Clofazimine 300 mg

National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2 active Small molecule Quality 0/100

Clofazimine 300 mg is a Small molecule drug developed by National Institute of Allergy and Infectious Diseases (NIAID). It is currently in Phase 2 development. Also known as: CFZ.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

• Baseline phase 2 → approval rate +15.3pp
  Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Clofazimine 300 mg
Also known as	CFZ
Sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

• Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial (PHASE2)
• Ultra-Short Course Bedaquiline, Clofazimine, Pyrazinamide and Delamanid Versus Standard Therapy for Drug-Susceptible TB (PHASE2)
• Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum
• Clofazimine- and Rifapentine-Containing Treatment Shortening Regimens in Drug-Susceptible Tuberculosis: The CLO-FAST Study (PHASE2)
• Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (PHASE2, PHASE3)
• Linezolid Dosing Strategies in Drug-Resistant TB (PHASE2)
• Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine to Treat MDR-TB (PHASE2)
• Evaluating Newly Approved Drugs in Combination Regimens for Multidrug-Resistant TB With Fluoroquinolone Resistance (endTB-Q) (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Clofazimine 300 mg CI brief — competitive landscape report
• Clofazimine 300 mg updates RSS · CI watch RSS
• National Institute of Allergy and Infectious Diseases (NIAID) portfolio CI

Frequently asked questions about Clofazimine 300 mg

What is Clofazimine 300 mg?

Clofazimine 300 mg is a Small molecule drug developed by National Institute of Allergy and Infectious Diseases (NIAID).

Who makes Clofazimine 300 mg?

Clofazimine 300 mg is developed by National Institute of Allergy and Infectious Diseases (NIAID) (see full National Institute of Allergy and Infectious Diseases (NIAID) pipeline at /company/national-institute-of-allergy-and-infectious-diseases-niaid).

Is Clofazimine 300 mg also known as anything else?

Clofazimine 300 mg is also known as CFZ.

What development phase is Clofazimine 300 mg in?

Clofazimine 300 mg is in Phase 2.

Related

• Manufacturer: National Institute of Allergy and Infectious Diseases (NIAID) — full pipeline
• Also known as: CFZ