Capsaicin

Generic Name: Capsaicin

Brand Names: Capzasin Quick Relief, Capzasin-HP, Castiva Warming, Dendracin Neurodendraxcin, Lidopro, Medi-derm, Medi-derm With Lidocaine, Medrox, Qutenza, Rematex, Xoten-C, Zostrix

Drug Type: Small Molecule

Chemical Formula: C_₁₈H_₂₇NO_₃

CAS Number: 404-86-4

Unique Ingredient Identifier: S07O44R1ZM

Background: Capsaicin is most often used as a topical analgesic and exists in many formulations of cream, liquid, and patch preparations of various strengths; however, it may also be found in some dietary supplements. Capsaicin is a naturally-occurring botanical irritant in chili peppers, synthetically derived for pharmaceutical formulations. The most recent capsaicin FDA approval was Qutenza, an 8% capsaicin patch dermal-delivery system, indicated for neuropathic pain associated with post-herpetic neuralgia.

Indication: The capsaicin 8% patch is indicated in the treatment of neuropathic pain associated with post-herpetic neuralgia. There are multiple topical capsaicin formulations available, including creams and solutions, indicated for temporary analgesia in muscle and join pain as well as neuropathic pain.

Associated Conditions: Back Pain Lower Back, Back pain, Bursitis, Contusions, Inflammatory Reaction caused by Rheumatism, Muscle Cramps, Musculoskeletal Pain, Neuropathic Pain, Osteoarthritis (OA), Pain caused by Rheumatism, Periarthritis, Soft Tissue Injury, Tendinitis, Acute nonspecific tenosynovitis, Articular inflammation

Clinical Trials

A Clinical Study to Test Efficacy and Safety of Repeat Doses of CNTX-4975-05 in Patients With Osteoarthritis Knee Pain

Phase 3

Completed

Conditions: Osteoarthritis, Knee

Interventions: Drug: Placebo
Drug: CNTX-4975-05

First Posted Date: 2018-09-07

Last Posted Date: 2022-07-21

Lead Sponsor: Centrexion Therapeutics

Target Recruit Count: 332

Registration Number: NCT03660943

Locations: 🇺🇸
Chase Medical Research, LLC, Waterbury, Connecticut, United States
🇺🇸
Holland Center for Family Health, Glendale, Arizona, United States
🇺🇸
TriWest Research Associates, El Cajon, California, United States

and more 27 locations

An Open-label, 8-week Safety, Efficacy, and Assessment of Cooling Methods for Administration of CNTX-4975-05 for Knee OA

Phase 3

Completed

Conditions: Knee Osteoarthritis

Interventions: Drug: CNTX-4975-05
Drug: Lidocaine without epinephrine
Device: Breg Ice Water Pump
Device: ElastoGel

First Posted Date: 2018-09-07

Last Posted Date: 2022-03-09

Lead Sponsor: Centrexion Therapeutics

Target Recruit Count: 854

Registration Number: NCT03661996

Locations: 🇺🇸
Holland Center for Family Health, Peoria, Arizona, United States
🇺🇸
Chase Medical Research, LLC, Waterbury, Connecticut, United States
🇺🇸
Tandem Clinical Research, Marrero, Louisiana, United States

and more 25 locations

A Mechanistic Evaluation of the Nociceptive Desensitizing Properties of Topical Capsaicin

Not Applicable

Completed

Conditions: Lidocaine
Capsaicin
Ultaviolet B Light Burn
Neuropathic Pain

Interventions: Drug: Capsaicin Topical
Other: Histamine 1%
Radiation: Ultraviolet-B (UVB) irradiation
Drug: Lidocaine

First Posted Date: 2018-07-16

Last Posted Date: 2020-04-20

Lead Sponsor: Aalborg University

Target Recruit Count: 44

Registration Number: NCT03587220

Locations: 🇩🇰
Silvia Lo Vecchio, Aalborg, Nordjylland, Denmark

A Study to Compare Levels of Capsaicin After Intra-Articular Injection and Topical Application in Patients With Painful Knee Osteoarthritis

Phase 1

Completed

Conditions: Knee Osteoarthritis

Interventions: Drug: CNTX-4975-05
Drug: Qutenza
Drug: Lidocaine (without epinephrine)

First Posted Date: 2018-07-03

Last Posted Date: 2018-11-14

Lead Sponsor: Centrexion Therapeutics

Target Recruit Count: 16

Registration Number: NCT03576508

Locations: 🇺🇸
Well Pharma Medical Research, Corp, Miami, Florida, United States

A Phase 2 Clinical Trial Examining the Effects on Osteoarthritic Knee Pain of CGS-200-1, CGS-200-5 and Vehicle Control

Phase 2

Completed

Conditions: Osteoarthritis, Knee
Pain

Interventions: Drug: CGS-200-1
Drug: CGS-200 Vehicle
Drug: CGS-200-5

First Posted Date: 2018-05-17

Last Posted Date: 2024-10-30

Lead Sponsor: Propella Therapeutics

Target Recruit Count: 122

Registration Number: NCT03528369

Locations: 🇺🇸
Clinical Research of West Florida, Clearwater, Florida, United States
🇺🇸
CTI Clinical Research Center, Cincinnati, Ohio, United States
🇺🇸
Radiant Research, Inc., San Antonio, Texas, United States

and more 2 locations

Pain Biomarker Study

Phase 1

Conditions: Migraine
Trigeminal Autonomic Cephalgia
Hemicrania Continua
Paroxysmal Hemicrania
Short-Lasting Unilateral Neuralgiform Headache with Conjunctival Injection and Tearing
Cluster Headache
SUNCT

Interventions: Drug: Oral capsaicin
Drug: Topical capsaicin
Drug: Intranasal capsaicin
Other: Cold Water Irrigation
Other: Medical Air
Drug: Low Flow Oxygen
Drug: High Flow Oxygen

First Posted Date: 2018-04-30

Last Posted Date: 2025-01-14

Lead Sponsor: The University of Texas Health Science Center, Houston

Target Recruit Count: 371

Registration Number: NCT03511846

Locations: 🇺🇸
The University of Texas Health Science Center at Houston, Houston, Texas, United States

The Effect of Injection Site Cooling on Pain Experienced After the Administration of CNTX-4975-05 Into the Knee

Phase 1

Completed

Conditions: Osteoarthritis, Knee

Interventions: Other: Ice Pack and Cooling Device
Drug: CNTX-4975-05 (trans-capsaicin)
Drug: Capsaicin

First Posted Date: 2018-03-21

Last Posted Date: 2018-12-19

Lead Sponsor: Centrexion Therapeutics

Target Recruit Count: 20

Registration Number: NCT03472677

Locations: 🇬🇧
MAC Clinical Research, Manchester, United Kingdom

Spinal and Supra-Spinal Pain Mechanisms in Patients With Fibromyalgia

Completed

Conditions: Fibromyalgia
Pain

Interventions: Other: Vehicle Patch
Drug: Capsaicin Patch 8% or 0.1% Capsaicin Cream

First Posted Date: 2018-03-14

Last Posted Date: 2023-12-14

Lead Sponsor: University of Florida

Target Recruit Count: 55

Registration Number: NCT03464292

Locations: 🇺🇸
University of Florida, Gainesville, Florida, United States

A Phase 3 Efficacy and Safety Study of Intra-articular CNTX-4975-05 (Capsaicin) vs Placebo in Subjects With OA Knee Pain

Phase 3

Completed

Conditions: Osteoarthritis, Knee

Interventions: Drug: Placebo
Drug: CNTX-4975-05

First Posted Date: 2018-02-12

Last Posted Date: 2022-07-26

Lead Sponsor: Centrexion Therapeutics

Target Recruit Count: 332

Registration Number: NCT03429049

Locations: 🇺🇸
Clinical Research Consortium, Las Vegas, Nevada, United States
🇺🇸
Drug Studies America, Marietta, Georgia, United States
🇺🇸
Clinical Investigations of Texas, Plano, Texas, United States

and more 30 locations

Localized Neuropathic Pain: Topical Treatment Versus Systemic Treatment

Phase 4

Terminated

Conditions: Neuropathic Pain

Interventions: Drug: Lidocaine patch 5%
Drug: Capsaicin 8% Patch
Drug: Pregabalin

First Posted Date: 2017-11-21

Last Posted Date: 2021-04-28

Lead Sponsor: University Hospital, Antwerp

Target Recruit Count: 33

Registration Number: NCT03348735

Locations: 🇧🇪
AZ Klina, Brasschaat, Belgium
🇧🇪
UZ Brussel, Jette, Belgium
🇧🇪
Hopital Universitaire Sart Tilman de Liège (ULg) (CHU), Liège, Belgium

and more 10 locations

Drug Development Updates

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