Clinical Trials

Capsaicin has been evaluated in numerous clinical trials spanning Phase 1 through Phase 4 as well as unassigned phases, focusing on conditions such as peripheral neuropathic pain, painful diabetic neuropathy, coccygodynia, chronic cough, pre-hypertension, and dermal blood flow in healthy volunteers. Conducted globally with varied recruitment statuses—including recruiting, completed, and not yet recruiting—these protocols are sponsored by academic centers, hospital networks, and pharmaceutical entities such as Eli Lilly, Mallinckrodt, Nantes University Hospital, and Skidmore College. Advanced-phase trials focus primarily on evaluating the analgesic efficacy of topical capsaicin formulations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03952845 NOT_YET_RECRUITING
Tolerance; Capsaicin; Rhinitis
Nova Scotia Health Authority
2025-08-01
NCT07443553 NOT_YET_RECRUITING
Postamputation Pain
Northwestern University
2026-10-31
NCT05997979 RECRUITING
Neuropathic Pain; Chronic Pain
University Hospital, Brest
2024-03-05 PHASE3
NCT03511846 ENROLLING_BY_INVITATION
Migraine; Cluster Headache; Trigeminal Autonomic Cephalgia; Hemicrania Continua; Paroxysmal Hemicrania; SUNCT; Short-Lasting Unilateral Neuralgiform Headache With Conjunctival Injection and Tearing
The University of Texas Health Science Center, Houston
2018-03-21 PHASE1
NCT07660510 NOT_YET_RECRUITING
Neuropathic Pain; Nociplastic Pain
Nantes University Hospital
2026-09-01
NCT05840562 RECRUITING
Chemotherapy-induced Peripheral Neuropathy
Institut Cancerologie de l'Ouest
2023-10-20 PHASE3
NCT06444919 RECRUITING
Osteoarthritis Hand; Neuropathic Pain
University Hospital, Clermont-Ferrand
2025-03-07 PHASE4
NCT06744816 RECRUITING
Peripheral Neuropathy Due to Chemotherapy
M.D. Anderson Cancer Center
2025-12-11 EARLY_PHASE1
NCT07260656 RECRUITING
Diabetic Neuropathies, Painful; Diabetic Foot; Diabetic Peripheral Neuropathy
Carilion Clinic
2025-11-26 EARLY_PHASE1
NCT06807164 RECRUITING
Post-Mastectomy Neuropathic Pain Syndrome
Centre Oscar Lambret
2026-03-31 PHASE2
NCT07719868 NOT_YET_RECRUITING
Pain Management; Capsaicin-Induced Pain; Transcranial Magnetic Stimulation Repetitive; Electroencephalography; Vagus Nerve Stimulation; Neuromodulation; Analgesia
Second Affiliated Hospital, Zhejiang University, School of Medicine
2026-07-10
NCT07602387 RECRUITING
Patients With Taxane-induced Chronic Neuropathic Pain
Hospital Ambroise Paré Paris
2024-03-12
NCT06023706 RECRUITING
Coccyx Disorder; Neuropathic Pain; Coccygodynia
Nantes University Hospital
2023-11-08 PHASE3
NCT07755930 NOT_YET_RECRUITING
Marsili Syndrome
Aalborg University
2026-08-01
NCT07122973 RECRUITING
Pain; Itch
Aalborg University
2025-09-17
NCT04415892 RECRUITING
Chemotherapy-induced Peripheral Neuropathy
Universitaire Ziekenhuizen KU Leuven
2019-10-01
NCT07688525 NOT_YET_RECRUITING
Kinesiophobia (Fear of Movement); Experimental Pain
Université de Sherbrooke
2026-08-01
NCT07406971 RECRUITING
Ischemic Stroke
Instituto Mexicano del Seguro Social
2025-09-01 PHASE2
NCT07602361 ACTIVE_NOT_RECRUITING
Overweight and Obesity
Universidad Autonoma de Baja California
2026-04-22
NCT07717918 RECRUITING
Healthy
Bausch & Lomb Incorporated
2026-07-06 PHASE1
NCT06040190 COMPLETED
Burning Mouth Syndrome
Federal University of Minas Gerais
2023-11-01 PHASE4
NCT07630571 COMPLETED
Oral Pain; Oral Pungent Sensation; Capsaicin-Induced Pain; AITC-Induced Irritation; Oral Mucosa Discomfort
Nakhia Impex LLC
2026-06-05
NCT07054840 RECRUITING
Aging; Older Adults; Pain; Motor Learning
University of Delaware
2025-08-26
NCT07598994 COMPLETED
Temporomandibular Disorders (TMD); Temporomandibular Pain
Istanbul University
2025-08-28
NCT05958173 UNKNOWN
Oropharyngeal Dysphagia; Swallowing Disorder
Hospital de Mataró
2023-09-01
NCT06363305 UNKNOWN
Pre Hypertension; Hypertension
Skidmore College
2024-07-08
NCT06944665 NOT_YET_RECRUITING
Acute Low Back Pain
Xiaonan Huang
2025-05-05
NCT04967664 COMPLETED
Post Surgical Neuropathic Pain
Averitas Pharma, Inc.
2021-07-13 PHASE3
NCT07060976 COMPLETED
Healthy Participants
Novamed Laboratories Pvt. Ltd.
2025-07-21
NCT06612658 NOT_YET_RECRUITING
None Volunteer
Hofstra University
2024-10-01
NCT06971250 COMPLETED
Pain
Stefan Heber
2025-05-08 EARLY_PHASE1
NCT07625475 COMPLETED
Hyperalgesia; Pain Perception; Central Nervous System Sensitization; Pain Threshold
University of Guelph
2024-05-01
NCT04398719 COMPLETED
CBD; Healthy
Yale University
2021-05-07 EARLY_PHASE1
NCT05726929 COMPLETED
Breast Cancer; Neuropathic Pain
Institut Toulousain d'Ostéopathie
2023-01-11
NCT05720871 UNKNOWN
Oropharyngeal Dysphagia; Stroke; Stroke, Complication; Swallowing Disorder
Hospital de Mataró
2022-11-28
NCT04470752 UNKNOWN
Dysphagia, Late Effect of Stroke
Georg Kägi, MD
2021-08-24 PHASE2
NCT06363305 Not yet recruiting
Pre Hypertension|Hypertension
Skidmore College|American Heart Association
2024-05-01 Not Applicable
NCT05713019 UNKNOWN
Cough
Imperial College London
2023-02-28
NCT06197529 COMPLETED
Healthy
Aalborg University
2023-11-21
NCT05649228 COMPLETED
Pain Management
Carilion Clinic
2022-12-13 EARLY_PHASE1
NCT05813223 Recruiting
Chronic Cough
Stuart Mazzone|Merck Sharp & Dohme LLC|Melbourne Health|Monash University|University of Melbourne
2024-01-01 Early Phase 1
NCT05059418 UNKNOWN
Burning Mouth Syndrome
Malmö University
2021-11-01
NCT06809569 COMPLETED
Healthy
Merck Sharp & Dohme LLC
2023-09-25 PHASE1
NCT05817591 Recruiting
Peripheral Neuropathic Pain
Centre Hospitalier Annecy Genevois
2023-12-14 --
NCT05735626 UNKNOWN
Stroke; Stroke, Acute; Oropharyngeal Dysphagia; Swallowing Disorder
Hospital de Mataró
2021-07-01
NCT05093478 COMPLETED
Non-allergic Rhinitis
The University of Texas Health Science Center, Houston
2019-09-10 PHASE3
NCT05625776 COMPLETED
Pain, Acute; Cognition
University of Delaware
2023-03-22
NCT04972123 COMPLETED
Syncope, Vasovagal
University of Wisconsin, Madison
2021-07-20 PHASE2
NCT05835258 COMPLETED
Bioavailability
Fundació Eurecat
2023-05-30
NCT05654298 COMPLETED
Migraine
Universitaire Ziekenhuizen KU Leuven
2022-03-15
NCT03794388 COMPLETED
Breast Cancer Patient
Institut Cancerologie de l'Ouest
2019-03-19 PHASE3
NCT05098067 COMPLETED
Hyperemesis Gravidarum; Nausea Gravidarum; Vomiting of Pregnancy
Women and Infants Hospital of Rhode Island
2022-05-24 PHASE2
NCT05298202 COMPLETED
Acute Exercise; Heat Exposure
University of Nebraska
2022-05-25 PHASE4
NCT05543837 COMPLETED
Cerebral Circulatory Disorder
Instituto Mexicano del Seguro Social
2022-09-20 PHASE2
NCT04125563 COMPLETED
Cough
Vastra Gotaland Region
2019-06-01 PHASE2
NCT05181852 UNKNOWN
Pain
Initiator Pharma
2022-01-05 PHASE1
NCT05226299 COMPLETED
Cough
University of Montana
2021-05-01 PHASE1
NCT04918069 COMPLETED
Chemotherapy-induced Nausea and Vomiting
Christian Medical College, Vellore, India
2019-10-18 PHASE2
NCT03722849 COMPLETED
Cough
Stuart Mazzone
2019-03-01
NCT04741620 COMPLETED
Oropharyngeal Dysphagia; Dysphagia; Swallowing Disorder
Hospital de Mataró
2019-01-17
NCT04283292 COMPLETED
Cannabinoid Hyperemesis Syndrome
University of Virginia
2020-12-01 PHASE4
NCT04700007 COMPLETED
Itch
Aalborg University
2021-01-18
NCT05158309 COMPLETED
Prolonged Pain, EEG, Resting State Functional Connectivity
Aalborg University
2021-05-31
NCT02441660 COMPLETED
Spinal Cord Injuries; Neuropathic Pain
The University of Texas Health Science Center at San Antonio
2016-04
NCT03348735 TERMINATED
Neuropathic Pain
University Hospital, Antwerp
2018-12-03 PHASE4
NCT02854670 TERMINATED
Vestibulodynia
Centre Hospitalier Universitaire de Besancon
2016-01-20 PHASE2; PHASE3
NCT03603522 COMPLETED
Atopic Asthma
McMaster University
2019-07-16
NCT02869867 COMPLETED
Localized Neuropathic Pain
Centre Hospitalier Departemental Vendee
2017-03-02
NCT03317613 COMPLETED
Neuropathic Pain
Centre Hospitalier Universitaire de Saint Etienne
2017-11-09 PHASE2
NCT04485689 UNKNOWN
Healthy
Aalborg University
2020-07-01
NCT04256733 COMPLETED
Cough
University of Montana
2019-05-01 EARLY_PHASE1
NCT04545892 COMPLETED
Stroke
Juan Manuel Marquez Romero
2019-12-01 PHASE1
NCT03944889 COMPLETED
Central Sensitisation
Toronto Rehabilitation Institute
2019-07-01 EARLY_PHASE1
NCT03330639 WITHDRAWN
Headache Disorders
University of Nebraska
2020-06-23
NCT03899246 COMPLETED
Neuropathic Pain; Sickle Cell Disease
Children's Hospital of Michigan
2019-07-03 PHASE1
NCT04399525 COMPLETED
Pruritus
Universitaire Ziekenhuizen KU Leuven
2019-10-28
NCT04361149 COMPLETED
Central Sensitisation; Motor Disorders
Toronto Rehabilitation Institute
2019-10-01 PHASE4
NCT04238208 COMPLETED
Diabetic Nerve Problems; Diabetic Neuropathy; Diabetic Complications Neurological
Corporacion Parc Tauli
2019-01-10 PHASE4
NCT03883880 TERMINATED
Diet, Food Choice, Taste
Purdue University
2019-01-05
NCT04399148 COMPLETED
Pruritus
Universitaire Ziekenhuizen KU Leuven
2019-06-11
NCT03587220 COMPLETED
Capsaicin; Ultaviolet B Light Burn; Neuropathic Pain; Lidocaine
Aalborg University
2018-08-01
NCT03223350 COMPLETED
Cyclical Vomiting
Henry Ford Health System
2017-12-20 PHASE2
NCT02493257 COMPLETED
Nonallergic Irritant Rhinitis
The University of Texas Health Science Center, Houston
2014-10 PHASE2
NCT03859583 UNKNOWN
Obesity; Insulin Resistance
George Mason University
2018-05-29
NCT02551029 COMPLETED
Irritable Bowel Syndrome; Colonic Diseases, Functional; Dyspepsia; Gastrointestinal Diseases; Abdominal Pain; Visceral Pain
Maastricht University Medical Center
2016-02
NCT02822625 COMPLETED
Pain
Institut de Cancérologie de Lorraine
2016-08-30 PHASE3
NCT03152578 COMPLETED
Pain
Panag Pharma Inc.
2017-07-01 PHASE2
NCT03611608 COMPLETED
Healthy
Eli Lilly and Company
2018-08-30 PHASE1
NCT03102710 COMPLETED
Pain
Massachusetts General Hospital
2016-05
NCT03122145 COMPLETED
Healthy
University of Florida
2017-05-23 PHASE1; PHASE2
NCT04052178 COMPLETED
Swallowing Disorder; Dysphagia; Stroke; Neurophysiologic Abnormality
Hospital de Mataró
2016-02-10
NCT02288156 COMPLETED
Non-allergic Rhinitis
Universitaire Ziekenhuizen KU Leuven
2015-07 PHASE4
NCT05029297 COMPLETED
Diabetic Neuropathy, Painful
Arafarma Group, S.A.
2010-11-04 PHASE3
NCT03146689 COMPLETED
Osteoarthritis, Knee
University of Nottingham
2017-08-04
NCT03528369 COMPLETED
Osteoarthritis, Knee; Pain
Propella Therapeutics
2018-05-14 PHASE2
NCT03576508 COMPLETED
Knee Osteoarthritis
Centrexion Therapeutics
2018-06-25 PHASE1
NCT03472677 COMPLETED
Osteoarthritis, Knee
Centrexion Therapeutics
2018-03-21 PHASE1
NCT03216707 COMPLETED
Pain
Assiut University
2017-09-01
NCT03281941 UNKNOWN
Asthma Chronic, Cough
National Health Service, United Kingdom
2016-08-06
NCT02710162 COMPLETED
Amyotrophic Lateral Sclerosis
University of Florida
2016-04 EARLY_PHASE1
NCT03153813 TERMINATED
Pain
Nadine ATTAL
2015-07 PHASE3
NCT02710110 COMPLETED
Amyotrophic Lateral Sclerosis
University of Florida
2016-04 EARLY_PHASE1
NCT03132142 UNKNOWN
Pain; Pruritus; Neuropathic Pain; Dermatology/Skin - Other
Aalborg University
2017-04
NCT02700815 COMPLETED
Acute Pain
Boehringer Ingelheim
2016-05-09 PHASE3
NCT03489226 COMPLETED
Energy Metabolism; Eating; Hunger
Pennington Biomedical Research Center
2016-05-02
NCT03074162 COMPLETED
Healthy
Boehringer Ingelheim
2017-04-20 PHASE1
NCT03113448 COMPLETED
Peripheral Diabetic Neuropathy
Thammasat University
2017-01-19 PHASE3
NCT02823912 UNKNOWN
Dyslipidemia; Overweight or Obesity
University of Guadalajara
2016-10 PHASE2; PHASE3
NCT02390089 COMPLETED
Parkinson's Disease
University of Florida
2015-04 PHASE1
NCT02603783 COMPLETED
TRPV1 Protein, Human; Capsaicin; Electric Impedance; Esophagus; Intracellular Space; Pain Measurement; Microscopy, Electron
Maastricht University Medical Center
2015-11
NCT02766517 COMPLETED
Migraine Disorders
Eli Lilly and Company
2016-09-28 EARLY_PHASE1
NCT02334605 UNKNOWN
Nasal Hyper Reactivity
Universitaire Ziekenhuizen KU Leuven
2015-01
NCT02377180 COMPLETED
Healthy
Insel Gruppe AG, University Hospital Bern
2014-09
NCT03124407 COMPLETED
Osteoarthritis, Knee
Propella Therapeutics
2016-07 PHASE4
NCT02537951 COMPLETED
Small Fiber Neuropathy
Erasmus Medical Center
2015-09
NCT02769910 COMPLETED
Pruritus
Hjalte Holm Andersen
2016-05 PHASE1; PHASE2
NCT02678416 COMPLETED
Pain
Mallinckrodt
2015-12-07 PHASE4
NCT02037464 UNKNOWN
Prostate Cancer
Sunnybrook Health Sciences Centre
2014-01 PHASE2
NCT01777087 COMPLETED
Pain
University of Pittsburgh
2013-01
NCT01541436 COMPLETED
Pain
Wake Forest University Health Sciences
2012-03 EARLY_PHASE1
NCT02138630 WITHDRAWN
Metabolism; Exercise
University of Prince Edward Island
2014-06
NCT02183519 COMPLETED
Cough; Parkinson's Disease
University of Florida
2014-10 PHASE1; PHASE2
NCT02346916 COMPLETED
Chest Pain
Bassett Healthcare
2013-10
NCT02346903 COMPLETED
Chest Pain
Bassett Healthcare
2013-04
NCT02533076 COMPLETED
Cystinosis
Universitaire Ziekenhuizen KU Leuven
2014-11 EARLY_PHASE1
NCT02240329 COMPLETED
TBI; Brain Injury
University of Florida
2013-03 EARLY_PHASE1
NCT02570841 COMPLETED
Pain
Medical University of Vienna
2015-02 PHASE4
NCT02233699 COMPLETED
Chronic Idiopathic Cough
Xention Ltd
2014-07 PHASE2
NCT01981395 COMPLETED
Hyperalgesia; Allodynia
Laura Cavallone
2014-01 PHASE1
NCT02233686 COMPLETED
Chronic Obstructive Pulmonary Disease
Xention Ltd
2014-02 PHASE2
NCT01862523 COMPLETED
Rhinitis
Universitaire Ziekenhuizen KU Leuven
2012-02 PHASE4
NCT01854268 COMPLETED
Cough
University of Florida
2013-05 PHASE1; PHASE2
NCT01533428 COMPLETED
Diabetic Peripheral Neuropathy; Pain
Astellas Pharma Inc
2012-02 PHASE3
NCT01963910 COMPLETED
Pain
University of British Columbia
2013-12
NCT01704339 UNKNOWN
End Stage Renal Failure; Neuropathic Pain
Emma Aitken
2012-12 PHASE4
NCT02882555 COMPLETED
Cough
Central Hospital, Nancy, France
2012-06
NCT01807832 UNKNOWN
Chronic Cough
Tel-Aviv Sourasky Medical Center
2013-03
NCT01575106 COMPLETED
Pain
Massachusetts General Hospital
2012-06
NCT01125215 UNKNOWN
Painful Diabetic Neuropathy
Mahidol University
2009-09 PHASE2; PHASE3
NCT01974037 COMPLETED
Volunteers
Zhiming Zhu
2013-05 PHASE4
NCT01699854 TERMINATED
Persistent Pain After Inguinal Herniotomy
Rigshospitalet, Denmark
2012-08 PHASE3
NCT01797796 COMPLETED
Healthy
Pfizer
2013-04 PHASE1
NCT01883102 COMPLETED
Pain
Mayo Clinic
2013-06 PHASE1
NCT01615510 TERMINATED
Pain; Hyperalgesia; Allodynia
University Hospital Schleswig-Holstein
2012-10 PHASE1
NCT01673529 COMPLETED
Dermatitis, Atopic
GlaxoSmithKline
2012-07-17 PHASE1
NCT01483846 COMPLETED
Neuropathic Pain
VistaGen Therapeutics, Inc.
2011-12 PHASE1
NCT00947284 TERMINATED
Healthy
University of California, San Francisco
2010-01
NCT01595620 COMPLETED
Pain
Yale University
2011-11-09 EARLY_PHASE1
NCT01884116 COMPLETED
Myofascial Pain Syndrome of the Upper Trapezius
Yonsei University
2011-03
NCT01231750 TERMINATED
Stable Angina
Neal Weintraub
2010-10 PHASE3
NCT02695745 COMPLETED
Pain
Purdue Pharma LP
2011-09 PHASE1
NCT01260454 COMPLETED
Pulmonary Hypertension; Pulmonary Arterial Hypertension
University of Rochester
2010-11 PHASE2
NCT00993070 COMPLETED
Diabetic Polyneuropathy
Thammasat University
2009-10 PHASE2; PHASE3
NCT01476098 COMPLETED
Rhinitis
GlaxoSmithKline
2011-04 PHASE2
NCT01147432 COMPLETED
Healthy
Pfizer
2010-08 PHASE1
NCT01223820 COMPLETED
Idiopathic Rhinitis Patients; Healthy Controls
Universitaire Ziekenhuizen KU Leuven
2011-01 PHASE4
NCT01228838 COMPLETED
Postherpetic Neuralgia; Pain
NeurogesX
2010-10 PHASE2
NCT01540877 COMPLETED
Ipsi- and Contralateral Hypoesthesia
Ruhr University of Bochum
2011-04
NCT00693407 COMPLETED
Functional Dyspepsia
National University Hospital, Singapore
2008-09
NCT00771511 WITHDRAWN
Labor Pain; Pregnancy Loss; Labor Induction
Columbia University
2010-10 PHASE4
NCT01667523 COMPLETED
Healthy
Maastricht University Medical Center
2011-02
NCT02228928 COMPLETED
Peripheral Nerve Injury; Postherpetic Neuralgia
Samyang Biopharmaceuticals Corporation
2009-02 PHASE1; PHASE2
NCT01200745 UNKNOWN
Chronic Neck Pain
Kyunghee University Medical Center
2010-09
NCT00795106 WITHDRAWN
Myofascial Pain Syndrome
Stamford Hospital
2009-11 PHASE2
NCT00693160 TERMINATED
Healthy
Wake Forest University
2007-12 PHASE2
NCT00875537 COMPLETED
Burning Mouth Syndrome
University of Copenhagen
2009-01
NCT01439308 COMPLETED
Rhinitis
GlaxoSmithKline
2009-12 PHASE2
NCT00962663 COMPLETED
Healthy
Pfizer
2009-08 PHASE1
NCT00886106 UNKNOWN
Hyperalgesia
Medical University of Vienna
2009-06 PHASE4
NCT00789386 UNKNOWN
Hyperalgesia
Medical University of Vienna
2008-11 PHASE4
NCT00916942 COMPLETED
Postherpetic Neuralgia
NeurogesX
2009-06 PHASE2
NCT00731250 COMPLETED
Rhinitis
GlaxoSmithKline
2008-07-22 PHASE1
NCT00683267 TERMINATED
Arthroplasty
Anesiva, Inc.
2007-09 PHASE2
NCT00672568 TERMINATED
Rotator Cuff Repair of the Shoulder
Anesiva, Inc.
2008-07 PHASE2
NCT00655811 COMPLETED
Healthy
Wake Forest University
2008-02 PHASE4
NCT00692601 COMPLETED
Healthy
Hamilton Health Sciences Corporation
2008-04 PHASE1
NCT00692146 COMPLETED
Capsaicin Evoked Pain; Heat Sensitivity
AstraZeneca
2008-01 PHASE1
NCT00321672 COMPLETED
Pain; HIV Infections; Peripheral Nervous System Diseases
NeurogesX
2006-06 PHASE3
NCT00471055 COMPLETED
Osteoarthritis, Knee Joint; Capsicum
Khon Kaen University
2007-06 PHASE3
NCT00004316 COMPLETED
Interstitial Cystitis; Vulvar Diseases
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1995-06 PHASE1; PHASE2
NCT00697034 TERMINATED
Psoriasis
Wake Forest University
2006-06 PHASE4
NCT00003610 COMPLETED
Head and Neck Cancer; Radiation Toxicity
Alliance for Clinical Trials in Oncology
1998-10 PHASE3
NCT00061776 COMPLETED
Herpes Zoster; Neuralgia; Pain; Peripheral Nervous System Diseases; Shingles
NeurogesX
PHASE2; PHASE3
NCT00061152 UNKNOWN
HIV Infections
NeurogesX
PHASE2
NCT00089557 TERMINATED
Herpes Zoster; Neuralgia; Pain; HIV Infections; Peripheral Nervous System Diseases; Diabetic Neuropathies; Diabetes Mellitus; Polyneuropathies
NeurogesX
PHASE2
NCT00233155 COMPLETED
Herpes Zoster; Neuralgia; Pain; HIV Infections; Peripheral Nervous System Diseases
NeurogesX
2005-08 PHASE2
NCT00176969 COMPLETED
Alopecia Areata
University of Minnesota
1997-08 PHASE4
NCT00088686 COMPLETED
Healthy; Tooth Extraction
National Institute of Dental and Craniofacial Research (NIDCR)
2004-07 PHASE2
NCT00082316 COMPLETED
Herpes Zoster; Neuralgia; Pain; HIV Infections; Peripheral Nervous System Diseases; Diabetic Neuropathies; Diabetes Mellitus; Polyneuropathies
NeurogesX
PHASE2
NCT00912262 COMPLETED
Pain
NeurogesX
2008-06 PHASE1
NCT00373893 COMPLETED
Pain; Hyperalgesia
University of California, San Diego
2005-12 PHASE1
NCT00008476 COMPLETED
Facial Pain
National Institute of Dental and Craniofacial Research (NIDCR)
2001-01 PHASE2
NCT00085761 TERMINATED
HIV Infections; Peripheral Nervous System Diseases; Pain
NeurogesX
PHASE3
NCT00064623 COMPLETED
HIV Infections; Peripheral Nervous System Diseases; Pain
NeurogesX
2003-08 PHASE3
NCT00528216 COMPLETED
Pain
NeurogesX
PHASE1
NCT00034710 COMPLETED
Neuralgia; Pain; Peripheral Nervous System Diseases; Herpes Zoster
NeurogesX
2002-03 PHASE2
NCT00068081 COMPLETED
Herpes Zoster; Neuralgia; Pain; Peripheral Nervous System Diseases
NeurogesX
PHASE3

(data from https://clinicaltrials.gov, updated on 2024-08-21)

Check the Capsaicin(Vanilloid) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Capsaicin acts as a selective agonist of the transient receptor potential vanilloid 1 (TRPV1) receptor, triggering intracellular calcium ion influx and subsequent desensitization of nociceptive primary sensory neurons. This receptor activation and prolonged neuronal refractory state suppress the transmission of pain signals, mediating analgesia in clinical conditions such as peripheral neuropathic pain and painful diabetic neuropathy.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.