Treats advanced renal cell carcinoma. Sold as Torisel. Every FDA application for this active ingredient: 1 branded and 2 generic.
As of Nov 14, 2026, FDA lists 3 applications for Temsirolimus (sold as Torisel), first approved May 30, 2007, with 3 new uses approved and 0 published complete response letters.
| Temsirolimus | Part B | $751K | -25% | 76 |
| Temsirolimus | Part D | $21K | New | 0 |
| Effect of Sirolimus on Oocyte Quality in Women Undergoing IVFOocytes, Oocyte Competence · Center for Human Reproduction | Phase 4 | Recruiting | Nov 13, 2026 |
| Phase I/II Trial of Dinutuximab Beta in Combination With Irinotecan and Rapamycin in Pediatric, Adolescents and Adult Patients With Relapsed/Refractory Bone Tumors.Osteosarcomas, Bone Cancer · University Hospital, Strasbourg, France | Phase 1 / Phase 2 | Not yet recruiting | Oct 1, 2026 |
| Low-Dose Sirolimus for the Treatment of RUNX1 Familial Platelet DisorderFamilial Platelet Disorder With Associated Myeloid Malignancy · OHSU Knight Cancer Institute | Phase 1 | Recruiting | Sep 28, 2026 |
| A Study of AL58805 in Advanced, Metastatic GYN, STS or Breast CancersEndometrial Neoplasms, Soft Tissue Sarcoma (STS) · Advenchen Pharmaceuticals, LLC. | Phase 1 / Phase 2 | Not yet recruiting | Sep 10, 2026 |
| A Study of Catequentinib Hydrochloride (AL3818) in Endometrial, LGSOC, STS or GBM CancersEndometrial Neoplasms, Ovarian Neoplasms · Advenchen Pharmaceuticals, LLC. | Phase 1 / Phase 2 | Not yet recruiting | Sep 10, 2026 |
| A Study of Clinical Practice and Real-world Care of Patients Treated With mTOR, PI3K, and MEK Inhibitors for Extracranial Vascular AnomaliesVascular Anomalies · Novartis Pharmaceuticals | — | Not yet recruiting | Aug 17, 2026 |
| Everolimus bAsed caLcineurin inhibiTor frEe immunosuppRession oNe Year AfTer lIver transplantatiON (ALTERNATION)Liver Allograft, Liver Diseases · Hannover Medical School | Phase 3 | Recruiting | Jul 31, 2026 |
| A Phase 1 Study of UB-VV500 With Rapamycin in Relapsed/Refractory Multiple MyelomaMultiple Myeloma in Relapse, Multiple Myeloma (MM) · Umoja Biopharma | Phase 1 | Recruiting | Jul 30, 2026 |
| May 30, 2007 | ToriselNDA 22088 · New molecular entity | Pf Prism Cv | 18 | Marketed |
| Jul 30, 2018 | TemsirolimusANDA 203153 | Accord Hlthcare | 1 | Marketed |
| Aug 16, 2019 | TemsirolimusANDA 207383 | Gland | 0 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Accord Hlthcare