Clofazimine

Antimycobacterial — ANTIINFECTIVES FOR SYSTEMIC USE

Key facts

Clofazimine is an ofm drug in the Antimycobacterial class catalogued in DrugCentral. It was first approved by the FDA in 1986. DrugCentral lists 4 molecular targets, including ABCG2, S and Cruzipain. Recorded indications include Dapsone resistant leprosy, Erythema nodosum leprosum, Leprosy and Multibacillary leprosy.

• Approval status: ofm (first approved 1986 by the FDA).
• Drug class: Antimycobacterial.
• Molecular targets: ABCG2, S, Cruzipain and Uncharacterized oxidoreductase CzcO-like (4 listed in DrugCentral).
• Indications: Dapsone resistant leprosy, Erythema nodosum leprosum, Leprosy, Multibacillary leprosy and Pyoderma gangrenosum.
• ATC code: J04BA01 (Drugs for treatment of lepra).
• Molecular formula: C27H22Cl2N4; molecular weight 473.40 g/mol.

Indications & contraindications

Drug–disease relationships curated by DrugCentral (OMOP / SNOMED concepts).

Indications (5)

• Dapsone resistant leprosy
• Erythema nodosum leprosum
• Leprosy
• Multibacillary leprosy
• Pyoderma gangrenosum

Off-label uses (1)

• Mycobacteriosis

Contraindications (8)

• Breastfeeding (mother)
• Diarrhea
• Disease of liver
• Disorder of digestive system
• Gastrointestinal hemorrhage
• Gastrointestinal obstruction
• Nausea and vomiting
• Splenic infarction

Mechanism & targets

• Established pharmacologic class: Antimycobacterial

Molecular targets (4)

Target	Gene	Action	Activity
ATP-binding cassette sub-family G member 2	ABCG2	unknown	IC50 5.50
Spike glycoprotein	S	unknown	Kd 5.42
Cruzipain	—	unknown	IC50 5.22
Uncharacterized oxidoreductase CzcO-like	—	unknown	—

Regulatory approvals (1)

Date	Agency	Marketed as	Applicant	Orphan
1986-12-15	FDA	—	NOVARTIS	Yes

ATC classification

ATC code	Therapeutic hierarchy
J04BA01	ANTIINFECTIVES FOR SYSTEMIC USE › ANTIMYCOBACTERIALS › DRUGS FOR TREATMENT OF LEPRA › Drugs for treatment of lepra
J04BA51	ANTIINFECTIVES FOR SYSTEMIC USE › ANTIMYCOBACTERIALS › DRUGS FOR TREATMENT OF LEPRA › Drugs for treatment of lepra

Reported adverse-event signals

Strongest FDA FAERS disproportionality signals (log-likelihood ratio). A signal is a statistical association in spontaneous reports, not proof that the drug causes the event.

MedDRA term	LLR
Electrocardiogram QT prolonged	1871.1
Drug resistance	580.6
Neuropathy peripheral	481.1
Type 2 lepra reaction	353.6
Hepatotoxicity	331.8
Anaemia	287.6
Ototoxicity	239.8
Off label use	180.2
Optic neuropathy	171.0
Mycobacterium avium complex infection	170.9
Skin discolouration	166.5
Drug reaction with eosinophilia and systemic symptoms	156.1

Chemical structure

Full physicochemical, ADMET and 3D-structure analysis of Clofazimine is on its molecule page.

• Molecular formula: C₂₇H₂₂Cl₂N₄
• Molecular weight: 473.40 g/mol
• CAS number: 2030-63-9
• InChIKey: WDQPAMHFFCXSNU-BGABXYSRSA-N
• PubChem CID: 2794

CC(C)\N=C1/C=C2N(C3=CC=C(Cl)C=C3)C3=CC=CC=C3N=C2C=C1NC1=CC=C(Cl)C=C1

Frequently asked questions

Answers are generated from the structured data on this page, not written by hand.

What is Clofazimine used for?

DrugCentral lists the following indications for Clofazimine: Dapsone resistant leprosy, Erythema nodosum leprosum, Leprosy, Multibacillary leprosy and Pyoderma gangrenosum.

How does Clofazimine work?

Its molecular targets in DrugCentral include ABCG2, S, Cruzipain and Uncharacterized oxidoreductase CzcO-like.

When was Clofazimine first approved?

Clofazimine was first approved by the FDA in 1986.

What drug class does Clofazimine belong to?

Clofazimine is in the Antimycobacterial class.

What is the chemical formula of Clofazimine?

Clofazimine has the molecular formula C27H22Cl2N4 and a molecular weight of 473.40 g/mol.

Sources

• DrugCentral drug card 692 — structure, indications, targets, approvals, pharmacologic classes (CC BY-SA 4.0)
• ChEMBL CHEMBL1292 — compound record and bioactivity
• PubChem CID 2794 — chemical identifiers
• DrugBank DB00845 — drug record
• FDA UNII D959AE5USF — substance identity
• DailyMed: FDA labels for Clofazimine — current prescribing information (label search)
• UniProt Q9UNQ0 (ABCG2) — target protein
• FDA Adverse Event Reporting System (openFDA FAERS) — adverse-event signals, as aggregated by DrugCentral

How this page is built: methodology · editorial policy & corrections.