Sirolimus: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Sirolimus appears in the FDA drug-label database. Marketed as sirolimus.
- Drug class
- mTOR Inhibitor Immunosuppressant; Kinase Inhibitor (FDA established pharmacologic class)
- Mechanism of action
- mTOR Inhibitors; Protein Kinase Inhibitors (as stated on the FDA label)
- Boxed warning
- The FDA label for Sirolimus carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
Sirolimus is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants: Patients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2 months to 4 months after transplantation ( 1.1 ). Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients ( 1.1 , 1.2 , 14.3 ). Sirolimus is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis ( 1.3 ). 1.1 Prophylaxis of Organ Rejection in Renal Transplantation Sirolimus tablets are indicated for the prophylaxis of organ rejection in patients aged 13 years or older receiving renal transplants. In patients at low- to moderate-immunologic risk, it is recommended that sirolimus tablets be used initially in a regimen with cyclosporine and corticosteroids; cyclosporine should be withdrawn 2 to 4 months after transplantation [ see Dosage and Administration ( 2.2 ) ]. In patients at high-immunologic r…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Failed Impurities/Degradation Specifications — Dr. Reddy's Laboratories, Inc. | Class III (FDA: unlikely to cause harm) | Ongoing | 2024-05-01 |
| Failed Impurities/Degradation Specifications — American Health Packaging | Class III (FDA: unlikely to cause harm) | Terminated | 2021-05-12 |
| Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint. — Apotex Corp. | Class III (FDA: unlikely to cause harm) | Terminated | 2022-05-03 |
| Failed impurities/degradation: out of specification result for impurity secorapamycin. — Dr. Reddy's Laboratories, Inc. | Class III (FDA: unlikely to cause harm) | Terminated | 2016-06-03 |
| Failed Stability Specifications — Aadi Bioscience | Class III (FDA: unlikely to cause harm) | Terminated | 2022-10-13 |
Phase breakdown
Conditions being studied
Recruiting trials involving Sirolimus
- 131I-apamistamab-based Conditioning for Hematopoietic Stem Cell Transplant (HSCT) in Advanced Sickle Cell Disease (SCD)
- Allo HSCT for High Risk Hemoglobinopathies
- Cosibelimab for CSCC in Patients With Kidney Transplant or Hematologic Malignancy
- Haploidentical Donor Hematopoietic Cell Transplant for Sickle Cell Disease
- Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metastatic Skin Cancer
- Nonmyeloablative Stem Cell Transplant in Children With Sickle Cell Disease and a Major ABO-Incompatible Matched Sibling Donor
- Phase I/II Study to Reduce Post-transplantation Cyclophosphamide Dosing for Older or Unfit Patients Undergoing Bone Marrow Transplantation for Hematologic Malignancies
- Safety and Durability of Sirolimus for Treatment of LAM
- Sickle Cell Disease Transplant Using a Nonmyeloablative Approach for Patients With Anti-donor Red Cell Antibody
- Sirolimus in Patients With Systemic Lupus Erythematosus-Associated Immune Thrombocytopenia
- Sirolomus Adjuvant Treatment of Focal Refractory Epilepsy (SATFRE)
- Stopping TSC Onset and Progression 2B: Sirolimus TSC Epilepsy Prevention Study
- Study of HLA-Haploidentical Stem Cell Transplantation to Treat Clinically Aggressive Sickle Cell Disease
Common questions
Is Sirolimus FDA-approved?
Yes, marketed as sirolimus. Its FDA label carries a boxed warning.
How many recruiting trials involve Sirolimus?
13 recruiting trials across 15 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.