capsaicin

Trade name: qutenza

Small moleculeapprovedOrphan Drug ^FDA

Approved

Nov 16, 2009

Capsaicin (8-methyl-N-vanillyl-6-nonenamide) is an active component of chili peppers, which are plants belonging to the genus Capsicum. It is a potent irritant for mammals, including humans, for which it produces a sensation of burning in any tissue with which it comes into contact. Capsaicin and several related amides (capsaicinoids) are produced as secondary metabolites by chili peppers, likely as deterrents against eating by mammals and against the growth of fungi. Pure capsaicin is a hydrophobic, colorless, highly pungent crystalline solid. — Wikipedia

Clinical trial activity

181 trials · 137 clinical orgs · 2 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Jun 1, 1995 (NCT00004316)

Timeline

1990s

Jan 1, 1995
Earliest Phase 1 Sponsor(trial)
Jan 1, 1998
Earliest Phase 3 Sponsor(trial)

2000s

Jan 1, 2001
Earliest Phase 2 Sponsor(trial)
May 22, 2009
Orphan Drug Designation
Nov 16, 2009
NeurogesX — Earliest FDA Approval
Nov 16, 2009
Averitas Pharma — NDA Secondary Org
Nov 16, 2009
NeurogesX — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Vanilloid receptorOPENER
TRPV1 opener
- Transient receptor potential cation channel subfamily V member 1 (TRPV1) ↗

Approval history

approvedNov 16, 2009

Chemistry & pharmacology

Loading structure…

SMILES

COc1cc(CNC(=O)CCCC/C=C/C(C)C)ccc1O

Mol. weight: 305.42 g/mol
Lipinski Ro5: Pass
Rule of 3: No
Chirality: Single Stereoisomer
Inorganic: No
Polymer: No
Availability: Prescription Only

Oral

Parenteral

Topical

Sources

Also known as

6,7-deepoxy-6,7-didehydro-5-deoxy-21-dephenyl-21-(phenylmethyl)daphnetoxin 20-(3-hydroxy-5-methoxybenzeneacetate)
capsaicin
capsaicin
capsaicin
capsaicin
capsaicin
capsaicin
capsaicin
capsaicin
capsaicin
capsaicin
capsaicin
capsaicin
capsaicine
capsaicum
capsicum
capsicum
capsicum
capsicum
caspaicin
cntx-4975
(e)-8-methyl-n-vanillyl-6-nonenamide
(e)-8-methyl-n-vanillyl-6-nonenamide
fiery jack
isodecenoic acid vanillylamide
isodecenoic acid vanillylamide
ngx 4010
ngx-4010
qutenza
qutenza
qutenza
qutenza
reciniferatoxin
reciniferatoxin
resiniferatoxin
resiniferatoxin
resiniferatoxin
rtx diterpene
trans-8-methyl-n-vanillyl-6-nonenamide
trans-8-methyl-n-vanillyl-6-nonenamide
zacin
zacin
zostrix
zostrix
zostrix hp
zostrix hp

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT07260656	Early Phase 1 (Phase 1)	Dec 31, 2025	Virginia Polytechnic Institute and State University
NCT07122973	N/A	Sep 17, 2025	Aalborg University
NCT06960759	Phase 2	Aug 1, 2025	Emory University, University of Colorado, Denver, University of Melbourne, University of Montana
NCT07060976	N/A	Jul 21, 2025	Novamed Laboratories Pvt. Ltd., NovoBliss Research Pvt Ltd
NCT06744816	Early Phase 1 (Phase 1)	Jun 5, 2025	Averitas Pharma, University of Texas at Houston
NCT06807164	Phase 2	Feb 1, 2025	Ligue contre le cancer, France, University of Lille
NCT06444919	Phase 4	Sep 1, 2024	Grunenthal, University Clermont Auvergne
NCT06444594	Early Phase 1 (Phase 1)	Jun 15, 2024	Pennsylvania State University
NCT05695339	Phase 1	Jan 3, 2024	National Institutes of Health (NIH)
NCT05997979	Phase 2	Dec 1, 2023	University of Western Brittany
NCT06197529	N/A	Nov 21, 2023	Aalborg University
NCT06023706	Phase 3	Nov 15, 2023	University of Nantes
NCT05840562	Phase 3	Sep 30, 2023	Grunenthal, Institut de Cancerologie de l'Ouest Paul Papin
NCT06809569	Phase 1	Sep 25, 2023	Merck
NCT05835258	N/A	May 30, 2023	Eurecat
NCT05649228	Early Phase 1 (Phase 1)	Dec 31, 2022	Virginia Polytechnic Institute and State University
NCT05560516	N/A	Oct 1, 2022	Leiden University, University of Amsterdam
NCT05543837	Phase 2	Sep 20, 2022	Centenario Hospital Miguel Hidalgo, Instituto Mexicano del Seguro Social, Torre Medica CMQ
NCT05298202	Phase 4	Apr 1, 2022	University of Nebraska
NCT05067257	Phase 2	Dec 31, 2021	Sorrento Therapeutics, Inc.

Showing 20 of 181 trials

Page 1 / 10

Organizations

Research & Development (137)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
NeurogesX	For profit	17	17	3	2002
Centrexion Therapeutics	For profit	10	10	3	2007
Aalborg University	Academic/Hospital	9	9	2	2016
University of Florida	Academic/Hospital	9	9	3	2013
Sorrento Therapeutics, Inc.	For profit	8	7	3	2008
Astellas	For profit	6	5	2	2010
AlgoRx Pharmaceuticals	For profit	5	5	1	2004
Hospital de Mataró	Academic/Hospital	5	5	2	2012
University of Copenhagen	Academic/Hospital	5	4	3	2004
Anesiva, Inc.	For profit	4	3	2	2007
Katholieke Universiteit Leuven	Academic/Hospital	4	3	2	2011
University of Texas at Houston	Academic/Hospital	4	4	3	2014
Grunenthal	For profit	3	0	2	2019
National Institute of Dental and Craniofacial Research (NIDCR)	Government	3	3	2	2001
University of Toronto	Academic/Hospital	3	3	3	2014
Wake Forest University	Academic/Hospital	3	3	2	2006
American Academy of Otolaryngic Allergy	Academic/Hospital	2	0	2	2014
Averitas Pharma	For profit	2	1	2	2021
Bassett Healthcare	Academic/Hospital	2	2	1	2013
Boehringer Ingelheim	For profit	2	2	2	2016

137 organizations

Page 1 / 7

Marketing (2)

Organization	Org type	Relationship	Date
Averitas Pharma	For profit	NDA2	Nov 16, 2009
NeurogesX	For profit	NDA	Nov 16, 2009