Drugs / Serabelisib
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT05300048 | Apr 2022 → Apr 2025 | neoplasm | Faeth Therapeutics | Terminated | No outcome recorded |
| Phase 1 | NCT03154294 | Jul 2017 → Nov 2020 | — | Avera McKennan Hospital & University Health Center | Completed | No outcome recorded |
| Phase 1 | NCT02625259 | Jan → May 2016 | neoplasm | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02551055 | Oct 2015 → Feb 2017 | adenocarcinoma | Millennium Pharmaceuticals, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT01899053 | Jun 2013 → Jan 2017 | neoplasm | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01449370 | Oct 2011 → Jul 2015 | metastatic neoplasm | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT07558733 | Apr 2026 → May 2029 expected | hormone receptor-positive breast cancer | Faeth Therapeutics | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04073680 | Sep 2020 → Jul 2021 | breast cancer, colorectal cancer, endometrial cancer, head and neck cancer +1 | Petra Pharma | Unknown | No outcome recorded |
| Phase 1/2 | NCT02393209 | Jun 2015 → Jan 2017 | non-small cell lung carcinoma | Millennium Pharmaceuticals, Inc. | Terminated | No outcome recorded |
| Phase 24 trials · 2 missed | ||||||
| Phase 2 | NCT06463028 | Dec 2024 → Sep 2028 expected | endometrial cancer | Faeth Therapeutics | Recruiting | No outcome recorded |
| Phase 2 | NCT03193853 | Jul 2017 → Mar 2020 | triple-negative breast carcinoma | Joyce O'Shaughnessy | Completed | No outcome recorded |
| Phase 2 | NCT02724020 | Jun 2016 → Feb 2020 | clear cell renal carcinoma | Millennium Pharmaceuticals, Inc. | Completed | Missed primary |
| Phase 2 | NCT02725268 | Apr 2016 → Jul 2019 | endometrial cancer | Millennium Pharmaceuticals, Inc. | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2026-08-17 | Faeth Therapeutics | Regulatory Faeth Therapeutics Announces FDA Grant of Fast Track Designation for PIKTOR Plus Paclitaxel in Biomarker-Selected Advanced Endometrial Cancer faeththerapeutics.com ↗
Fast Track designation applies to sapanisertib and serabelisib (PIKTOR) in combination with paclitaxel for the treatment of patients with advanced or recurrent endometrial cancer whose tumors harbor a PI3K/AKT/mTOR pathway alteration |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2026-08-17 | Faeth Therapeutics | Faeth Therapeutics Announces FDA Grant of Fast Track Designation for PIKTOR Plus Paclitaxel in Biomarker-Selected Advanced Endometrial Cancer faeththerapeutics.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Serabelisib | “Patients with previously treated advanced solid tumors were eligible for this open label, cohort study of sapanisertib (TAK-228) and serabelisib (TAK-117) with weekly paclitaxel.” PMID 35843739 ↗ Jul 2022 |
| Known as | AGN-PC-0DB6FL | ChEMBL registry synonym — accepted as the source's own label CHEMBL3935857 ↗ |
| Known as | INK1117 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3935857 ↗ |
| Known as | MLN1117 | “Dose Escalation Study of TAK-117 (MLN1117) in Subjects With Advanced Cancer” NCT01449370 ↗ |
| Known as | TAK-117 | “Patients with previously treated advanced solid tumors were eligible for this open label, cohort study of sapanisertib (TAK-228) and serabelisib (TAK-117) with weekly paclitaxel.” PMID 35843739 ↗ Jul 20226“Drug: Tak-228 & Tak-117” NCT03193853 ↗ |
| Action | Inhibit | “PI3-kinase p110-alpha subunit inhibitor” CHEMBL3935857 ↗1“an Oral PI3Kα Inhibitor” NCT01899053 ↗ |
| Modality | Small molecule | “Serabelisib is a selective, small molecule inhibitor of PI3Kα.” NCT07558733 ↗ |
| Route | Oral | “TAK-117 administered once a day orally” NCT01449370 ↗ |
| Target | PIK3CA | “PI3-kinase p110-alpha subunit inhibitor” CHEMBL3935857 ↗ |