Drugs / OBI-902
last change Dec 2025 re-read 3 minutes ago

OBI-902

Developed for
neoplasm
Investigated by
OBI Pharma, Inc

Trials 1

2026202720282029
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/2 NCT07124117 Aug 2025 → Feb 2029 expected neoplasm OBI Pharma, Inc Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 4

DateIssuerRelease
2025-12-05 OBI Pharma, Inc Regulatory OBI-902 Receives Consecutive FDA Orphan Drug Designation Indication Expanded to Gastric Cancer Including Gastroesophageal Junction Adenocarcinoma obipharma.com ↗
OBI Pharma Inc. (4174.TWO) announced that its proprietarily developed TROP2-targeted antibody-drug conjugate (ADC), OBI-902, has received another Orphan Drug Designation (ODD) from the United States Food and Drug Administration (US FDA).
2025-11-16 OBI Pharma, Inc Regulatory OBI-902 has been granted by US FDA for Orphan Drug Designation for the Treatment of Cholangiocarcinoma. obipharma.com ↗
OBI Pharma, a clinical-stage oncology company (4174.TWO) received notification from the US FDA stating that the request for Orphan Drug Designation of OBI-902 TROP2 ADC for the treatment of Cholangiocarcinoma has been granted.
2025-05-01 OBI Pharma, Inc Regulatory OBI Pharma Announces U.S. FDA Clearance of IND Application for a Phase 1/2 Study of OBI-902, a Trop-2 Targeting ADC obipharma.com ↗
OBI Pharma, Inc. (“OBI”), a clinical stage oncology company (4174.TWO), today announced that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for OBI-902, to conduct a Phase 1/2 study.
2025-04-23 OBI Pharma, Inc Results OBI Pharma Announces Poster Presentations at the AACR 2025 Annual Meeting for OBI-992 and OBI-902 Antibody-Drug Conjugates (ADCs), GlycOBI® and ThiOBI® ADC enabling technologies, the OBI-3424 prodrug, and Globo H (GH) science. obipharma.com ↗
OBI-902 demonstrated superior antitumor activity and favorable PK/PD properties compared to benchmark TROP2 ADCs across various animal models.

Evidence & citations 1 cited value

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

FieldValueCited text
Known as OBI-902 ClinicalTrials.gov intervention name — accepted as the source's own label NCT07124117 ↗