Drugs / ATV-1601
last change Jul 2026 re-read 9 days ago

ATV-1601

targets AKT1 via inhibition

Developed for
hereditary hemorrhagic telangiectasia · breast cancer
Investigated by
Atavistik Bio, Inc

Trials 2

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT07038369 Jul 2025 → Aug 2028 expected cervical carcinoma, endometrial carcinoma, estrogen-receptor positive breast cancer, fallopian tube cancer +3 Atavistik Bio, Inc Active not recruiting No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT07601425 Jul 2026 → Dec 2027 expected hereditary hemorrhagic telangiectasia Atavistik Bio, Inc Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2026-06-09 Atavistik Bio, Inc Regulatory Atavistik Bio Announces U.S. FDA Clearance of Investigational New Drug Application and Fast Track Designation for ATV-1601 for the Treatment of Hereditary Hemorrhagic Telangiectasia (HHT) atavistikbio.com ↗
The FDA’s clearance of the Harmony-HHT Phase 1/2 study design allows Atavistik Bio to leverage existing clinical data with ATV-1601 and proceed directly into a randomized study.

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as ATV-1601 ClinicalTrials.gov intervention name — accepted as the source's own label NCT07038369 ↗
1

NCT07601425 ↗

Action Inhibit “Selective AKT1 E17K Allosteric Inhibitor” NCT07038369 ↗
Route Oral “ATV-1601 administered orally” NCT07038369 ↗
Target AKT1 “Selective AKT1 E17K Allosteric Inhibitor” NCT07038369 ↗