Low-dose sirolimus — Competitive Intelligence Brief

Low-dose sirolimus (Low-dose sirolimus) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: mTOR inhibitor. Area: Immunology.

phase 3 mTOR inhibitor mTOR (mechanistic target of rapamycin) Immunology Small molecule

Target snapshot

Low-dose sirolimus (Low-dose sirolimus) — Icahn School of Medicine at Mount Sinai. Low-dose sirolimus inhibits mTOR signaling to suppress immune cell proliferation and promote regulatory T cell differentiation.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Low-dose sirolimus TARGET	Low-dose sirolimus	Icahn School of Medicine at Mount Sinai	phase 3	mTOR inhibitor	mTOR (mechanistic target of rapamycin)
SIROLIMUS	SIROLIMUS		marketed	mTOR Inhibitor Immunosuppressant [EPC]	mTOR	1999-01-01
Rapamune	sirolimus	Pfizer	marketed	mTOR Inhibitor Immunosuppressant [EPC]	Serine/threonine-protein kinase mTOR	1999-01-01
Percutaneous sirolimus	Percutaneous sirolimus	Children's Hospital of Fudan University	marketed	mTOR inhibitor	mTOR (mechanistic target of rapamycin)
sirolimus (drug), mmf (drug)	sirolimus (drug), mmf (drug)	University Hospital Muenster	marketed	Immunosuppressive agents (mTOR inhibitor + IMPDH inhibitor combination)	mTOR (sirolimus); IMPDH type II (MMF)
Tacrolimus/Sirolimus	Tacrolimus/Sirolimus	University of Miami	marketed	Calcineurin inhibitor and mTOR inhibitor combination	Calcineurin (tacrolimus) and mTOR (sirolimus)
Sirolimus + Maraviroc	Sirolimus + Maraviroc	University of Maryland, Baltimore	marketed	mTOR inhibitor + CCR5 antagonist combination	mTOR; CCR5

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)

• 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 class)

1. Chong Kun Dang Pharmaceutical · 2 drugs in this class
2. Wyeth is now a wholly owned subsidiary of Pfizer · 2 drugs in this class
3. Exelixis · 1 drug in this class
4. GlaxoSmithKline · 1 drug in this class
5. Grupo Espanol de Tumores Neuroendocrinos · 1 drug in this class
6. H. Lee Moffitt Cancer Center and Research Institute · 1 drug in this class
7. Hannover Medical School · 1 drug in this class
8. Hospital do Rim e Hipertensão · 1 drug in this class
9. ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) · 1 drug in this class
10. Melanoma and Skin Cancer Trials Limited · 1 drug in this class