Drugs / Clofazimine
Clofazimine
also known as
CFZ · Cfz-Clofazimine · Chlofazimine · CLF · Clofazimina · Clofaziminum · Colfazimine · G 30320 · +2 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | LAMPRENE | — | 1986-12-15 | fda.gov ↗ |
Trials 40
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2026-04-30 | RedHill Biopharma Limited | Results RedHill's RHB-204 Demonstrates Comparable MAP Killing Efficacy to RHB-104 - Important Step in RHB-204 Development for MAP-related Crohn's Disease redhillbio.com ↗ |
| 2025-11-10 | Mannkind Corporation | Results MannKind Provides Update on Phase 3 ICoN-1 Trial of Nebulized Clofazimine for NTM Lung Disease mannkindcorp.com ↗
Following an ad hoc meeting held on November 8, 2025, the independent Data Safety Monitoring Board (DSMB) reviewed the data and agreed with the decision to discontinue the trial due to futility. |
| 2024-09-18 | Mannkind Corporation | Regulatory MannKind Announces Clearance from PMDA to Initiate Phase 3 Clinical Trial (ICoN-1) in Japan Evaluating Clofazimine Inhalation Suspension for the Treatment of Nontuberculous Mycobacterial (NTM) Lung Disease mannkindcorp.com ↗
MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced today that it has received clearance from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to initiate the Phase 3 study (ICoN-1) of Clofazimine Inhalation Suspension for the treatment of NTM lung disease. |
| 2024-05-08 | Mannkind Corporation | Regulatory MannKind Corporation Reports 2024 First Quarter Financial Results: Provides Clinical Development Update mannkindcorp.com ↗
In the last week, we received Fast Track designation and clearance of the IND for MNKD-101 which may allow us to bring this innovative product to patients more quickly. |
| 2024-05-06 | Mannkind Corporation | Regulatory MannKind Receives U.S. FDA Fast Track Designation for Clofazimine Inhalation Suspension for the Treatment of Nontuberculous Mycobacterial (NTM) Lung Disease mannkindcorp.com ↗ |
| 2024-04-29 | Mannkind Corporation | Regulatory MannKind Announces IND Clearance From U.S. FDA to Start Phase 3 Study of Clofazimine Inhalation Suspension for Nontuberculous Mycobacterial (NTM) Lung Disease mannkindcorp.com ↗
the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for MNKD-101 (Clofazimine Inhalation Suspension), enabling the initiation of a Phase 3 study for the treatment of nontuberculous mycobacterial (NTM) lung disease. |
| 2023-01-23 | Mannkind Corporation | Results MannKind’s Inhaled Clofazimine Will Advance to an Adaptive Phase 2/3 Study For Potential Treatment of Rare Lung Disease mannkindcorp.com ↗
Paper published on clofazimine inhalation suspension demonstrates promising tolerability and toxicokinetics for treating pulmonary NTM infection |
| 2022-09-06 | Mannkind Corporation | Results Mannkind Successfully Completes Phase 1 Study of Inhaled Clofazimine mannkindcorp.com ↗
No serious adverse events or QT prolongation identified |
| 2021-01-06 | RedHill Biopharma Limited | Regulatory RedHill Biopharma's RHB-204 Granted FDA Fast Track Designation for NTM Disease redhillbio.com ↗
RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or “the Company”), a specialty biopharmaceutical company, today announced that RHB-204 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for its development as a potential first-line, stand-alone, oral treatment of pulmonary nontuberculous mycobacteria (NTM) disease caused by Mycobacterium avium Complex (MAC) – a rare disease for which there is no FDA-approved first-line therapy. |
| 2019-10-11 | RedHill Biopharma Limited | Results RedHill Biopharma Announces Full Results from Positive MAP US Phase 3 Study and Supportive Top-Line Results from MAP US2 Open-Label Extension Study with RHB-104 in Crohn’s Disease redhillbio.com ↗
The full Week 52 results of blinded treatment in the MAP US Phase 3 study with RHB-104 were consistent with the previously reported positive outcomes of the study. |
| 2019-10-11 | RedHill Biopharma Limited | Results RedHill Announces Full Results from MAP US Phase 3 Study and Supportive Top-Line Results from MAP US2 Study with RHB-104 in Crohn’s Disease redhillbio.com ↗
The full Week 52 results of blinded treatment in the MAP US Phase 3 study with RHB-104 were consistent with the previously reported positive outcomes of the study. |
| 2016-06-22 | RedHill Biopharma Limited | Results RedHill Biopharma Announces Publication Demonstrating Potential Efficacy of RHB-104 for Crohn's Disease Associated with MAP Infection redhillbio.com ↗
The results of the study demonstrated that the RHB-104 active components, in their individual concentrations or in dual combinations, were not as effective against all microorganisms, compared to the triple combination at minimum inhibitory concentrations level. |
| 2015-01-29 | Global Alliance for TB Drug Development | Results Phase 2a Published Results Show the Potential of a New TB Regimen with Novel Drugs Bedaquiline and Pretomanid (PA-824) tballiance.org ↗
However, it had no activity alone or in combinations with other drugs over the course of the two-week study. |
All press releases naming this drug 14 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 53 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Clofazimine | “Other drugs are used less commonly, such as amoxicillin-clavulanate, linezolid and clofazimine based on Investigator's decision twice a week from Day 1 up to 78 weeks after...” NCT02365623 ↗50“Experimental arms are seven oral regimens with a five-drug combination of the following: bedaquiline, linezolid, a fluoroquinolone (moxifloxacin or levofloxacin), cycloserine,...” NCT05081401 ↗ “The candidated drugs to be selected are:Cs-Cycloserine,Pto-Protionamide,Clr-Clarithromycin,PAS-sodium para-aminosalicylate,E-ethambutol,Bdq-Bedaquiline,Cfz-Clofazimine,Lzd-linezolid” NCT03830671 ↗ “Clofazimine (CLF) is an iminophenazine dye . It has a mild bactericidal action, acting slowly on M. leprae and destroying 99% of the bacteria in approximately five months.” NCT06819449 ↗ “PRS regimen, which consists of Clofazimine (Cfz), Ethambutol (E), high dose Pyrazinamide (Z, high), and Prothionamide (Pto).” NCT03561753 ↗ “For example, clofazimine has shown good efficacy in the treatment of nontuberculous mycobacterial lung disease.” NCT05494957 ↗ “to anti-MAP RHB-104 (clarithromycin 95 mg, rifabutin 45 mg, and clofazimine 10 mg per capsule) (n = 166)” PMID 39199994 ↗ Jul 2024 “Each capsule contains clarithromycin 158.3mg; rifabutin 40mg; clofazimine 13.3mg.” NCT04616924 ↗ “such as linezolid, clofazimine or ethambutol based on the DST results” NCT03604848 ↗ “PRS Regimen V(bedaquiline, delamanid, clofazimine, pyrazinamide)” NCT05278988 ↗ “95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine” NCT01717664 ↗ |
| Known as | CFZ | “The FQs - resistant group was treated with the BDLC regimen (BDQ, DLM, LZD, and clofazimine (CFZ))” NCT07126639 ↗1“Clofazimine (CFZ: Lamprene®), an established drug” PMID 30139372 ↗ Aug 2018 |
| Known as | Cfz-Clofazimine | “The candidated drugs to be selected are:Cs-Cycloserine,Pto-Protionamide,Clr-Clarithromycin,PAS-sodium para-aminosalicylate,E-ethambutol,Bdq-Bedaquiline,Cfz-Clofazimine,Lzd-linezolid” NCT03830671 ↗ |
| Known as | Chlofazimine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1292 ↗ |
| Known as | CLF | “Clofazimine (CLF) is an iminophenazine dye . It has a mild bactericidal action, acting slowly on M. leprae and destroying 99% of the bacteria in approximately five months.” NCT06819449 ↗ |
| Known as | Clofazimina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1292 ↗ |
| Known as | Clofaziminum | ChEMBL registry synonym — accepted as the source's own label CHEMBL1292 ↗ |
| Known as | Colfazimine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1292 ↗ |
| Known as | G 30320 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1292 ↗ |
| Known as | Lamprene | “Lamprene®/Clofazimine, is a product of the pharmaceutical company named Novartis Pharmaceuticals Corporation.” NCT04334070 ↗ |
| Known as | NSC-141046 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1292 ↗ |
| Modality | Small molecule | “lipophilic riminophenazine” NCT04081077 ↗ |
| Route | Oral | “ciprofloxacin, clofazimine, ethambutol, and rifampin (all taken orally)” NCT00000641 ↗ |