Drugs / Capsaicin
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Capsaicin

Small molecule targets TRPV1 via activation

Developed for
neuropathy, painful · herpes zoster · neuralgia · HIV infectious disease · postherpetic neuralgia · osteoarthritis, knee · rhinitis · diabetic neuropathy
+36 more · diabetic polyneuropathy · chemotherapy-induced neuropathy · obesity disorder · diabetes mellitus · ischemic stroke · Morton neuroma · peripheral nerve lesion · peripheral neuropathy · polyneuropathy · burning mouth syndrome · cannabinoid hyperemesis syndrome · cerebrovascular disorder · chemotherapy-induced toxicity · coccygodynia · cyclic vomiting syndrome · disorder of pharynx · epicondylitis · female breast carcinoma · hyperemesis gravidarum · hyperlipidemia · interstitial cystitis · myofascial pain syndrome · neuroma · osteoarthritis · osteoarthritis, hand · peripheral nervous system disorder · psoriasis · sickle cell disease · spinal cord injury · syncope, familial vasovagal · temporomandibular joint disorder · traumatic neuropathy · vulvar disease · vulvodynia · chronic pain syndrome · cough variant asthma
Investigated by
NeurogesX · Aalborg University · AlgoRx Pharmaceuticals · Astellas Pharma Inc · Centrexion Therapeutics · University of Florida
+92 more · Centenario Hospital Miguel Hidalgo · Grünenthal GmbH · The University of Texas Health Science Center, Houston · Universitaire Ziekenhuizen KU Leuven · American Academy of Otolaryngic Allergy · Anesiva, Inc. · Averitas Pharma, Inc. · Bassett Healthcare · Boehringer Ingelheim · Institut Cancerologie de l'Ouest · Mexican Social Security Institute · National Institute of Dental and Craniofacial Research (NIDCR) · University of Copenhagen · University of Montana · Academic Medical Center - University of Amsterdam · American Heart Association · Arafarma Group, S.A. · Arthritis Research UK Pain Centre · Astellas Pharma Europe Ltd. · Bangkok Drug company · Bangkok Laboratories and Cosmetics · Cantonal Hospital of Aarau, Switzerland · Carilion Clinic · Central Hospital, Nancy, France · Centre Hospitalier Universitaire de Besancon · Children's Hospital of Michigan · Chorda Pharma, Inc. · Christian Medical College, Vellore, India · Columbia University · Consorci Sanitari del Maresme · Corporacion Parc Tauli · Emma Aitken · Federal University of Minas Gerais · Fundación Teófilo Hernando, Spain · Georg Kägi, MD · Henry Ford Health System · Hjalte Holm Andersen · Hospital de Mataró · Imperial College London · Institut Claudius Regaud · Institut de Cancérologie de la Loire · Instituto de Salud Carlos III · Istanbul University · Jiangsu Aosaikang Pharmaceutical Co., Ltd. · Juan Manuel Marquez Romero · Khon Kaen University · LN. Jessica Lucia Barajas Vega · Leiden University Medical Center · M.D. Anderson Cancer Center · Mahidol University · Mayo Clinic · Merck Sharp & Dohme LLC · Metabolife · Monash University · Nadine ATTAL · Nantes University Hospital · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Nottingham University Hospitals NHS Trust · Patient-Centered Outcomes Research Institute · Penn State University · PhD. Teresa Arcelia Garcia Cobian · Propella Therapeutics · Queen's University, Belfast · Reinier de Graaf Groep · Samyang Biopharmaceuticals Corporation · Stuart Mazzone · Thailand Research Fund · Thammasat University · The Scientific and Technological Research Council of Turkey · The University of Texas Health Science Center at San Antonio · United States Department of Defense · United Therapeutics · University Hospital of Saint-Etienne · University Hospital, Antwerp · all 98 on the full record

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) QUTENZA — 2020-07-17 fda.gov ↗
Approved US (FDA) QUTENZA — 2009-11-16 fda.gov ↗
Approved EU (EMA) Qutenza — 2009-05-15 europa.eu ↗

Trials 111 · started per year

today
EU approved 2009
US approved 2009
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 05 trials · 1 missed
Phase 0 NCT06744816 Dec 2025 → Nov 2027 expected chemotherapy-induced neuropathy M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 0 NCT06444594 Jul 2024 → Dec 2025 overdue premature aging syndrome Penn State University Recruiting No outcome recorded
Phase 0 NCT05649228 Dec 2022 → Jan 2024 — Carilion Clinic Completed No outcome recorded
Phase 0 NCT04256733 May 2019 → Nov 2020 — University of Montana Completed Missed primary
Phase 0 NCT02240329 Mar 2013 → Jun 2015 traumatic brain injury University of Florida Completed No outcome recorded
Phase 110 trials · 2 missed
Phase 1 NCT06614608 Oct 2024 → Apr 2025 overdue osteoarthritis, knee Jiangsu Aosaikang Pharmaceutical Co., Ltd. Not yet recruiting No outcome recorded
Phase 1 NCT06809569 Sep → Dec 2023 — Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1 NCT05226299 May 2021 → May 2022 — University of Montana Completed Missed primary
Phase 1 NCT04545892 Dec 2019 → Jul 2020 stroke disorder Juan Manuel Marquez Romero Completed No outcome recorded
Phase 1 NCT03899246 Jul 2019 → Mar 2020 neuropathy, painful, sickle cell disease Children's Hospital of Michigan Completed No outcome recorded
Phase 1 NCT03511846 Mar 2018 → May 2028 expected SUNCT syndrome, cluster headache syndrome, hemicrania continua, migraine disorder +1 The University of Texas Health Science Center, Houston Enrolling by invitation No outcome recorded
Phase 1 NCT03074162 Apr → Jun 2017 — Boehringer Ingelheim Completed Missed primary
Phase 1 NCT01883102 Jun 2013 — Mayo Clinic Completed No outcome recorded
Phase 1 NCT00254449 Nov 2005 → May 2006 — NeurogesX Completed No outcome recorded
Phase 1 NCT00528216 — — NeurogesX Completed No outcome recorded
Phase 1/26 trials · 1 met primary
Phase 1/2 NCT03122145 May 2017 → Feb 2019 — University of Florida Completed No outcome recorded
Phase 1/2 NCT02769910 May → Jul 2016 — Hjalte Holm Andersen Completed No outcome recorded
Phase 1/2 NCT02183519 Oct 2014 → Aug 2015 Parkinson disease University of Florida Completed No outcome recorded
Phase 1/2 NCT01907321 Jan 2011 → Apr 2015 ischemic stroke University of Florida Completed Met primary
Phase 1/2 NCT02228928 Feb 2009 → May 2011 peripheral nerve lesion, postherpetic neuralgia Samyang Biopharmaceuticals Corporation Completed No outcome recorded
Phase 1/2 NCT00004316 Jun 1995 → Aug 2007 interstitial cystitis, vulvar disease National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Completed No outcome recorded
Phase 231 trials · 1 met primary · 2 missed
Phase 2 NCT07406971 Sep 2025 → Sep 2026 overdue ischemic stroke Mexican Social Security Institute Recruiting No outcome recorded
Phase 2 NCT05543837 Sep 2022 cerebrovascular disorder Mexican Social Security Institute Completed No outcome recorded
Phase 2 NCT05098067 May → Oct 2022 hyperemesis gravidarum Women and Infants Hospital of Rhode Island Completed Missed primary
Phase 2 NCT04470752 Aug 2021 → Dec 2024 — Georg Kägi, MD Unknown No outcome recorded
Phase 2 NCT04972123 Jul 2021 → Aug 2023 syncope, familial vasovagal University of Wisconsin, Madison Completed Missed primary
Phase 2 NCT04704453 Apr 2021 → Apr 2025 head and neck cancer Institut Claudius Regaud Completed No outcome recorded
Phase 2 NCT04918069 Oct 2019 → May 2022 chemotherapy-induced toxicity Christian Medical College, Vellore, India Completed No outcome recorded
Phase 2 NCT03528369 May → Oct 2018 osteoarthritis, knee Propella Therapeutics Completed No outcome recorded
Phase 2 NCT03223350 Dec 2017 → Aug 2019 cyclic vomiting syndrome Henry Ford Health System Completed No outcome recorded
Phase 2 NCT03317613 Nov 2017 → Dec 2020 neuropathy, painful University Hospital of Saint-Etienne Completed No outcome recorded
Phase 2/37 trials
Phase 2/3 NCT02823912 Oct 2016 → Apr 2017 hyperlipidemia, obesity disorder University of Guadalajara Unknown No outcome recorded
Phase 2/3 NCT02854670 Jan 2016 → Feb 2021 vulvodynia Centre Hospitalier Universitaire de Besancon Terminated No outcome recorded Stop: Enrollment
Phase 2/3 NCT00993070 Oct 2009 → Dec 2011 diabetic polyneuropathy Thammasat University Completed No outcome recorded
Phase 2/3 NCT01125215 Sep 2009 → Oct 2013 neuropathy, painful Mahidol University Unknown No outcome recorded
Phase 2/3 NCT00302263 Jan → Apr 2005 obesity disorder University of Copenhagen Completed No outcome recorded
Phase 2/3 NCT00302276 Jan → Jul 2004 obesity disorder University of Copenhagen Completed No outcome recorded
Phase 2/3 NCT00061776 — herpes zoster, neuralgia NeurogesX Completed No outcome recorded
Phase 318 trials · 5 met primary · 3 missed
Phase 3 NCT06023706 Nov 2023 → May 2027 expected coccygodynia, neuropathy, painful Nantes University Hospital Recruiting No outcome recorded
Phase 3 NCT05840562 Oct 2023 → Mar 2028 expected chemotherapy-induced neuropathy Institut Cancerologie de l'Ouest Recruiting No outcome recorded
Phase 3 NCT04967664 Jul 2021 → Aug 2025 neuropathy, painful Averitas Pharma, Inc. Completed No outcome recorded
Phase 3 NCT05093478 Sep 2019 → Nov 2023 rhinitis The University of Texas Health Science Center, Houston Completed No outcome recorded
Phase 3 NCT03794388 Mar 2019 → Nov 2022 female breast carcinoma Institut Cancerologie de l'Ouest Completed No outcome recorded
Phase 3 NCT02700815 May 2016 → Jul 2017 — Boehringer Ingelheim Completed Met primary
Phase 3 NCT03153813 Jul 2015 → Dec 2017 — Nadine ATTAL Terminated No outcome recorded
Phase 3 NCT01533428 Feb 2012 → Feb 2014 diabetic polyneuropathy Astellas Pharma Inc Completed Met primary
Phase 3 NCT01478607 Nov 2011 → Feb 2014 diabetic polyneuropathy Astellas Pharma Inc Completed No outcome recorded
Phase 3 NCT05029297 Nov 2010 → Oct 2018 diabetic neuropathy Arafarma Group, S.A. Completed No outcome recorded
Phase 417 trials · 1 met primary
Phase 4 NCT07795593 Oct 2026 → May 2031 expected diabetic kidney disease, diabetic neuropathy University of Michigan Not yet recruiting No outcome recorded
Phase 4 NCT06444919 Mar 2025 → Jan 2028 expected neuropathy, painful, osteoarthritis, hand University Hospital, Clermont-Ferrand Recruiting No outcome recorded
Phase 4 NCT06040190 Nov 2023 → Jul 2026 overdue burning mouth syndrome Federal University of Minas Gerais Active not recruiting No outcome recorded
Phase 4 NCT05298202 May → Oct 2022 — University of Nebraska Completed Mixed
Phase 4 NCT04283292 Dec 2020 → Mar 2022 cannabinoid hyperemesis syndrome University of Virginia Completed No outcome recorded
Phase 4 NCT04238208 Jan → Dec 2019 diabetic polyneuropathy Corporacion Parc Tauli Completed No outcome recorded
Phase 4 NCT03348735 Dec 2018 → Apr 2021 neuropathy, painful University Hospital, Antwerp Terminated No outcome recorded
Phase 4 NCT02288156 Jul 2015 → Dec 2018 rhinitis Universitaire Ziekenhuizen KU Leuven Completed No outcome recorded
Phase 4 NCT01704339 Dec 2012 → Dec 2013 end stage renal failure, neuropathy, painful Emma Aitken Unknown No outcome recorded
Phase 4 NCT01713426 Jul 2012 → Sep 2013 neuropathy, painful, postherpetic neuralgia, traumatic neuropathy Astellas Pharma Europe Ltd. Completed Met primary
Phase not applicable17 trials
— NCT07688525 Aug → Nov 2026 expected — University of Sherbrooke Not yet recruiting No outcome recorded
— NCT07598994 Aug 2025 → Apr 2026 temporomandibular joint disorder Istanbul University Completed No outcome recorded
— NCT07625475 May 2024 → Apr 2025 autoimmune disorder of central nervous system University of Guelph Completed No outcome recorded
— NCT06197529 Nov 2023 → Mar 2024 — Aalborg University Completed No outcome recorded
— NCT05560516 Dec 2022 → Dec 2024 chemotherapy-induced neuropathy Academic Medical Center - University of Amsterdam Unknown No outcome recorded
— NCT05735626 Jul 2021 → Dec 2023 disorder of pharynx, stroke disorder Hospital de Mataró Unknown No outcome recorded
— NCT04700007 Jan → Dec 2021 — Aalborg University Completed No outcome recorded
— NCT04485689 Jul → Dec 2020 — Aalborg University Unknown No outcome recorded
— NCT03722849 Mar 2019 → May 2022 — Stuart Mazzone Completed No outcome recorded
— NCT03587220 Aug 2018 → Aug 2019 neuropathy, painful, sunburn Aalborg University Completed No outcome recorded
Comparator or background therapy25 trials
Phase 0 NCT06971250 Background May 2025 — Stefan Heber Completed No outcome recorded
Phase 0 NCT03944889 Comparator Jul 2019 → Jul 2020 — Toronto Rehabilitation Institute Completed No outcome recorded
Phase 0 NCT02766517 Background Sep 2016 → Jan 2017 migraine disorder Eli Lilly and Company Completed No outcome recorded
Phase 1 NCT03576508 Comparator Jun → Sep 2018 osteoarthritis, knee Centrexion Therapeutics Completed No outcome recorded
Phase 1 NCT03472677 Background Mar → Jul 2018 osteoarthritis, knee Centrexion Therapeutics Completed No outcome recorded

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2024-03-15 Chorda Pharma, Inc. Results Top-Line Results from Clinical Trial Show Capsadyn™ Does Not Burn chordapharma.com ↗

Evidence & citations 21 cited values

Every value below carries the sentence it was read from. 141 sources stand behind the page.

FieldValueCited text
Known as capsaicin “A Multicenter Randomized, Double-Blind, Controlled Study to Evaluate Safety, Tolerability and Preliminary Efficacy of Two Capsaicin Concentration Variations of NGX-1998 (10% or...” NCT01228838 ↗
118

“The present study will explore the efficacy of single applications of Qutenza® (capsaicin 8% patch) in reducing site pain caused by continuous SC infusion of Remodulin®, in...” NCT01393795 ↗

“It has previously been shown that a combination of tyrosine, capsaicin, catechines, and caffeine may stimulate the sympathetic nervous system and promote satiety, lipolysis and...” NCT00302276 ↗

“Qutenza (topical capsaicin 8%) is a new treatment made from chilli peppers which is applied to the skin as a patch and works directly at the nerve endings in the skin to prevent pain.” NCT01704339 ↗

“To confirm the efficacy, tolerability, and safety of NGX-4010, an 8% capsaicin dermal patch (capsaicin 640 µg/cm(2) ), in patients with postherpetic neuralgia (PHN).” PMID 21087403 ↗ Nov 2010

“5% ASKC200 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 5% for this study.” NCT06614608 ↗

“CGS-200-1 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 1% for this study.” NCT03528369 ↗

“Bioactive Metobes compound (green tea extract, tyrosine, caffeine and capsaicin) without calcium together with 5 mg propranolol.” NCT00302263 ↗

“QUTENZA® is a skin patch with a high concentration of capsaicin (8%) which is the component responsible for spicy peppers.” NCT02822625 ↗

“Patients received placebo vehicle or capsaicin 15 mg (Anesiva 4975) by instillation immediately prior to wound closure.” PMID 21971213 ↗ Dec 2011

“Treatment by application of capsaicin 8% (Qutenza®) patches 3 months apart (Month 1, Month 4 and Month 7).” NCT04704453 ↗

Show 108 more sources

Known as 4975 “The study drug, 4975, will be administered in various dosing regimens by intra-articular injection followed by an observation period of up to 12 weeks.” NCT00667654 ↗
1

“4975, highly purified capsaicin” NCT00683267 ↗

Known as 8-methyl-N-vanillyl-6-nonenamide “The soft gel capsules used in the study are easily digested in the stomach and contain standardised doses of 0,4 mg Capsicum oleoresin with the main component capsaicin...” NCT04125563 ↗
Known as 8methylNvannilyl6nonenamide “Capsaicin 8methylNvannilyl6nonenamide) activates TRPV1, a nonselective cation channel activated directly by heat, and low pH, and indirectly by a number of inflammatory...” NCT00771511 ↗
Known as ALGRX 4975 ClinicalTrials.gov intervention name — accepted as the source's own label NCT00130962 ↗
4

NCT00146198 ↗

NCT00130949 ↗

NCT00132392 ↗

NCT00133133 ↗

Known as Anesiva 4975 “Patients received placebo vehicle or capsaicin 15 mg (Anesiva 4975) by instillation immediately prior to wound closure.” PMID 21971213 ↗ Dec 2011
Known as ARAFARMADOL “CAPSAICIN cream (ARAFARMADOL® ) for 8 weeks.” NCT05029297 ↗
Known as Cap “Cap is 0.10% capsaicin alone and is an active comparator.” NCT05649228 ↗
Known as Capsaicin patch “Capsaicin patch” NCT04238208 ↗
Known as CAPSIKA gel “0.0125% Capsaicin gel "CAPSIKA gel"” NCT00471055 ↗
Known as CNTX-4975 ClinicalTrials.gov intervention name — accepted as the source's own label NCT02558439 ↗
3

NCT02678793 ↗

NCT00667654 ↗

NCT02283957 ↗

Known as NGX-1998 “A Multicenter Randomized, Double-Blind, Controlled Study to Evaluate Safety, Tolerability and Preliminary Efficacy of Two Capsaicin Concentration Variations of NGX-1998 (10% or...” NCT01228838 ↗
1

“Capsaicin Topical Liquid, NGX-1998 (10% w/w)” NCT00912262 ↗

Known as NGX-4010 “The objective of the current open-label study was to assess the safety of repeated applications of NGX-4010, a high-concentration capsaicin patch (capsaicin 8%), over one year,...” PMID 20538187 ↗ Jun 2010
9

“The purpose of the study is determine if an investigational drug, NGX-4010 (high-concentration capsaicin dermal patches) is effective in treating pain associated with...” NCT00061776 ↗

“The purpose of the study is to determine if an investigational drug, NGX-4010 (high-concentration capsaicin patch), is safe, tolerable and effective in treating painful...” NCT00085761 ↗

“To confirm the efficacy, tolerability, and safety of NGX-4010, an 8% capsaicin dermal patch (capsaicin 640 µg/cm(2) ), in patients with postherpetic neuralgia (PHN).” PMID 21087403 ↗ Nov 2010

“Efficacy, safety, and tolerability of NGX-4010, capsaicin 8% patch, in an open-label study of patients with peripheral neuropathic pain.” PMID 21612836 ↗ May 2011

“NGX-4010 is a capsaicin 8% dermal patch with demonstrated efficacy in the treatment of HIV-DSP.” PMID 23351618 ↗ Jan 2013

“NGX-4010, a capsaicin 8% dermal patch” PMID 22182397 ↗ Dec 2011

NCT00321672 ↗

NCT00254449 ↗

NCT00115310 ↗

Known as QUTENZA “The present study will explore the efficacy of single applications of Qutenza® (capsaicin 8% patch) in reducing site pain caused by continuous SC infusion of Remodulin®, in...” NCT01393795 ↗
15

“8% Capsaicin patch [8% w/w] 640 µg/cm² of adhesive, patch area 280 cm2 (20 cm x 14 cm), (Qutenza®; capsaicin 179 mg patch, Astella Pharma Europe Ltd. Chertsey, UK)” NCT04238208 ↗

“Capsaicin patches (dosage form: patch 8% Qutenza) will be applied on 4x4 cm squared areas on the volar forearm.” NCT03587220 ↗

“Treatment by application of capsaicin 8% (Qutenza®) patches 3 months apart (Month 1, Month 4 and Month 7).” NCT04704453 ↗

“Single treatment with QUTENZA (topical capsaicin 8%)” NCT01704339 ↗

“Qutenza (capsaicin) 8% topical system” NCT04967664 ↗

“capsaicin 8% patches (Qutenza)” NCT03153813 ↗

“a capsaicin patch 8 %(Qutenza)” NCT01699854 ↗

NCT03317613 ↗

NCT01416116 ↗

NCT03576508 ↗

Show 5 more sources

Known as Qutenza Patch “Treatment with Qutenza Patch (Topical Capsaicin)” NCT06744816 ↗
Known as trans-capsaicin “OBJECTIVE: To assess the efficacy and safety of high-purity synthetic trans-capsaicin (CNTX-4975) in patients with chronic moderate-to-severe osteoarthritis (OA)-associated knee pain.” PMID 30888737 ↗ Jul 2019
Known as Zostrix “5 mL of 0.075% capsaicin cream (Zostrix; Hi-Tech Pharmacal, Amityville, NY, USA) applied to a 5 x 10 cm target region on the lateral elbow and to bilateral C5-C6...” NCT07625475 ↗
1

“Participants received either a dose of 2.5 ml (75µg/ml) capsaicin cream (treatment, Zostrix brand) or skin lotion (placebo).” NCT04361149 ↗

Action Activate “Binding of capsaicin to the vanilloid-1 receptor produces initial activation” NCT00008476 ↗
Modality Small molecule “natural alkaloid derived from hot chili peppers” NCT00697034 ↗
Route Other “Therapy for all groups is administered intravesically every week for 5 weeks.” NCT00004316 ↗
Target TRPV1 “activates TRPV1” NCT00771511 ↗