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Aspercreme Warming

(Capsaicin)

ApprovedSmall molecule

AAveritas Pharma, Inc.

This topical cream or ointment contains capsaicin, a substance from chili peppers that helps relieve minor muscle and joint pain from arthritis, strains, and bruises by reducing pain signals in nerve cells under the skin.[2] Aspercreme Warming is currently approved and in use across 43 indications[4].[1]

Aspercreme Warming is one of 607 small molecule programs targeting Myofascial Pain Syndrome. It is currently in Approved.

43

Indications

57

Total Trials

4

Active Trials

606

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

2

Patents

Pipeline

Status by Indication[4][1]

Indication

Myofascial Pain SyndromeApproved

HIV InfectionApproved

Muscle SpasmActive, not recruiting

Cardiovascular DiseaseApproved

Migraine DisorderApproved

ArthritisActive, not recruiting

Morton NeuromaApproved

Complex Regional Pain SyndromeApproved

StrokeApproved

Peripheral NeuropathyRecruiting

Myofascial Pain SyndromeApproved

Approved

HIV InfectionApproved

Approved

Muscle SpasmApproved

Active, not recruiting

Cardiovascular DiseaseApproved

Approved

Migraine DisorderApproved

Approved

ArthritisApproved

Active, not recruiting

Morton NeuromaApproved

Approved

Complex Regional Pain SyndromeApproved

Approved

StrokeApproved

Approved

Peripheral NeuropathyPhase 3

Recruiting

Showing 10 of 40 indications

Competition

Competitive Landscape

147 competitors in Cardiovascular Disease

#DrugCompanyPhaseTrials

Aspercreme Warming

AAveritas Pharma, Inc.

Niacor

Lescol

Adenocard

Timolol Maleate

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Brevibloc

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Betapace

LLegacy Health System

Colcrys

Jazz Pharmaceuticals

Pelacarsen

Cagrilintide

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 3Recruiting

Peripheral Neuropathy

NCT05840562

Q2 2027

Coccyx Disorder

NCT05983263

Clinical

Trials by Indication[1]

Rhinitis4 trials

Mechanisms of Capsaicin Treatment in Idiopathic Rhinitis Patients and Controls

Completed·UUniversitaire Ziekenhuizen KU Leuven·Phase 4·NCT01862523·39 enrolled

Neuro-immunological Analysis of Idiopathic Rhinitis Patients and Controls Treated With Capsaicin.

Completed·UUniversitaire Ziekenhuizen KU Leuven·Phase 4·NCT01223820·36 enrolled

Elaboration of Patient-friendly Treatment Strategy With Capsaicin Nasal Spray in Patients With Idiopathic Rhinitis

Completed·UUniversitaire Ziekenhuizen KU Leuven·Phase 4·NCT02288156·80 enrolled

Show 1 more trial

Intranasal Capsaicin Treatment for Non-Allergic Irritant Rhinitis

Completed·TThe University of Texas Health Science Center, Houston·Phase 2·NCT02493257·22 enrolled

Treatment3 trials

Capsaicin for the Treatment of Cannabinoid Hyperemesis Syndrome

Completed·UUniversity of Virginia·Phase 4·NCT04283292·20 enrolled

Capsaicin Patch 8 % for the Treatment of Persistent Pain After Inguinal Herniotomy

Terminated·RRigshospitalet, Denmark·Phase 3·NCT01699854·50 enrolled

A Study of the Effects of Topical Capsaicin in the Treatment of Provoked Vestibulodynia

Terminated·—·Phase 2/3·NCT02854670·10 enrolled

Chest pain2 trials

Chest Pain Perception and Capsaicin Sensitivity in Patients With Acute Cardiac Ischemia

Completed·BBassett Healthcare·N/A·NCT02346916·22 enrolled

Chest Pain Perception and Capsaicin Sensitivity

Completed·BBassett Healthcare·N/A·NCT02346903·99 enrolled

Amyotrophic Lateral Sclerosis2 trials

Respiratory Strength Training in Persons With Amyotrophic Lateral Sclerosis (ALS)

Completed·UUniversity of Florida·Phase 1·NCT02710110·50 enrolled

Accurate Screening Tools for Dysphagia in Amyotrophic Lateral Sclerosis (ALS)

Completed·UUniversity of Florida·Phase 1·NCT02710162·21 enrolled

Diabetic Neuropathy2 trials

Efficacy and Safety Study of Topical Capsaicin in Painful Diabetic Neuropathy

Completed·TThammasat University·Phase 2/3·NCT00993070·33 enrolled

Study With Two Capsaicin Topic Treatments in Diabetic Neuropathy.

Completed·AArafarma Group, S.A.·Phase 3·NCT05029297·161 enrolled

37 more indications

Exercise2 trials

The Influence of Capsaicin Gel During Exercise Within the Heat

Completed·UUniversity of Nebraska·Phase 4·NCT05298202·12 enrolled

Effect of Muscular Exercise on Cough Reflex

Completed·—·N/A·NCT02882555·60 enrolled

Nausea and vomiting2 trials

Capsaicin to Prevent Delayed Chemotherapy Induced Nausea and Vomiting (CapCIN)

Completed·—·Phase 2·NCT04918069·160 enrolled

Capsaicin Cream as an Adjunctive Therapy for Nausea and Vomiting of Pregnancy

Completed·WWomen and Infants Hospital of Rhode Island·Phase 2·NCT05098067·30 enrolled

Function2 trials

Effects of Capsaicin on the Structure, Distribution, and Function of Cutaneous Small Nerve Fibers in Psoriatic Skin

Terminated·WWake Forest University·Phase 4·NCT00697034·12 enrolled

Sensory Function After Wound Instillation of Capsaicin

Completed·RRigshospitalet, Denmark··NCT00583180·42 enrolled

Osteoarthritis2 trials

Ibuprofen Gel or Capsaicin Cream for my Painful Knee Osteoarthritis?

Completed·UUniversity of Nottingham·N/A·NCT03146689·22 enrolled

Osteoarthritis Knee Pain Relief Study of 0.25% 920-CGS-200

Completed·PPropella Therapeutics·Phase 4·NCT03124407·120 enrolled

Third Molar2 trials

Capsaicin to Control Pain Following Third Molar Extraction

Completed·NNational Institute of Dental and Craniofacial Research (NIDCR)·Phase 2·NCT00088686·75 enrolled

Capsaicin to Control Pain Following Third Molar Extraction

Completed·NNational Institute of Dental and Craniofacial Research (NIDCR)·Phase 2·NCT00008476·162 enrolled

Cerebral Perfusion2 trials

Capsaicin for Cerebral Perfusion Augmentation.

Completed·JJuan Manuel Marquez Romero·Phase 1·NCT04545892·30 enrolled

Capsaicin for Cerebral Perfusion Augmentation

Completed·IInstituto Mexicano del Seguro Social·Phase 2·NCT05543837·20 enrolled

Experimental1 trial

Motor Unit Abnormalities After Experimentally Induced Sensitization

Completed·TToronto Rehabilitation Institute·Phase 4·NCT04361149·23 enrolled

CHOP1 trial

Ethnic Differences in Response to Topical Capsaicin: A Psychophysical Study on Healthy Subjects

Completed·WWake Forest University·Phase 4·NCT00655811·40 enrolled

Ischemic stroke1 trial

Safety of Transmucosal Capsaicin Sphenopalatine Ganglion Stimulation in Acute Ischemic Stroke

Recruiting·IInstituto Mexicano del Seguro Social·Phase 2·NCT07406971·46 enrolled

Microcirculation1 trial

Mechanisms of Human Cutaneous Microcirculation in Healthy Volunteers

Completed·UUniversity Hospital, Angers··NCT00152724·85 enrolled

Labor Induction1 trial

Cervical Capsaicin for Labor Induction and Pain Relief

Withdrawn·—·Phase 4·NCT00771511

Peripheral Neuropathy1 trial

Capsaicin 179 mg Patch Versus Oral Duloxetine in Patients With Chemotherapy-induced Peripheral Neuropathy

Recruiting·IInstitut Cancerologie de l'Ouest·Phase 3·NCT05840562·274 enrolled

Migraine1 trial

Biomarker Study in Participants With Migraine

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02766517·37 enrolled

Ketorolac1 trial

Effect of Spinal Ketorolac After Acute Opioid Exposure

Terminated·WWake Forest University·Phase 2·NCT00693160·30 enrolled

Interstitial Cystitis1 trial

Phase I/II Randomized, Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar Vestibulitis

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 1/2·NCT00004316·139 enrolled

Parkinson's Disease1 trial

Respiratory Kinematics of Cough in Healthy Older Adults and Parkinson's Disease

Completed·UUniversity of Florida·Phase 1/2·NCT02183519·44 enrolled

Neck pain1 trial

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

Withdrawn·SStamford Hospital·Phase 2·NCT00795106

Pain Control1 trial

Positron Emission Tomography to Measure Pain and Pain Control

Completed·NNational Institute of Dental and Craniofacial Research (NIDCR)··NCT00001307·273 enrolled

Neuropathic Pain1 trial

Evaluation in the Treatment of Neuropathic Pain Post Breast Surgery

Completed·IInstitut Cancerologie de l'Ouest·Phase 3·NCT03794388·140 enrolled

Alopecia Areata1 trial

Response of Topical Capsaicin in Alopecia Areata

Completed·UUniversity of Minnesota·Phase 4·NCT00176969·24 enrolled

Efficacy1 trial

Efficacy of Topical Capsaicin Cream for Stable Angina

Terminated·NNeal Weintraub·Phase 3·NCT01231750·7 enrolled

Acute Lymphoblastic Leukemia1 trial

Normal Breathing and Swallowing in Healthy Volunteers

Completed·UUniversity of Florida·Phase 1/2·NCT03122145·49 enrolled

Desensitization1 trial

Desensitization of Nociceptive Afferents by Application of Topical Capsaicin, Trans-cinnamaldehyde and L-menthol

Unknown status·—·N/A·NCT03132142·22 enrolled

Ultrasound1 trial

Quantitative Ultrasound Response of Capsaicin

Completed·TToronto Rehabilitation Institute·Phase 1·NCT03944889·20 enrolled

Dyslipidemia1 trial

Capsaicin Effect on Cytokines Profile in Dyslipidemia

Unknown status·UUniversity of Guadalajara·Phase 2/3·NCT02823912·17 enrolled

Back pain1 trial

Capsaicin + Diclofenac Gel in Acute Back Pain or Neck Pain

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT02700815·746 enrolled

Biomarker1 trial

Pain Biomarker Study

Enrolling by invitation·TThe University of Texas Health Science Center, Houston·Phase 1·NCT03511846·371 enrolled

Postherpetic Neuralgia1 trial

Pilot Study of High-Dose Capsaicin Patches to Treat Postherpetic Neuralgia Pain

Completed·NNeurogesX·Phase 2·NCT00034710·42 enrolled

Burning Mouth Syndrome1 trial

Burning Mouth Syndrome - New Diagnostic Criteria and Treatment

Unknown status·MMalmö University·N/A·NCT05059418·40 enrolled

Chronic Neck Pain1 trial

Efficacy of Topical Capsaicin on Chronic Neck Pain

Unknown status·KKyunghee University Medical Center·N/A·NCT01200745·60 enrolled

Pain1 trial

The Effect of Injection Site Cooling on Pain Experienced After the Administration of CNTX-4975-05 Into the Knee

Completed·CCentrexion Therapeutics·Phase 1·NCT03472677·20 enrolled

Morphine1 trial

Evaluation of Peripheral Itch Mechanisms Following Injection of Morphine (Second Sub-Project)

Completed·—·N/A·NCT04700007·26 enrolled

Chronic Cough1 trial

Functional Magnetic Resonance Imaging of ATP Cough in Chronic Cough Patients

Completed·SStuart Mazzone·N/A·NCT03722849·58 enrolled

Pain Threshold1 trial

Experimental Biomarker Study for Pain Thresholds

Completed·PPurdue Pharma LP·Phase 1·NCT02695745·37 enrolled

Imaging1 trial

A Study to Evaluate Laser Speckle Contrast Imaging to Assess Changes in Chemical Agent-Induced Skin Blood Flow in Healthy Participants (MK-0000-420)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT06809569·12 enrolled

Coccyx Disorder1 trial

Neuropathic Determining Factors and Analgesic Efficacy of Capsaicin 8% (QUTENZA®) Patches in Refractory Coccygodygnia

Recruiting·NNantes University Hospital··NCT05983263·106 enrolled

Unspecified2 trials

Airway Protective Mechanisms in PD (R01)

Completed·UUniversity of Florida··NCT03321019·119 enrolled

A Mechanistic Evaluation of the Nociceptive Desensitizing Properties of Topical Capsaicin

Completed·—·N/A·NCT03587220·44 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 16, 2009

QUTENZA

NDA NDA022395

Sources

References

[1]
ClinicalTrials.gov — 57 trial records for Capsaicin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Aspercreme Warming drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Capsaicin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Capsaicin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA022395). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Aspercreme Warming. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Averitas Pharma, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Vanilloid Receptor Opener[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AAveritas Pharma, Inc.

Patent Landscape[6]

Patent Cliff

Dec 15, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9226903Dec 15, 2028

8821920Mar 26, 2030

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