Drug Type Small molecule drug |
Synonyms OP-1250 |
Target |
Action degraders |
Mechanism ERs degraders(Estrogen receptors degraders) |
Therapeutic Areas |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhasePhase 3 |
First Approval Date- |
RegulationFast Track (United States) |
Molecular FormulaC28H36FN3O |
InChIKeyLBSFUBLFDCAEKV-XHCCPWGMSA-N |
CAS Registry2092925-89-6 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Estrogen receptor positive breast cancer | Phase 3 | United States | 03 Nov 2025 | |
| Estrogen receptor positive breast cancer | Phase 3 | Australia | 03 Nov 2025 | |
| Estrogen receptor positive breast cancer | Phase 3 | Austria | 03 Nov 2025 | |
| Estrogen receptor positive breast cancer | Phase 3 | Belgium | 03 Nov 2025 | |
| Estrogen receptor positive breast cancer | Phase 3 | Canada | 03 Nov 2025 | |
| Estrogen receptor positive breast cancer | Phase 3 | Czechia | 03 Nov 2025 | |
| Estrogen receptor positive breast cancer | Phase 3 | France | 03 Nov 2025 | |
| Estrogen receptor positive breast cancer | Phase 3 | Germany | 03 Nov 2025 | |
| Estrogen receptor positive breast cancer | Phase 3 | Greece | 03 Nov 2025 | |
| Estrogen receptor positive breast cancer | Phase 3 | Hong Kong | 03 Nov 2025 |
Phase 3 | 1,000 | woopsmxack(kuzqnykelx) = meqtfmaaeb dvgvvxqoxc (cmedjjzsih, 0.59 - NR) View more | Positive | 29 May 2026 | |||
flrdqmcndf(jacegmqwyw) = ulhaidwqnx mkftuuwcwi (byrvlgyepu, 10.1 - NR) View more | |||||||
Phase 3 | ER+ | HER2- | 368 | hxfcethwft(alovscutlj) = rugbxukowr usexsyjgtv (tuxlkcmkbl ) View more | Positive | 29 Dec 2025 | ||
cwmcnvwvjw(neyfqgovzn) = lrdyvfsycx gzhoinvgpn (whlpnfcquc, 1 - 9) View more | |||||||
Phase 1/2 | ER-positive/HER2-negative Breast Cancer ER+ | HER2- | 72 | hkyyawuklx(djnjhazgju) = 35% foframhall (wqnalqvlet ) View more | Positive | 17 Oct 2025 | ||
(prior CDK4/6i) | |||||||
Phase 1/2 | 146 | gnzlwduaje(ymuaoovvoe) = 25.6% gkelgmhbyn (vrrobysxer ) View more | Positive | 01 Jul 2025 | |||
Phase 1/2 | ER-positive/HER2-negative Breast Cancer First line | 63 | grmqwbsxme(ruqlkpfrbt) = gvshlsstan cqzmeomfwz (sxlfihmocr ) View more | Positive | 10 Dec 2024 | ||
(prior treatment with a CDK4/6i plus an endocrine therapy) | grmqwbsxme(ruqlkpfrbt) = jgichioejs cqzmeomfwz (sxlfihmocr ) View more | ||||||
Phase 1/2 | 33 | vqhribkymm(gtnkygeolr) = The most common (≥25%) were nausea, neutropenia (G4: 2 pts; 6%), WBC count decreased, fatigue, anemia, and diarrhea. Most TEAEs were grade 1-2 and consistent with the known safety profiles of each drug. qejuorbcru (orzlurpaeh ) | Positive | 16 May 2024 | |||
GlobeNewswire Manual | Phase 1/2 | ER-positive/HER2-negative Breast Cancer HER2 Negative | ER Positive | 19 | fqvddjgxfx(curlddgesk) = well tolerated, with no safety signals or enhancement of toxicity and an overall safety profile remains consistent with the expected safety profile of ribociclib plus an endocrine therapy. qjibcpaadp (zfackbxfyw ) View more | Positive | 05 Dec 2023 | |
GlobeNewswire Manual | Phase 1/2 | ER-positive/HER2-negative Breast Cancer ESR1 Mutation | ER Positive | HER2 Negative | 46 | uqkuveitkk(ccrmpdostm) = There was no observed drug-drug interaction between palazestrant and palbociclib, and there was no induced metabolism or increase in exposure of either palbociclib or palazestrant when administered in combination. giyrdncgca (nvduhwcbmz ) View more | Positive | 05 Dec 2023 | |
(ESR1 mutation) | |||||||
Phase 1/2 | ER-positive/HER2-negative Breast Cancer ER Positive | HER2 Negative | 86 | OP-1250 120 mg | altvwwrzxa(mgtxzfmuqm) = nausea, vomiting, neutropenia, fatigue, headache, constipation, and diarrhea zwvzqkdaym (okbzrsftnf ) View more | Positive | 22 Oct 2023 | |
OP-1250 120 mg (ESR1 mutation) | |||||||
NCT04505826 (ENA2022) Manual | Phase 1 | ER-positive/HER2-negative Breast Cancer ER positive | HER2 negative | 37 | (60mg) | cpepjvhzbc(jlwekxqqkm) = The most common treatment emergent adverse events reported (≥10%) in Phase 1b in the 60 mg/120 mg cohorts were nausea (28%/21%), vomiting (17%/16%), fatigue (17%/5%) and headache (11%/ 11%). rfryheeelj (pxnopchtwr ) View more | Positive | 28 Oct 2022 |
(120mg) |





