Olomorasib

also known as LY3537982

Developed for: non-small cell lung carcinoma · colorectal neoplasm · biliary tract neoplasm · cancer · endometrium neoplasm · metastatic neoplasm · ovarian neoplasm · pancreatic neoplasm
Investigated by: Eli Lilly and Company · Loxo Oncology, Inc. · AstraZeneca · Janssen Research & Development, LLC · Merck Sharp & Dohme LLC · UNC Lineberger Comprehensive Cancer Center

Trials 17

today NCT07814417 · Ph 2 NCT07794592 · Ph 1 NCT07639242 · Ph 2 NCT07227025 · Ph 1/2 NCT07439250 · Ph 1 NCT07124013 · Ph 1 NCT07137689 · Ph 1 NCT07044271 · Ph 1 NCT06890598 · Ph 3 NCT06719128 · Ph 1 NCT06235983 · Ph 1 NCT06119581 · Ph 3 NCT06111521 · Ph 1 NCT05901311 · Ph 1 NCT05860933 · Ph 1 NCT05824858 · Ph 1 NCT04956640 · Ph 1/2

202220232024202520262027202820292030

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 111 trials
Phase 1	NCT07794592	Aug → Oct 2026 expected	—	Eli Lilly and Company	Recruiting	No outcome recorded
Phase 1	NCT07439250	Mar → Apr 2026	—	Eli Lilly and Company	Completed	No outcome recorded
Phase 1	NCT07124013	Sep 2025 → Jan 2026	—	Eli Lilly and Company	Completed	No outcome recorded
Phase 1	NCT07137689	Aug 2025 → Apr 2026	impaired renal function disease	Eli Lilly and Company	Completed	No outcome recorded
Phase 1	NCT07044271	Jul → Nov 2025	—	Eli Lilly and Company	Completed	No outcome recorded
Phase 1	NCT06719128	Dec 2024 → Aug 2025	liver disorder	Eli Lilly and Company	Completed	No outcome recorded
Phase 1	NCT06235983	Feb 2024 → Jul 2025	cancer	Eli Lilly and Company	Completed	No outcome recorded
Phase 1	NCT06111521	Oct 2023 → Apr 2024	—	Eli Lilly and Company	Completed	No outcome recorded
Phase 1	NCT05901311	Jun → Aug 2023	—	Eli Lilly and Company	Completed	No outcome recorded
Phase 1	NCT05860933	May → Aug 2023	—	Eli Lilly and Company	Completed	No outcome recorded
Phase 1	NCT05824858	Apr → Jun 2023	—	Eli Lilly and Company	Completed	No outcome recorded

Phase 1/22 trials
Phase 1/2	NCT07227025	Mar 2026 → Nov 2028 expected	non-small cell lung carcinoma	Janssen Research & Development, LLC	Recruiting	No outcome recorded
Phase 1/2	NCT04956640	Jul 2021 → Apr 2027 expected	biliary tract neoplasm, colorectal neoplasm, endometrium neoplasm, non-small cell lung carcinoma +2	Eli Lilly and Company	Active not recruiting	No outcome recorded
Phase 22 trials
Phase 2	NCT07814417	Oct 2026 → Nov 2028 expected	colorectal neoplasm	Eli Lilly and Company	Not yet recruiting	No outcome recorded
Phase 2	NCT07639242	Jun 2026 → Jun 2030 expected	non-small cell lung carcinoma	UNC Lineberger Comprehensive Cancer Center	Not yet recruiting	No outcome recorded
Phase 32 trials
Phase 3	NCT06890598	Mar 2025 → May 2029 expected	non-small cell lung carcinoma	Eli Lilly and Company	Recruiting	No outcome recorded
Phase 3	NCT06119581	Dec 2023 → Nov 2027 expected	metastatic neoplasm, non-small cell lung carcinoma	Eli Lilly and Company	Recruiting	No outcome recorded

News releases announcing trial results or a regulatory action · 3

Date	Issuer	Release
2026-08-03	Eli Lilly and Company	Regulatory Lilly's olomorasib receives U.S. FDA's Breakthrough Therapy designation for the treatment of previously treated KRAS G12C-mutant advanced pancreatic cancer lilly.com ↗
2025-09-04	Eli Lilly and Company	Regulatory Lilly's olomorasib receives U.S. FDA's Breakthrough Therapy designation for the treatment of certain newly diagnosed metastatic KRAS G12C-mutant lung cancers lilly.com ↗
2024-06-01	Eli Lilly and Company	Results Updated Data from the Phase 1/2 Study of Olomorasib in KRAS G12C-Mutant Advanced Solid Tumors Presented at the 2024 ASCO® Annual Meeting lilly.com ↗ These data show efficacy with olomorasib across tumor types and, importantly, tolerability that suggests it can be combined with immunotherapy, the backbone of first-line treatment for KRAS-mutant NSCLC.

All press releases naming this drug 3 releases

Date	Issuer	Release
2026-08-03	Eli Lilly and Company	Lilly's olomorasib receives U.S. FDA's Breakthrough Therapy designation for the treatment of previously treated KRAS G12C-mutant advanced pancreatic cancer lilly.com ↗
2025-09-04	Eli Lilly and Company	Lilly's olomorasib receives U.S. FDA's Breakthrough Therapy designation for the treatment of certain newly diagnosed metastatic KRAS G12C-mutant lung cancers lilly.com ↗
2024-06-01	Eli Lilly and Company	Updated Data from the Phase 1/2 Study of Olomorasib in KRAS G12C-Mutant Advanced Solid Tumors Presented at the 2024 ASCO® Annual Meeting lilly.com ↗

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 18 sources stand behind the page.

Field	Value	Cited text
Known as	Olomorasib	ClinicalTrials.gov intervention name — accepted as the source's own label NCT07439250 ↗ 8 NCT07639242 ↗ NCT07227025 ↗ NCT07794592 ↗ NCT06890598 ↗ NCT06719128 ↗ NCT07124013 ↗ NCT07044271 ↗ NCT07814417 ↗
Known as	LY3537982	“A Study of Olomorasib (LY3537982) in Healthy Participants” NCT07439250 ↗ 8 NCT04956640 ↗ NCT05824858 ↗ NCT06235983 ↗ NCT05901311 ↗ NCT06119581 ↗ NCT07137689 ↗ NCT06111521 ↗ NCT05860933 ↗
Modality	Small molecule	— CHEMBL6068410 ↗
Route	Oral	“Oral” NCT04956640 ↗