Drugs / ATI-1013

Trials 1

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1 NCT07215923 Oct 2025 → Jun 2026 overdue thromboangiitis obliterans Antidote Therapeutics, Inc Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2018-09-05 Antidote Therapeutics, Inc Regulatory Antidote Therapeutics Receives Orphan Drug Designation for ATI-1013 for the Treatment of Buerger’s Disease antidotetx.com ↗
Antidote Therapeutics, Inc., a biopharmaceutical company developing novel nicotine-blocking therapies to treat diseases caused or worsened by nicotine, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for ATI-1013, a fully human, anti-nicotine monoclonal antibody for the treatment of Buerger’s Disease.

All press releases naming this drug 2 releases

DateIssuerRelease

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as ATI-1013 ClinicalTrials.gov intervention name — accepted as the source's own label NCT07215923 ↗
Modality Monoclonal antibody “a Human Monoclonal Antibody to Nicotine” NCT07215923 ↗
Route Intravenous “Each participant will receive one intravenous (IV) infusion of ATI-1013 or placebo (Day 1).” NCT07215923 ↗