Rapamycin-calcitriol combination — Competitive Intelligence Brief

Rapamycin-calcitriol combination (Rapamycin-calcitriol combination) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: mTOR inhibitor. Area: Oncology.

phase 3 mTOR inhibitor mTOR Oncology Small molecule

Target snapshot

Rapamycin-calcitriol combination (Rapamycin-calcitriol combination) — National Taiwan University Hospital. Rapamycin-calcitriol combination inhibits the mammalian target of rapamycin (mTOR) and vitamin D receptor (VDR) pathways.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Rapamycin-calcitriol combination TARGET	Rapamycin-calcitriol combination	National Taiwan University Hospital	phase 3	mTOR inhibitor	mTOR
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
SIROLIMUS	SIROLIMUS		marketed	mTOR Inhibitor Immunosuppressant [EPC]	mTOR	1999-01-01
Tacrolimus/Sirolimus	Tacrolimus/Sirolimus	University of Miami	marketed	Calcineurin inhibitor and mTOR inhibitor combination	Calcineurin (tacrolimus) and mTOR (sirolimus)
Afinitor	Afinitor	Central European Society for Anticancer Drug Research	marketed		Multidrug resistance protein 1, Peptidyl-prolyl cis-trans isomerase FKBP1A, Serine/threonine-protein kinase mTOR

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 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