Qutenza(capsaicin)
Qutenza (capsaicin) is a small molecule pharmaceutical. Capsaicin was first approved as Qutenza on 2009-05-15. It is used to treat diabetic neuropathies, herpes zoster, and neuralgia in the USA. It has been approved in Europe to treat neuralgia. The pharmaceutical is active against transient receptor potential cation channel subfamily V member 1. In addition, it is known to target cystic fibrosis transmembrane conductance regulator, transient receptor potential cation channel subfamily V member 6, potassium voltage-gated channel subfamily C member 1, potassium voltage-gated channel subfamily A member 7, potassium voltage-gated channel subfamily A member 2, and potassium voltage-gated channel subfamily A member 1.
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Commercial
Trade Name
FDA
EMA
Qutenza
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Capsaicin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| QUTENZA | Averitas Pharma | N-022395 RX | 2009-11-16 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| leader capsaicin pain relief cream | OTC monograph not final | 2023-06-08 |
| qutenza | New Drug Application | 2020-10-21 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| diabetic neuropathies | EFO_1000783 | D003929 | — |
| herpes zoster | EFO_0006510 | D006562 | B02 |
| neuralgia | EFO_0009430 | D009437 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
CAPSAICIN, QUTENZA, AVERITAS | |||
| 2023-07-17 | I-838 | ||
ATC Codes
M: Musculo-skeletal system drugs
— M02: Topical products for joint and muscular pain
— M02A: Topical products for joint and muscular pain
— M02AB: Capsaicin and similar agents
— M02AB01: Capsaicin
N: Nervous system drugs
— N01: Anesthetics
— N01B: Local anesthetics
— N01BX: Other local anesthetics in atc
— N01BX04: Capsaicin
HCPCS
Code | Description |
|---|---|
| J7336 | Capsaicin 8% patch, per square centimeter |
Clinical
Clinical Trials
177 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pain | D010146 | EFO_0003843 | R52 | 6 | 9 | 10 | 1 | 5 | 30 |
| Neuralgia | D009437 | EFO_0009430 | 1 | 6 | 4 | 2 | 7 | 19 | |
| Healthy volunteers/patients | — | 6 | 3 | — | 1 | 5 | 14 | ||
| Diabetic neuropathies | D003929 | EFO_1000783 | — | 4 | 6 | 2 | — | 10 | |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | 2 | 1 | 3 | 1 | 1 | 8 |
| Postherpetic neuralgia | D051474 | 1 | 3 | — | 3 | — | 6 | ||
| Peripheral nerve injuries | D059348 | 1 | 1 | — | 2 | — | 3 | ||
| Exercise | D015444 | EFO_0000483 | 1 | — | — | 1 | — | 2 | |
| Central nervous system sensitization | D059333 | 1 | — | — | 1 | — | 2 | ||
| Motor disorders | D000068079 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Peripheral nervous system diseases | D010523 | G64 | — | 5 | 7 | — | 1 | 12 | |
| Herpes zoster | D006562 | EFO_0006510 | B02 | — | 5 | 4 | — | — | 8 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 4 | 3 | — | — | 7 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | 1 | — | 1 | 2 |
| Head and neck neoplasms | D006258 | — | 1 | 1 | — | — | 2 | ||
| Acute pain | D059787 | R52 | — | — | 1 | — | 1 | 2 | |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | 1 | 1 | — | — | 2 |
| Vulvodynia | D056650 | N94.81 | — | 1 | 1 | — | — | 1 | |
| Dyslipidemias | D050171 | HP_0003119 | — | 1 | 1 | — | — | 1 | |
| Overweight | D050177 | E66.3 | — | 1 | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cough | D003371 | HP_0012735 | R05 | 4 | 2 | — | — | 4 | 8 |
| Deglutition disorders | D003680 | HP_0002015 | R13.1 | — | 1 | — | — | 5 | 6 |
| Pruritus | D011537 | HP_0000989 | L29 | 1 | 1 | — | — | 2 | 3 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | 2 | 1 | — | — | 1 | 3 |
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | — | 2 | — | — | — | 2 |
| Myofascial pain syndromes | D009209 | EFO_1001054 | — | 1 | — | — | 1 | 2 | |
| Postoperative pain | D010149 | G89.18 | — | 2 | — | — | — | 2 | |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | 2 | — | — | — | 2 |
| Polyneuropathies | D011115 | EFO_0009562 | A69.22 | — | 2 | — | — | — | 2 |
| Morton neuroma | D000070607 | G57.6 | — | 2 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Stroke | D020521 | EFO_0000712 | I63.9 | 1 | — | — | — | 3 | 4 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | 2 | — | — | — | 1 | 3 |
| Amyotrophic lateral sclerosis | D000690 | EFO_0000253 | G12.21 | 2 | — | — | — | 1 | 3 |
| Metabolism | D008660 | GO_0008152 | 2 | — | — | — | — | 2 | |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 1 | — | — | — | — | 1 |
| Cluster headache | D003027 | HP_0012199 | G44.00 | 1 | — | — | — | — | 1 |
| Trigeminal autonomic cephalalgias | D051303 | 1 | — | — | — | — | 1 | ||
| Paroxysmal hemicrania | D051302 | EFO_1001822 | G44.03 | 1 | — | — | — | — | 1 |
| Cystinosis | D003554 | E72.04 | 1 | — | — | — | — | 1 | |
| Brain injuries | D001930 | S06.9 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hyperalgesia | D006930 | — | — | — | — | 2 | 2 | ||
| Chest pain | D002637 | HP_0100749 | R07.9 | — | — | — | — | 2 | 2 |
| Burning mouth syndrome | D002054 | EFO_1000850 | — | — | — | — | 2 | 2 | |
| Headache | D006261 | HP_0002315 | R51 | — | — | — | — | 1 | 1 |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | — | — | — | — | 1 | 1 |
| Tendinopathy | D052256 | EFO_1001434 | M77.9 | — | — | — | — | 1 | 1 |
| Synovitis | D013585 | EFO_0008997 | M67.5 | — | — | — | — | 1 | 1 |
| Spasm | D013035 | M62.83 | — | — | — | — | 1 | 1 | |
| Radiculopathy | D011843 | M54.1 | — | — | — | — | 1 | 1 | |
| Gout | D006073 | EFO_0004274 | M10 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | CAPSAICIN |
| INN | capsaicin |
| Description | Capsaicin is a capsaicinoid. It has a role as a non-narcotic analgesic, a voltage-gated sodium channel blocker and a TRPV1 agonist. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | COc1cc(CNC(=O)CCCC/C=C/C(C)C)ccc1O |
Identifiers
| PDB | 7VEK |
| CAS-ID | 404-86-4 |
| RxCUI | 1992 |
| ChEMBL ID | CHEMBL294199 |
| ChEBI ID | 3374 |
| PubChem CID | 1548943 |
| DrugBank | DB06774 |
| UNII ID | S07O44R1ZM (ChemIDplus, GSRS) |
Target
Agency Approved
TRPV1
TRPV1
Organism
Homo sapiens
Gene name
TRPV1
Gene synonyms
VR1
NCBI Gene ID
Protein name
transient receptor potential cation channel subfamily V member 1
Protein synonyms
Capsaicin receptor, Osm-9-like TRP channel 1, OTRPC1, transient receptor potential vanilloid 1a, transient receptor potential vanilloid 1b, Vanilloid receptor 1, vanilloid receptor subtype 1
Uniprot ID
Mouse ortholog
Trpv1 (193034)
transient receptor potential cation channel subfamily V member 1 (Q704Y3)
Alternate
CFTR
CFTR
TRPV6
TRPV6
KCNC1
KCNC1
KCNA7
KCNA7
KCNA2
KCNA2
KCNA1
KCNA1
Organism
Homo sapiens
Gene name
CFTR
Gene synonyms
ABCC7
NCBI Gene ID
Protein name
cystic fibrosis transmembrane conductance regulator
Protein synonyms
ATP-binding cassette sub-family C member 7, cAMP-dependent chloride channel, Channel conductance-controlling ATPase, cystic fibrosis transmembrane conductance regulating, cystic fibrosis transmembrane conductance regulator (ATP-binding cassette sub-family C, member 7)
Uniprot ID
Mouse ortholog
Cftr (12638)
cystic fibrosis transmembrane conductance regulator (Q9JKQ6)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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240 adverse events reported
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