Who are SIROLIMUS's main competitors?

Direct comparators (same drug class / molecular target / therapeutic area): Afinitor, Torisel, Rapamune, Everolimus+Tacrolimus+Prednisone, CsA+Rapamune+CS, Neoral/Sirolimus.

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Last reviewed 2026-05-14 · How we verify

SIROLIMUS — Competitive Intelligence Brief

SIROLIMUS (SIROLIMUS) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: mTOR Inhibitor Immunosuppressant [EPC].

marketed mTOR Inhibitor Immunosuppressant [EPC] mTOR Small molecule Live · refreshed every 30 min

Target snapshot

SIROLIMUS (SIROLIMUS). Sirolimus binds to FKBP-12 to form a complex that inhibits mTOR, blocking T-cell proliferation and antibody production.

Comparator set (6 drugs)

Auto-detected by same drug class / molecular target / therapeutic area, ranked by phase + recency. Override with ?vs=slug1,slug2,….

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
SIROLIMUS TARGET	SIROLIMUS		marketed	mTOR Inhibitor Immunosuppressant [EPC]	mTOR	1999-01-01
Afinitor	everolimus	Novartis	marketed	Kinase Inhibitor [EPC]	Serine/threonine-protein kinase mTOR	2009-01-01
Torisel	temsirolimus	Pfizer	marketed	Kinase Inhibitor	Serine/threonine-protein kinase mTOR	2007-01-01
Rapamune	sirolimus	Pfizer	marketed	mTOR Inhibitor Immunosuppressant [EPC]	Serine/threonine-protein kinase mTOR	1999-01-01
Everolimus+Tacrolimus+Prednisone	Everolimus+Tacrolimus+Prednisone	Fundação Pró Rim	marketed	Immunosuppressive combination therapy	mTOR (everolimus), calcineurin (tacrolimus), glucocorticoid receptor (prednisone)
CsA+Rapamune+CS	CsA+Rapamune+CS	Pfizer	marketed	Immunosuppressive combination therapy	Calcineurin, mTOR, glucocorticoid receptor
Neoral/Sirolimus	Neoral/Sirolimus	University of Miami	marketed	Calcineurin inhibitor + mTOR inhibitor combination	Calcineurin (cyclosporine); mTOR kinase (sirolimus)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

2028-07-01 — Afinitor · 9006224 · Method of Use · US
2029-02-14 — Rapamune · 8911786 · Formulation · US
2030-04-15 — Rapamune · 10206887 · Formulation · US
2036-03-05 — Rapamune · 12061183 · Formulation · US
2036-03-05 — Rapamune · 10705070 · Formulation · US
2036-06-29 — Rapamune · 10973806 · Method of Use · US
2036-06-29 — Rapamune · 12133844 · Method of Use · US
2040-10-28 — Rapamune · 11497737 · Formulation · US

Sponsor landscape (mTOR Inhibitor Immunosuppressant [EPC] class)

· 1 drug in this class
Pfizer · 1 drug in this class

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Cite this brief

Drug Landscape (2026). SIROLIMUS — Competitive Intelligence Brief. https://druglandscape.com/ci/chembl-chembl413. Accessed 2026-05-14.

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