QTORIN 3.9% rapamycin anhydrous gel — Competitive Intelligence Brief

QTORIN 3.9% rapamycin anhydrous gel (QTORIN 3.9% rapamycin anhydrous gel) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: immunosuppressant. Area: Dermatology.

phase 3 immunosuppressant mTOR Dermatology Small molecule

Target snapshot

QTORIN 3.9% rapamycin anhydrous gel (QTORIN 3.9% rapamycin anhydrous gel) — Palvella Therapeutics, Inc.. QTORIN 3.9% rapamycin anhydrous gel is a topical immunomodulator that targets the mTOR pathway.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
QTORIN 3.9% rapamycin anhydrous gel TARGET	QTORIN 3.9% rapamycin anhydrous gel	Palvella Therapeutics, Inc.	phase 3	immunosuppressant	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
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
CsA+Rapamune+CS	CsA+Rapamune+CS	Pfizer	marketed	Immunosuppressive combination therapy	Calcineurin, mTOR, glucocorticoid receptor

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 (immunosuppressant class)

1. Assistance Publique - Hôpitaux de Paris · 1 drug in this class
2. Centre Hospitalier Universitaire, Amiens · 1 drug in this class
3. DH Bio Co., Ltd. · 1 drug in this class
4. Glenmark Pharmaceuticals Ltd. India · 1 drug in this class
5. Palvella Therapeutics, Inc. · 1 drug in this class
6. Pfizer · 1 drug in this class
7. Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan · 1 drug in this class
8. University of California, San Francisco · 1 drug in this class
9. Vanderbilt-Ingram Cancer Center · 1 drug in this class