Clemastine - PharmaKB

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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Target

Variants

Financial

Trends

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Events Timeline

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

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Completion date

Results first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
respiratory tract diseases	D012140
otorhinolaryngologic diseases	D010038
cardiovascular diseases	D002318
skin and connective tissue diseases	D017437
immune system diseases	D007154

Trade Name

FDA

EMA

Clemastine (discontinued: Clemastine, Tavist)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Clemastine fumarate

Tradename	Company	Number	Date	Products
TAVIST-1	GSK	N-020925 DISCN	1992-08-21	1 products, RLD
TAVIST	Novartis	N-017661 DISCN	1982-01-01	1 products, RLD
TAVIST-1	Novartis	N-017661 DISCN	1982-01-01	2 products
TAVIST	Novartis	N-018675 DISCN	1985-06-28	1 products, RLD

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Acetaminophen

Clemastine fumarate

Pseudoephedrine hydrochloride

Tradename	Company	Number	Date	Products
TAVIST ALLERGY/SINUS/HEADACHE	Novartis	N-021082 DISCN	2001-03-01	1 products

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FDA

EMA

Brand Name	Status	Last Update
clemastine fumarate	ANDA	2025-02-03

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
allergic rhinitis perennial	EFO_1001417	D012221	J30.89
urticaria	EFO_0005531	D014581	L50
angioedema	EFO_0005532	D000799	T78.3
pain	EFO_0003843	D010146	R52
fever	—	D005334	R50.9
sinusitis	EFO_0007486	D012852	J32
asthma	EFO_0000270	D001249	J45
common cold	EFO_0007214	D003139	J00

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

No data

Clinical

Clinical Trials

26 clinical trials

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Indications Phases 4

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Indications Phases 3

No data

Indications Phases 2

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hypersensitivity	D006967	EFO_0003785	T78.40	1	—	—	—	—	1

Indications Without Phase

No data

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

Agency Approved

HRH1

Organism

Homo sapiens

Gene name

HRH1

Gene synonyms

NCBI Gene ID

3269

Protein name

histamine H1 receptor

Protein synonyms

histamine receptor, subclass H1

Uniprot ID

Q6P9E5

Mouse ortholog

Hrh1 (15465)

histamine H1 receptor (Q91XN3)

Alternate

P2RX7

Organism

Homo sapiens

Gene name

P2RX7

Gene synonyms

NCBI Gene ID

5027

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

Q99572

Mouse ortholog

P2rx7 (18439)

P2X purinoceptor 7 (Q9Z1M0)

Variants

No data

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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Clemastine

Phenylpropanolamine

Total medical expenditures per year (USD, in millions)

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Trends

PubMed Central

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Additional graphs summarizing 1,814 documents

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Safety

Black-box Warning

No Black-box warning

Adverse Events

Top Adverse Reactions

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808 adverse events reported

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