Overview
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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/02/05 | Phase 1 | Completed | |||
2025/02/04 | Phase 2 | Recruiting | |||
2024/12/20 | Early Phase 1 | Not yet recruiting | |||
2024/08/06 | N/A | ENROLLING_BY_INVITATION | |||
2024/07/10 | N/A | Not yet recruiting | |||
2024/06/06 | Phase 4 | Recruiting | University Hospital, Clermont-Ferrand | ||
2023/09/05 | Phase 3 | Recruiting | |||
2023/08/18 | Phase 3 | Recruiting | |||
2023/08/09 | N/A | Not yet recruiting | |||
2023/05/03 | Phase 3 | Recruiting | Institut Cancerologie de l'Ouest |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Pharmaceutica North America, Inc. | 45861-005 | TOPICAL | 0.6 g in 120 g | 10/27/2011 | |
| Koolcare Technology Co., Ltd. | 84205-001 | TOPICAL | 0.25 mg in 1 g | 12/30/2024 | |
| Home Aide Diagnostics, Inc. | 69379-037 | TOPICAL | .0375 g in 100 g | 12/2/2014 | |
| Home Aide Diagnostics, Inc. | 69379-001 | TOPICAL | 0.0375 g in 100 g | 7/8/2015 | |
| Two Hip Consulting, LLC | 76074-152 | TOPICAL | .0355 g in 100 mL | 1/30/2019 | |
| BIO-SANTEE CHEM | 69490-020 | TOPICAL | 0.0375 g in 1 1 | 1/15/2015 | |
| Home Aide Diagnostics, Inc. | 69379-013 | TOPICAL | 0.0357 g in 100 g | 7/7/2015 | |
| Original Patch Company Inc | 69650-002 | TOPICAL | .00375 1 in 100 g | 3/31/2015 | |
| Better Pain Solutions, LLC | 69592-001 | TOPICAL | 0.0375 g in 10 g | 3/19/2015 | |
| Nationwide Pharmaceutical LLC | 69375-006 | TOPICAL | 0.1 g in 100 g | 6/9/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 5/15/2009 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| KUGELMANS HERBAL HEAT LINIMENT bottle | 45809 | H.E Kugelman & Co | Medicine | A | 7/21/1993 |
| ZO-RUB HP capsaicin 0.075% w/w cream tube | 198783 | Medicine | A | 6/27/2012 | |
| ZO-RUB OSTEO capsaicin 0.025% w/w cream tube | 198782 | Medicine | A | 6/27/2012 | |
| ZOSTRIX HP capsaicin 0.075%w/w cream tube | 10344 | Medicine | A | 7/4/1991 | |
| ZOSTRIX capsaicin 0.025%w/w cream tube | 19658 | Medicine | A | 10/14/1991 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| CAPSAICIN MILD CREAM | Wex Pharmaceuticals Inc | 02150107 | Cream - Topical | 0.025 % | 3/6/1995 |
| ARTHUR ITIS CREAM | nabtech pharma inc. | 02231231 | Cream - Topical | 0.025 % | 9/2/1997 |
| BENEJOINT | lane labs-usa, inc. | 02239488 | Cream - Topical | 0.025 % | 1/22/1999 |
| ARTHRITIS EXTRA STRENGTH ROLL-ON LOTION | church & dwight canada corp | 02315548 | Lotion - Topical | 0.035 % / W/W | 9/15/2008 |
| CAPSODAN CREAM | odan laboratories ltd | 02231073 | Cream - Topical | 0.05 % | N/A |
| CAPSAICIN REGULAR CREAM | Wex Pharmaceuticals Inc | 02150115 | Cream - Topical | 0.05 % | 3/6/1995 |
| ANTIPHLOGISTINE RUB A-535 CAPSAICIN LIQUID | carter-horner corp. | 02238003 | Liquid - Topical | 0.025 % | 11/23/1998 |
| CAPSAICIN CREAM 0.025% | ferndale laboratories inc. | 02185717 | Cream - Topical | .025 % | 11/28/1996 |
| ARTHRITIS PAIN RELIEF | church & dwight canada corp | 02486725 | Lotion - Topical | 0.035 % / W/W | 10/28/2019 |
| ARTHRICARE FOR WOMEN MULTI-ACTION | del pharmaceutics (canada) inc. | 01935046 | Cream - Topical | 0.025 % | 12/31/1991 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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