Clemastine
Clemastine, Tavist (clemastine) is a small molecule pharmaceutical. Clemastine was first approved as Tavist on 1982-01-01. It is used to treat allergic rhinitis perennial, angioedema, and urticaria in the USA. The pharmaceutical is active against histamine H1 receptor. In addition, it is known to target P2X purinoceptor 7.
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Commercial
Trade Name
FDA
EMA
Clemastine (discontinued: Clemastine, Tavist)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Clemastine fumarate
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| clemastine fumarate | ANDA | 2025-02-03 |
| clemsza | ANDA | 2025-07-30 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
D: Dermatologicals
— D04: Antipruritics, incl. antihistamines, anesthetics, etc.
— D04A: Antipruritics, incl. antihistamines, anesthetics, etc.
— D04AA: Antihistamines for topical use
— D04AA14: Clemastine
R: Respiratory system drugs
— R06: Antihistamines for systemic use
— R06A: Antihistamines for systemic use
— R06AA: Aminoalkyl ethers, systemic antihistamines
— R06AA04: Clemastine
— R06AA54: Clemastine, combinations
HCPCS
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Clinical
Clinical Trials
26 clinical trials
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | 3 | 5 | 1 | — | — | 6 |
| Sclerosis | D012598 | — | — | 2 | 3 | 1 | — | — | 4 |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | 1 | — | 1 | — | 1 | 3 |
| Dermatitis | D003872 | — | L30.9 | — | — | 2 | — | — | 2 |
| Syndrome | D013577 | — | — | — | — | 2 | — | — | 2 |
| Williams syndrome | D018980 | Orphanet_904 | Q93.82 | — | — | 2 | — | — | 2 |
| Eczema | D004485 | — | L30.9 | — | — | 1 | — | — | 1 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | — | 1 | — | — | 1 |
| Vasculitis | D014657 | EFO_0006803 | M31 | — | — | 1 | — | — | 1 |
| Anti-neutrophil cytoplasmic antibody-associated vasculitis | D056648 | — | I77.82 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | 1 | 2 | — | — | — | 2 |
| Chronic progressive multiple sclerosis | D020528 | EFO_0003840 | — | 2 | 2 | — | — | — | 2 |
| Tuberous sclerosis | D014402 | — | Q85.1 | 2 | 2 | — | — | — | 2 |
| Angioedema | D000799 | EFO_0005532 | T78.3 | — | 1 | — | — | — | 1 |
| Chronic urticaria | D000080223 | — | L50.8 | — | 1 | — | — | — | 1 |
| Urticaria | D014581 | EFO_0005531 | L50 | — | 1 | — | — | — | 1 |
| Neuritis | D009443 | — | — | — | 1 | — | — | — | 1 |
| Optic neuritis | D009902 | EFO_0007405 | H46 | — | 1 | — | — | — | 1 |
| Demyelinating diseases | D003711 | — | — | 1 | 1 | — | — | — | 1 |
| Marchiafava-bignami disease | D054319 | EFO_1001809 | G37.1 | 1 | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
| Autistic disorder | D001321 | EFO_0003758 | F84.0 | 1 | — | — | — | — | 1 |
| Autism spectrum disorder | D000067877 | — | F84.0 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anaphylaxis | D000707 | — | T78.2 | — | — | — | — | 1 | 1 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | — | — | — | 1 | 1 |
| Headache | D006261 | — | R51 | — | — | — | — | 1 | 1 |
| Migraine without aura | D020326 | EFO_0005296 | G43.0 | — | — | — | — | 1 | 1 |
| Graves ophthalmopathy | D049970 | EFO_1001466 | — | — | — | — | — | 1 | 1 |
| Graves disease | D006111 | EFO_0004237 | E05.0 | — | — | — | — | 1 | 1 |
| Exophthalmos | D005094 | — | H05.20 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Clemastine |
| INN | clemastine |
| Description | Clemastine is 2-[(2R)-1-Methylpyrrolidin-2-yl]ethanol in which the hydrogen of the hydroxy group is substituted by a 1-(4-chlorophenyl)-1-phenylethyl group (R configuration). An antihistamine with antimuscarinic and moderate sedative properties, it is used as its fumarate salt for the symptomatic relief of allergic conditions such as rhinitis, urticaria, conjunctivitis and in pruritic (severe itching) skin conditions. It has a role as a H1-receptor antagonist, an anti-allergic agent, a muscarinic antagonist and an antipruritic drug. It is a N-alkylpyrrolidine and a member of monochlorobenzenes. |
| Classification | Small molecule |
| Drug class | antihistaminics (histamine-H1 receptor antagonists) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CN1CCC[C@@H]1CCO[C@](C)(c1ccccc1)c1ccc(Cl)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 15686-51-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1626 |
| ChEBI ID | 3738 |
| PubChem CID | 26987 |
| DrugBank | DB00283 |
| UNII ID | 95QN29S1ID (ChemIDplus, GSRS) |
Target
Alternate
P2RX7
P2RX7
Organism
Homo sapiens
Gene name
P2RX7
Gene synonyms
NCBI Gene ID
Protein name
P2X purinoceptor 7
Protein synonyms
ATP receptor, P2X7 receptor, P2Z receptor, Purinergic receptor, purinergic receptor P2X, ligand gated ion channel, 7, purnergic receptor P2X 7
Uniprot ID
Mouse ortholog
P2rx7 (18439)
P2X purinoceptor 7 (Q9Z1M0)
Variants
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Financial
Revenue by drug
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Estimated US medical usage
Clemastine
Total medical expenditures per year (USD, in millions)
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Price per prescription (USD)
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Clemastine
+
Phenylpropanolamine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Price per prescription (USD)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,912 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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839 adverse events reported
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