCT05477160 ↗

Action Inhibit “inhibitor of plasma kallikrein” PMID 40158724 ↗ Mar 2025
Modality Monoclonal antibody “monoclonal antibody” PMID 40158724 ↗ Mar 2025
Route Subcutaneous “STAR-0215 will be administered as an SC bolus injection.” NCT05477160 ↗