QUTENZA (capsaicin)
QUTENZA is indicated for the treatment of Neuropathic Pain; Postherpetic Neuralgia; Diabetic Peripheral Neuropathy.
How QUTENZA Works
Capsaicin acts as an agonist for the transient receptor potential vanilloid 1 (TRPV1) receptor, an ion channel-receptor complex located on pain-sensing nerve fibers in the skin. Topical administration initially stimulates these cutaneous nociceptors, which may be associated with painful sensations. This process is followed by pain relief mediated by a reduction in TRPV1-expressing nerve endings, which lasts until the nerve fibers eventually reinnervate the treated area.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2009-11-16
- Patent Cliff
- 2030
- Routes
- TOPICAL
- Dosage Forms
- PATCH
QUTENZA Approval History
What QUTENZA Treats
3 indicationsQUTENZA is approved for 3 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Neuropathic Pain
- Postherpetic Neuralgia
- Diabetic Peripheral Neuropathy
QUTENZA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to QUTENZA
3 of 8FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
30 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03794388 CAPTRANE results posted | ICO-A-2018-10 | Ph 3 | completed | Evaluation in the Treatment of Neuropathic Pain Post Breast Surgery |
| NCT05840562 CAPNEUCHIM | ICO-2022-02 | Ph 3 | recruiting | Capsaicin 179 mg Patch Versus Oral Duloxetine in Patients With Chemotherapy-induced Peripheral Neuropathy |
| NCT06809569 | 0000-420 MK-0000-420 | Ph 1 | completed | A Study to Evaluate Laser Speckle Contrast Imaging to Assess Changes in Chemical Agent-Induced Skin Blood Flow in Healthy Participants (MK-0000-420) |
| NCT04283292 | 21957 | Ph 4 | completed | Capsaicin for the Treatment of Cannabinoid Hyperemesis Syndrome |
| NCT05298202 results posted | 0192-22-FB | Ph 4 | completed | The Influence of Capsaicin Gel During Exercise Within the Heat |
| NCT01393795 | CRO1824 | Ph 2 | completed | Qutenza®-Remodulin® in Pulmonary Arterial Hypertension Patients |
| NCT05543837 CCPA | 2022-E-20 | Ph 2 | completed | Capsaicin for Cerebral Perfusion Augmentation |
| NCT04918069 CapCIN | 11995 | Ph 2 | completed | Capsaicin to Prevent Delayed Chemotherapy Induced Nausea and Vomiting (CapCIN) |
| NCT03317613 CAPSONCO | 2017-0304 2017-002476-11 | Ph 2 | completed | Clinical Trial Assessing the Efficacy of Capsaicin Patch (Qutenza®) in Cancer Patients With Neuropathic Pain |
| NCT05029297 | ITHUEC-CAP/10-5 | Ph 3 | completed | Study With Two Capsaicin Topic Treatments in Diabetic Neuropathy. |
| NCT00771511 | AAAD5899 | Ph 4 | withdrawn | Cervical Capsaicin for Labor Induction and Pain Relief |
| NCT02288156 results posted | TBM | Ph 4 | completed | Elaboration of Patient-friendly Treatment Strategy With Capsaicin Nasal Spray in Patients With Idiopathic Rhinitis |
| NCT03122145 results posted | IRB201700132 - A | Ph 1, Ph 2 | completed | Normal Breathing and Swallowing in Healthy Volunteers |
| NCT04545892 | Cap1 | Ph 1 | completed | Capsaicin for Cerebral Perfusion Augmentation. |
| NCT02493257 results posted | HSC-MS-14-0173 | Ph 2 | completed | Intranasal Capsaicin Treatment for Non-Allergic Irritant Rhinitis |
| NCT02700815 results posted | 1358.1 2015-000404-25 | Ph 3 | completed | Capsaicin + Diclofenac Gel in Acute Back Pain or Neck Pain |
| NCT03472677 | CNTX-4975i-OA-101 | Ph 1 | completed | The Effect of Injection Site Cooling on Pain Experienced After the Administration of CNTX-4975-05 Into the Knee |
| NCT03576508 | CNTX-4975i-OA-102 | Ph 1 | completed | A Study to Compare Levels of Capsaicin After Intra-Articular Injection and Topical Application in Patients With Painful Knee Osteoarthritis |
| NCT00655811 results posted | 00003739 | Ph 4 | completed | Ethnic Differences in Response to Topical Capsaicin: A Psychophysical Study on Healthy Subjects |
| NCT01713426 ELEVATE | QTZ-EC-0004 2011-005872-41 | Ph 4 | completed | A Study to Compare QUTENZA With Pregabalin for the Treatment of Peripheral Neuropathic Pain (PNP) After 8 Weeks of Treatment |
| NCT01416116 LIFT | QTZ-EC-0002 2010-023258-34 | Ph 4 | completed | Method of Pre-treatment for Application of QUTENZA Capsaicin 8% Patch |
| NCT01252160 STRIDE | E05-CL-3001 2009-016457-18 | Ph 4 | completed | Safety and Effectiveness of Repeated Administration of QUTENZA Patches for Treatment of Pain Caused by Nerve Damage |
| NCT02183519 results posted | IRB201400477 | Ph 1, Ph 2 | completed | Respiratory Kinematics of Cough in Healthy Older Adults and Parkinson's Disease |
| NCT00795106 | 08-1014.01 | Ph 2 | withdrawn | Trial to Evaluate the Efficacy of Topical Capsaicin to Reduce Pain and Improve Health-related Quality of Life in Adults With Chronic Myofascial Neck Pain |
| NCT02695745 | VND1004 2011-002399-18 | Ph 1 | completed | Experimental Biomarker Study for Pain Thresholds |
| NCT01478607 PACE | E05-CL-3002 2009-016458-42 | Ph 3 | completed | A Study to Evaluate the Long-term Safety of Repeated QUTENZA Administration for Treatment of Pain Caused by Nerve Damage in Diabetic Patients |
| NCT01231750 TOPCAP results posted | UC 060559 | Ph 3 | terminated | Efficacy of Topical Capsaicin Cream for Stable Angina |
| NCT01862523 | mucosal potentials in the nose | Ph 4 | completed | Mechanisms of Capsaicin Treatment in Idiopathic Rhinitis Patients and Controls |
| NCT00993070 | MTU-I-1-45/52 | Ph 2, Ph 3 | completed | Efficacy and Safety Study of Topical Capsaicin in Painful Diabetic Neuropathy |
| NCT01223820 | Nasal Capsaicin treatment | Ph 4 | completed | Neuro-immunological Analysis of Idiopathic Rhinitis Patients and Controls Treated With Capsaicin. |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
QUTENZA FDA Label Details
Indications & Usage
FDA Label (PDF)QUTENZA is indicated for the treatment of Neuropathic Pain; Postherpetic Neuralgia; Diabetic Peripheral Neuropathy.
Pro Intelligence Preview
Deep insights for QUTENZA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2030
- • 2 active patents
Trial Analysis
- • 31 total trials
- • Stage: Declining
Competitive Landscape
- • 8 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment