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Sirolimus Tab.
Sirolimus inhibits mTOR (mammalian target of rapamycin), a key signaling protein that controls cell growth and proliferation.
Sirolimus inhibits mTOR (mammalian target of rapamycin), a key signaling protein that controls cell growth and proliferation. Used for Prophylaxis of organ rejection in patients receiving renal transplants, Lymphangioleiomyomatosis (LAM), Tuberous sclerosis complex (TSC)-associated tumors.
At a glance
| Generic name | Sirolimus Tab. |
|---|---|
| Also known as | RaparoBell® Tab. |
| Sponsor | Chong Kun Dang Pharmaceutical |
| Drug class | mTOR inhibitor |
| Target | mTOR (mammalian target of rapamycin) |
| Modality | Small molecule |
| Therapeutic area | Immunology, Oncology |
| Phase | FDA-approved |
Mechanism of action
Sirolimus binds to FKBP12 and forms a complex that inhibits mTOR kinase activity, thereby suppressing T-cell proliferation and reducing immune activation. This mechanism makes it useful as an immunosuppressant to prevent organ rejection and as an antiproliferative agent in certain cancers and vascular diseases.
Approved indications
- Prophylaxis of organ rejection in patients receiving renal transplants
- Lymphangioleiomyomatosis (LAM)
- Tuberous sclerosis complex (TSC)-associated tumors
Common side effects
- Hyperlipidemia
- Thrombocytopenia
- Anemia
- Leukopenia
- Hypertension
- Diarrhea
- Rash
- Mouth ulcers
- Increased creatinine
Key clinical trials
- Combination Therapy (Mirdametinib and Sirolimus) for RAS Mutated Relapsed Refractory Multiple Myeloma (PHASE1, PHASE2)
- Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors (PHASE2, PHASE3)
- Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029) (PHASE2)
- Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms (PHASE2)
- Everolimus Trial in Laryngotracheal Stenosis (EARLY_PHASE1)
- Everolimus in CDK12-Deficient Metastatic Colorectal Cancer (EVER-RECODE) (PHASE1, PHASE2)
- Siplizumab for Sickle Cell Disease Transplant (PHASE1, PHASE2)
- Sirolimus in Combination With Metronomic Chemotherapy in Children With High-Risk Solid Tumors (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Sirolimus Tab. CI brief — competitive landscape report
- Sirolimus Tab. updates RSS · CI watch RSS
- Chong Kun Dang Pharmaceutical portfolio CI