Last reviewed 2026-04-23 · How we verify

Sirolimus Topical Cream

Sirolimus is an mTOR inhibitor that suppresses immune cell proliferation and angiogenesis when applied topically to skin lesions.

Sirolimus is an mTOR inhibitor that suppresses immune cell proliferation and angiogenesis when applied topically to skin lesions. Used for Melanoma (topical treatment), Non-melanoma skin cancer (topical treatment).

At a glance

Mechanism of action

Sirolimus (rapamycin) inhibits the mammalian target of rapamycin (mTOR), a key regulator of cell growth and proliferation. In topical form, it reduces T-cell activation and proliferation while also inhibiting angiogenesis, making it potentially useful for skin cancers and precancerous lesions. The mechanism leverages both immunosuppressive and anti-proliferative effects localized to the treatment site.

Approved indications

• Melanoma (topical treatment)
• Non-melanoma skin cancer (topical treatment)

Common side effects

• Local skin irritation
• Erythema
• Pruritus
• Application site reactions

Key clinical trials

• Daily Topical Rapamycin for Vitiligo (PHASE2)
• Topical Sirolimus in Cutaneous Lymphatic Malformations (PHASE2)
• Topical Rapamycin/Sirolimus for Complicated Vascular Anomalies and Other Susceptible Lesions (PHASE1)
• Topical Sirolimus in Chemoprevention of Facial Squamous Cell Carcinomas in Solid Organ Transplant Recipients (SiroSkin) (PHASE3)
• Dose-Ranging Efficacy and Safety Study of Topical Rapamycin Cream for Facial Angiofibroma Associated With Tuberous Sclerosis Complex (PHASE2, PHASE3)
• Re-administration of Intramuscular AAV9 in Patients With Late-Onset Pompe Disease (PHASE1)
• Safety, Tolerability, and Efficacy Study of CLL442 in Patients With Cutaneous Squamous Cell Carcinoma in Situ (SCCis) (PHASE1)
• Topical Rapamycin to Erase Angiofibromas in TSC (PHASE2)

Primary sources

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