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Label indication 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 2–4 months after transplantation ( 1.1 ).
Also known as Rapamune
Sirolimus · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Sirolimus tablets 2 mg | EXPERIMENTAL | Sirolimus tablets 2 mg of Dr. Reddys Laboratories Limited |
| Rapamune | ACTIVE_COMPARATOR | Rapamune® 2 mg tablets of Wyeth Laboratories, Philadelphia |
| Name | Type | Description |
|---|---|---|
| Sirolimus | DRUG | Sirolimus tablets 2 mg |
Inclusion Criteria: i. Provide written informed consent ii. Must be healthy, adult, human beings within 18 and 45 years of age (both inclusive) weighing at least 50 kg iii. Having a body mass index between 18.0 and 24.9 (both inclusive), calculated as weight in Kg/height in m2 iv. Must be of nor...
Sirolimus is a small molecule drug being developed by Dr. Reddy's Laboratories Ltd under the ticker RDY. It is in Phase 1 clinical development. The specific therapeutic indication for this program has not been disclosed, and the drug is classified under the Other therapeutic area.
Sirolimus targets FKBP1A and acts as an inhibitor of this target. FKBP1A, also known as FK506-binding protein 1A, is the molecular target through which the drug exerts its inhibitory activity. This mechanism underlies the drug's pharmacological profile as a small molecule inhibitor.
Sirolimus is being developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company is the sponsor of the clinical development program for this small molecule drug candidate.
Sirolimus is in Phase 1 clinical development. Both of its recorded trials are Phase 1 studies, and both have been completed. The drug is investigational and is not approved for any indication based on the available development information.
Sirolimus has been studied in two completed Phase 1 trials: NCT02296762, a bioavailability study of 2 mg tablets under fed conditions with 36 participants, and NCT02296749, a bioavailability study of 2 mg tablets under fasting conditions with 60 participants. Both enrolled healthy volunteers in India.
Sirolimus is the generic name of the active ingredient also marketed under the brand name Rapamune. The Dr. Reddy's Laboratories program referenced here is a separate development effort for sirolimus tablets, distinct from the branded product.