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Last Updated: June 14, 2025

CLINICAL TRIALS PROFILE FOR CAPSAICIN


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505(b)(2) Clinical Trials for Capsaicin

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT02346903 ↗ Chest Pain Perception and Capsaicin Sensitivity Completed Bassett Healthcare N/A 2013-04-01 The purpose of this study is to determine whether there is a positive correlation between the ability to sense chest pain in the context of myocardial ischemia and the ability to sense discomfort associated with the topical application of the TRPV1 agonist capsaicin (the active ingredient on hot chili peppers). Patients undergoing clinical elective balloon angioplasty of a coronary stenosis will be asked to quantify the subjective intensity of any chest pain they feel during a standardized episode of myocardial ischemia produced by a one-minute coronary balloon occlusion, using a previously-validated numeric rating scale. The same patients will subsequently be asked to grade the subjective intensity of cutaneous discomfort resulting from application of a capsaicin-containing patch (Capzasin-HP Cream, an over-the-counter product approved for topical application to treat muscle and joint aches) to the forearm. The goal will be to determine whether an association can be demonstrated between the subjective perception of ischemic chest pain during coronary balloon occlusion and cutaneous capsaicin sensitivity. Such an association could have considerable clinical value, as it might allow physicians to prospectively assess an individual's ability to perceive myocardial ischemia/infarction by assessing his/her subjective response to the topical application of capsaicin.
OTC NCT03124407 ↗ Osteoarthritis Knee Pain Relief Study of 0.25% 920-CGS-200 Completed Palm Beach CRO Phase 4 2016-07-01 This is a study of an over-the-counter, capsaicin-based (0.25%) topical analgesic for management of osteoarthritis knee pain meeting the US Food and Drug Administration's (FDAs) Tentative Final Monograph (TFM) guidance for "External Analgesic Drug Products For Over-the-Counter Human Use," published in the Federal Register on February 8, 1983 (final proposed 21 CFR 348). Subjects meeting the inclusion criteria and not meeting the exclusion criteria were randomized into one of four groups: once daily treatment with active product, once daily treatment with product vehicle (no capsaicin), twice daily treatment with active product, and twice daily treatment with product vehicle (no capsaicin), all for 7 consecutive days of treatment. The twice daily treatments were spaced approximately 12 hours apart. Osteoarthritis knee pain was assessed by the 100 mm visual analog scale. Osteoarthritis knee pain assessments were done each day for 28 days. Tolerability data were also collected.
OTC NCT03124407 ↗ Osteoarthritis Knee Pain Relief Study of 0.25% 920-CGS-200 Completed Palm Beach Research, Inc Phase 4 2016-07-01 This is a study of an over-the-counter, capsaicin-based (0.25%) topical analgesic for management of osteoarthritis knee pain meeting the US Food and Drug Administration's (FDAs) Tentative Final Monograph (TFM) guidance for "External Analgesic Drug Products For Over-the-Counter Human Use," published in the Federal Register on February 8, 1983 (final proposed 21 CFR 348). Subjects meeting the inclusion criteria and not meeting the exclusion criteria were randomized into one of four groups: once daily treatment with active product, once daily treatment with product vehicle (no capsaicin), twice daily treatment with active product, and twice daily treatment with product vehicle (no capsaicin), all for 7 consecutive days of treatment. The twice daily treatments were spaced approximately 12 hours apart. Osteoarthritis knee pain was assessed by the 100 mm visual analog scale. Osteoarthritis knee pain assessments were done each day for 28 days. Tolerability data were also collected.
OTC NCT03124407 ↗ Osteoarthritis Knee Pain Relief Study of 0.25% 920-CGS-200 Completed Propella Therapeutics Phase 4 2016-07-01 This is a study of an over-the-counter, capsaicin-based (0.25%) topical analgesic for management of osteoarthritis knee pain meeting the US Food and Drug Administration's (FDAs) Tentative Final Monograph (TFM) guidance for "External Analgesic Drug Products For Over-the-Counter Human Use," published in the Federal Register on February 8, 1983 (final proposed 21 CFR 348). Subjects meeting the inclusion criteria and not meeting the exclusion criteria were randomized into one of four groups: once daily treatment with active product, once daily treatment with product vehicle (no capsaicin), twice daily treatment with active product, and twice daily treatment with product vehicle (no capsaicin), all for 7 consecutive days of treatment. The twice daily treatments were spaced approximately 12 hours apart. Osteoarthritis knee pain was assessed by the 100 mm visual analog scale. Osteoarthritis knee pain assessments were done each day for 28 days. Tolerability data were also collected.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Capsaicin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00001307 ↗ Positron Emission Tomography to Measure Pain and Pain Control Completed National Institute of Dental and Craniofacial Research (NIDCR) 1992-08-01 This study will examine how the brain processes pain signals and how the different parts of the brain work with each other in response to painful stimuli. A better understanding of how people experience pain may be helpful in developing more effective treatments. Healthy normal volunteers, patients requiring third molar (wisdom tooth) extraction, and patients with persistent pain due to disease, injury or other reason may be eligible for this study. Participants will receive one or more of the following sensory stimuli, which may cause brief discomfort or pain: - Heat/Cold - applied by an electronically controlled device that touches the skin, or by temperature-controlled water baths, or by a thermally controlled brass cylinder the subject grasps - Capsaicin (active ingredient in hot chili peppers) - injected in a small volume of fluid under the skin or into a muscle - Mechanical stimulation - brushings or vibrations that do not normally cause pain - Ischemic stimulation - inflation of a blood pressure cuff on the arm or leg for up to 30 minutes These stimuli will be applied both before and during positron emission tomography (PET) scanning. This test shows which parts of the brain are active and which are not and is important for studying how different parts of the brain work together to feel and react to specific sensations. For this procedure, the subject lies on a table in the PET scanner while a series of scans are taken during different sensory conditions. At the beginning of each scan, radioactive water is injected into an arm vein through a catheter (a thin plastic tube). A special camera records the arrival and disappearance of the radiation in various brain areas, creating a picture of the brain's activity in various regions. Oral surgery patients may have PET scans both before and after their wisdom tooth extraction. Alfentanil, a commonly used narcotic pain reliever, will also be given during the PET procedure to determine how the brain responds to sensory stimuli while under the effects of a pain killer. Participants will also have a magnetic resonance imaging (MRI) scan of the brain to help interpret the PET results. MRI uses a magnetic field and radio waves to show structural and chemical changes in tissues. During the scan, the subject lies on a table in a cylindrical machine (the scanner). He or she can speak with a staff member via an intercom system. Some sensory studies may require placing an arterial and/or intravenous line. Following injection of a local anesthetic, a catheter is placed in an artery in the arm. At regular intervals during various sensory stimuli, small blood samples are drawn from the artery to measure blood gases and other substances. Samples may also be drawn from a catheter placed in a vein. Subjects may also have ultrasound monitoring to evaluate blood flow in the arteries, veins and brain. A gel is spread over the skin above the blood vessel and a hand-foot-and-mouth device is placed on the gel. The device emits high-frequency sound waves to produce a picture of the speed of blood flow in the artery and the diameter of the vessel.
NCT00004316 ↗ Phase I/II Randomized, Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar Vestibulitis Completed University of Pittsburgh Phase 1/Phase 2 1995-06-01 OBJECTIVES: I. Estimate the optimal safe dose of intravesical capsaicin in patients with interstitial cystitis. II. Evaluate the efficacy of 0.025% topical capsaicin in relieving chronic burning pain in patients with vulvar vestibulitis. III. Evaluate the effect of capsaicin on type C nerve fibers in bladder mucosa and vulvar skin. IV. Evaluate the effect of C fiber depletion on urinary levels of histamine and prostaglandin.
NCT00004316 ↗ Phase I/II Randomized, Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar Vestibulitis Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 1/Phase 2 1995-06-01 OBJECTIVES: I. Estimate the optimal safe dose of intravesical capsaicin in patients with interstitial cystitis. II. Evaluate the efficacy of 0.025% topical capsaicin in relieving chronic burning pain in patients with vulvar vestibulitis. III. Evaluate the effect of capsaicin on type C nerve fibers in bladder mucosa and vulvar skin. IV. Evaluate the effect of C fiber depletion on urinary levels of histamine and prostaglandin.
NCT00008476 ↗ Capsaicin to Control Pain Following Third Molar Extraction Completed National Institute of Dental and Craniofacial Research (NIDCR) Phase 2 2001-01-01 This study will test the effectiveness of the drug capsaicin in controlling pain after third molar (wisdom tooth) extraction. Capsaicin, the ingredient in chili peppers that makes them "hot," belongs to a class of drugs called vanilloids, which have been found to temporarily inactivate pain-sensing nerves. Healthy normal volunteers between 16 and 40 years of age who require third molar (wisdom tooth) extraction may be eligible for this study. Participants will undergo the following procedures in three visits: Visit 1: Patients will have touch (sensory) testing by the following three methods: 1) a warm sensor applied to the gums and the patient will rate when they first feel heat and when the heat feels painful; 2) the bristles of a small paint brush will be gently stroked across the gums, and the patient will say whether it feels painful; 3) a light touch will be applied to the gums with a small needle, and the patient will rate the pain intensity following the touch. After testing, patients will be numbed with a local anesthetic (bupivacaine) and then capsaicin or placebo (an inactive solution) will be injected next to the tooth. The tooth then will be extracted one day later. Visit 2: Patients will return to the clinic after 24 hours to repeat the same type of sensory testing. After testing, patients will be sedated and numbed with a local anesthetic (lidocaine) and given an intravenous injection of either saline or ketorolac (30 mg). After the extraction, pain ratings will be recorded every 20 minutes, for up to 6 hours. During this time, patients will be monitored for numbness, pain, side effects and vital signs (heart rate, blood pressure, respiration, etc.). Those who request pain medicine will receive acetaminophen and codeine. Patients will be required to stay for up to 3 more hours after this and then they will then be discharged with pain medicine. Visit 3: Patients will return to the clinic after another 48 hours to repeat the same sensory testing. Remaining wisdom teeth will be removed "off-study" at least three weeks following the first visit.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Capsaicin

Condition Name

Condition Name for Capsaicin
Intervention Trials
Pain 33
Healthy 16
Neuropathic Pain 13
Cough 10
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Condition MeSH

Condition MeSH for Capsaicin
Intervention Trials
Neuralgia 30
Cough 16
Osteoarthritis 13
Osteoarthritis, Knee 12
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Clinical Trial Locations for Capsaicin

Trials by Country

Trials by Country for Capsaicin
Location Trials
United States 167
United Kingdom 24
Denmark 16
Belgium 14
France 10
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Trials by US State

Trials by US State for Capsaicin
Location Trials
Florida 22
New York 13
California 12
North Carolina 11
Texas 11
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Clinical Trial Progress for Capsaicin

Clinical Trial Phase

Clinical Trial Phase for Capsaicin
Clinical Trial Phase Trials
Phase 4 28
Phase 3 17
Phase 2/Phase 3 8
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Clinical Trial Status

Clinical Trial Status for Capsaicin
Clinical Trial Phase Trials
Completed 125
Recruiting 22
Unknown status 20
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Clinical Trial Sponsors for Capsaicin

Sponsor Name

Sponsor Name for Capsaicin
Sponsor Trials
NeurogesX 12
University of Florida 10
Aalborg University 7
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Sponsor Type

Sponsor Type for Capsaicin
Sponsor Trials
Other 176
Industry 84
NIH 17
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Capsaicin: Clinical Trials, Market Analysis, and Projections

Introduction to Capsaicin

Capsaicin, the active component of chili peppers, has been increasingly recognized for its versatile applications, particularly in the pharmaceutical, food, and cosmetic industries. Its analgesic, pain-relieving, and anti-inflammatory properties make it a valuable ingredient in various products.

Current Clinical Trials: QUTENZA (Capsaicin 8% Topical System)

A significant development in the clinical trials landscape involves QUTENZA, a capsaicin 8% topical system. Averitas Pharma, Inc., the U.S. subsidiary of GrĂ¼nenthal, has completed recruitment for the Phase III clinical trial AV001. This trial aims to evaluate the efficacy, safety, and tolerability of QUTENZA in treating post-surgical neuropathic pain (PSNP), a condition affecting approximately 10% of all surgical procedures, impacting over 3 million people in the U.S. annually[1][4].

Trial Details

  • Trial Design: The AV001 trial is a double-blind, randomized study involving 410 patients with moderate to severe PSNP for at least six months. The trial spans 42 weeks.
  • Primary Endpoint: The primary endpoint is a decrease in average pain intensity at the 12-week mark compared to baseline measurements.
  • Future Implications: Successful completion of this trial could lead to an expanded indication for QUTENZA in the U.S. market, providing a non-opioid therapy option for a large, underserved patient population[1][4].

Market Analysis of Capsaicin

The capsaicin market is experiencing significant growth driven by several factors.

Market Size and Growth

  • The global capsaicin market was valued at USD 8.89 million in 2024 and is projected to reach USD 17.83 million by 2037, growing at a CAGR of 5.5% during the forecast period[2].
  • Another estimate suggests the market was valued at USD 384.3 million in 2023 and is expected to reach USD 483.5 million by 2030, with a CAGR of 5.8% from 2024-2030[5].

Key Drivers

  • Increasing Demand in Food and Beverage: Capsaicin is widely used as a natural flavoring and coloring agent in the food industry, driven by consumer preference for spicy and tasty food products[2][5].
  • Pharmaceutical Applications: The medicine segment is anticipated to account for the largest market share due to capsaicin's analgesic, pain-relieving, and anti-inflammatory properties. It is used in producing pain-relieving patches, balms, and other medications[2].
  • Cosmetic and Other Uses: Capsaicin is also valued in the cosmetic industry for its anti-inflammatory and pain-relieving properties, and it is used in treating skin conditions such as psoriasis and itching[2].

Market Segmentation

  • By Application: The market is segmented into food, medicine, cosmetics, pesticides, and others. The medicine segment is expected to dominate the market due to the wide application of capsaicin in pain-relieving medicines[2].
  • By Product Type: The 95% purity segment is anticipated to hold the largest market share due to its extensive use in the pharmaceutical industry and research activities[2].

Regional Market

  • North America and Latin America: These regions are expected to see significant growth due to the large-scale cultivation of chili peppers and the rising demand for pain-relieving products. The Latin American market is particularly driven by favorable climatic conditions and the presence of spicy chili varieties[2].

Health Benefits and Applications of Capsaicin

Capsaicin's health benefits are multifaceted, contributing to its growing demand.

Pain Relief

  • Capsaicin has been proven effective in relieving pain from conditions such as postherpetic neuralgia, diabetic neuropathy, and osteoarthritis. A double-blind, placebo-controlled study showed that capsaicin cream significantly reduced pain intensity in patients with chronic neuropathic pain[2].

Weight Loss and Metabolic Benefits

  • Capsaicin has been found to increase metabolic rate and reduce appetite, aiding in weight loss. A study published in the American Journal of Clinical Nutrition indicated that capsaicin consumption increased energy expenditure and fat oxidation[2].

Anti-Cancer Properties

  • Research suggests that capsaicin may have anticancer properties, inducing apoptosis (cell death) in cancer cells and inhibiting tumor growth[2].

Skin Conditions

  • Topical capsaicin is effective in reducing itching in patients with various skin conditions, including atopic dermatitis, psoriasis, and urticaria[2].

Challenges and Future Outlook

While the capsaicin market is growing, there are several challenges and considerations.

Regulatory Approvals

  • The success of clinical trials, such as the AV001 trial for QUTENZA, is crucial for expanding the indications of capsaicin-based treatments. Regulatory approvals will play a significant role in the market's future growth[1][4].

Consumer Awareness

  • Growing awareness of capsaicin's health benefits is driving market growth. However, educating consumers about the safe and effective use of capsaicin products remains essential[2][5].

Competition and Innovation

  • The market is competitive, with various players involved in the production and distribution of capsaicin. Continuous innovation in product formulation and application will be key to maintaining market share[2][5].

Key Takeaways

  • Clinical Trials: The ongoing Phase III trial for QUTENZA (capsaicin 8% topical system) aims to treat post-surgical neuropathic pain, a significant unmet medical need.
  • Market Growth: The global capsaicin market is projected to grow significantly, driven by demand in the food, pharmaceutical, and cosmetic industries.
  • Health Benefits: Capsaicin offers various health benefits, including pain relief, weight loss, and potential anti-cancer properties.
  • Regulatory and Consumer Factors: Regulatory approvals and consumer awareness are critical for the market's future growth.

FAQs

What is the current status of the QUTENZA clinical trial?

The recruitment for the Phase III AV001 clinical trial of QUTENZA (capsaicin 8% topical system) has been completed, and the trial is ongoing to assess its efficacy, safety, and tolerability in treating post-surgical neuropathic pain[1][4].

What are the primary applications of capsaicin?

Capsaicin is primarily used in the food industry as a flavoring and coloring agent, in the pharmaceutical industry for its analgesic and anti-inflammatory properties, and in the cosmetic industry for treating skin conditions[2].

How is the capsaicin market expected to grow?

The global capsaicin market is projected to grow at a CAGR of 5.5% to 5.8% from 2024 to 2030/2037, reaching a market size of USD 17.83 million to USD 483.5 million by the end of the forecast period[2][5].

What are the health benefits of capsaicin?

Capsaicin offers several health benefits, including pain relief, weight loss, increased metabolism, and potential anti-cancer properties. It is also effective in treating skin conditions such as psoriasis and itching[2].

What are the challenges facing the capsaicin market?

The market faces challenges such as regulatory approvals, consumer awareness, and competition. Continuous innovation and education about the safe and effective use of capsaicin products are essential for market growth[2][5].

How does capsaicin help in weight loss?

Capsaicin aids in weight loss by increasing metabolic rate and reducing appetite. Studies have shown that capsaicin consumption increases energy expenditure and fat oxidation[2].

Sources

  1. Grunenthal Press Release: "Completion of Recruitment for Phase III QUTENZA Trial AV001" - November 7, 2024.
  2. Research Nester Report: "Capsaicin Market Size & Share, Growth Analysis - 2037" - December 20, 2024.
  3. Straits Research Report: "Global Clinical Trials Market Size, Top Share, Trends, Forecast by 2033" - October 22, 2024.
  4. Clinical Trials Arena News: "Averitas completes recruitment for trial of QUTENZA to treat PSNP" - November 8, 2024.
  5. Verified Market Research Report: "Capsaicin Market Size And Forecast" - 2024.
Last updated: 2025-01-07

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