Benzydamine

Summary

Benzydamine (CHEMBL12610) is an approved small-molecule central nervous system stimulant (ATC G02CC03); indicated across 5 conditions including rheumatic disorder and vaginitis.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Small molecule
• ATC class: G02CC03 (+4 more)
• Indications: 5 conditions
• Clinical trials: 9
• Chemistry: 309.4 Da · C19H23N3O

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL12610
Name	Benzydamine
Type	Small molecule
Max phase	4
FDA approved	no
PubChem CID	12555
ChEBI	CHEBI:94563
ATC	G02CC03, M01AX07, M02AA05, A01AD02, R02AX03
Molecular formula	C19H23N3O
Molecular weight	309.4
InChIKey	CNBGNNVCVSKAQZ-UHFFFAOYSA-N

SMILES: CN(C)CCCOC1=NN(C2=CC=CC=C21)CC3=CC=CC=C3

IUPAC name: 3-(1-benzylindazol-3-yl)oxy-N,N-dimethylpropan-1-amine

ChEBI definition: A member of the class of indazoles carrying benzyl and 3-(dimethylamino)propyl groups at positions 1 and 3 respectively. A locally-acting nonsteroidal anti-inflammatory drug that also exhibits local anaesthetic and analgesic properties.

Pharmacological roles (ChEBI): central nervous system stimulant, non-steroidal anti-inflammatory drug, hallucinogen, local anaesthetic, analgesic.

Also known as: Apo-benzydamine, Bencidamina, Benzindamine, Benzydamine, SID11112291, benzydamine, SID160657813, BENZYDAMINE

Parent form; salt/anhydrous children: CHEMBL1528134

Patent coverage: 2,428 distinct patent families (8,193 SureChEMBL compound mentions), from 2 matched compound structure(s). One matched structure accounts for 8,077 (99%) of the total. Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

Broader ChEMBL bioactivity targets: 17 (assay-derived). Sample: Lysine-specific demethylase 4E, Alpha-2A adrenergic receptor, D(1A) dopamine receptor, Muscarinic acetylcholine receptor M2, Soluble guanylate cyclase, 5-hydroxytryptamine receptor 1A, Muscarinic acetylcholine receptor M1, Sodium-dependent noradrenaline transporter, Sodium-dependent serotonin transporter, Alpha-1A adrenergic receptor, Mu-type opioid receptor, D(3) dopamine receptor, Sodium-dependent dopamine transporter, Voltage-gated inwardly rectifying potassium channel KCNH2, Histamine H3 receptor, Cytochrome P450 2D6, Cytochrome P450 1A2.

Bioactivity

ChEMBL activities: 14 potent at pChembl ≥ 5 of 18 total. Top 100 by potency (10 = 0.1 nM, 6 = 1 µM):

Target	pChembl	Type	Value	Unit	Activity ID
SLC6A3	6.95	AC50	112.7	nM	CHEMBL_ACT_25124695
DRD3	6.3	AC50	499.6	nM	CHEMBL_ACT_25194265
GUCY1B2	5.99	EC50	1020	nM	CHEMBL_ACT_705412
SLC6A2	5.68	AC50	2094	nM	CHEMBL_ACT_25145736
CHRM1	5.64	AC50	2297	nM	CHEMBL_ACT_25209980
HTR1A	5.61	AC50	2431	nM	CHEMBL_ACT_25164760
CHRM2	5.48	AC50	3317	nM	CHEMBL_ACT_25195472
DRD1	5.38	AC50	4118	nM	CHEMBL_ACT_25114946
ADRA2A	5.38	AC50	4170	nM	CHEMBL_ACT_25156165
CYP1A2	5.3	AC50	5012	nM	CHEMBL_ACT_6038646
KCNH2	5.23	AC50	5900	nM	CHEMBL_ACT_25117155
CYP2D6	5.1	Potency	7943	nM	CHEMBL_ACT_5006407
CYP2D6	5.1	AC50	7943	nM	CHEMBL_ACT_6041839
SLC6A4	5.09	AC50	8185	nM	CHEMBL_ACT_25151063

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

2 approved indications. FDA phase 4, plus an anticancer drug’s labelled cancer uses (which ChEMBL often logs at phase 3).

Indication	Phase	MONDO	EFO
rheumatic disorder	4	MONDO:0005554	EFO:0005755
vaginitis	4	MONDO:0002234	EFO:0005757

1 disease in clinical trials (phase 1–3, investigational — not approved indications). Highest ChEMBL trial phase per disease; a non-cancer approved use is occasionally logged at phase 3 here.

Disease (in trials)	Phase	MONDO	EFO
stomatitis	3	MONDO:0004842	EFO:1001904

2 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 9.

Phase distribution

Phase	Trials
PHASE4	4
PHASE1/PHASE2	2
Not specified	2
PHASE3	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT03745599	PHASE4	COMPLETED	Evaluation of the Effects of Different Analgesics on Pericoronitis Pain and Quality of Life
NCT05055726	PHASE4	COMPLETED	Benzydamine Oromucosal Solution in Oral Mucositis (BOOM)
NCT06879366	PHASE4	COMPLETED	Evaluation of the Efficacy of Aloe-Vera el Versus Bezydamine Hydrochloride in the Prevention of Radiation Induced Oral Mucositis A Randamized Controlled Clinical Trial
NCT07565766	PHASE4	COMPLETED	Effect of Benzydamine Hydrochloride Mouthrinse on Plaque Accumulation in Periodontally Healthy Female Subjects
NCT00051441	PHASE3	COMPLETED	Safety & Efficacy Study of Benzydamine Oral Rinse for the Treatment of Oral Mucositis (Mouth Sores) Resulting From Radiation Therapy for Cancer of the Oral Cavity, Oropharynx, or Nasopharynx
NCT05338398	PHASE1/PHASE2	UNKNOWN	Study for the Prevention of Oral Mucositis (SPOM)
NCT06862817	PHASE1/PHASE2	COMPLETED	Comparison Between the Effect of Aloe Vera and Benzydamine Hydrochloride Mouth Gel on Prevention of Pain and Progression of Radiation-induced Oral Mucositis
NCT04167592	Not specified	COMPLETED	Benzydamine Hydrochloride Gargle in Reducing Propofol for ERCP
NCT05640362	Not specified	COMPLETED	Efficacy of Natural Enzymes Mouthwash: a Randomised Controlled Trial

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No CPIC/DPWG dosing guideline or drug-level clinical/variant annotations in PharmGKB for this molecule.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).