Clofazimine
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 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 11 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT07228702 Background | Jan 2026 → Oct 2027 expected | pulmonary non-tuberculous mycobacterial infection | Vancouver Coastal Health | Enrolling by invitation | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT07170800 Background | Sep 2025 → Feb 2026 overdue | multidrug-resistant tuberculosis, rifampicin-resistant tuberculosis | WestVac Biopharma Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT05007821 Background | Sep 2022 → Mar 2025 | multidrug-resistant tuberculosis, pulmonary tuberculosis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT02365623 Background | Feb 2015 → Nov 2018 | multidrug-resistant tuberculosis | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT06081361 Background | Dec 2023 → Oct 2026 expected | pulmonary tuberculosis, rifampicin-resistant tuberculosis | Beijing Chest Hospital | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04062201 Comparator | Aug 2019 → Apr 2024 | extensively drug-resistant tuberculosis, multidrug-resistant tuberculosis, rifampicin-resistant tuberculosis | Wits Health Consortium (Pty) Ltd | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT05494957 Background | Aug 2022 → Aug 2024 | pulmonary non-tuberculous mycobacterial infection | Shanghai Pulmonary Hospital, Shanghai, China | Unknown | No outcome recorded |
| Phase 4 | NCT05306223 Background | May 2022 → Aug 2025 | multidrug-resistant tuberculosis | Beijing Chest Hospital | Unknown | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT07198685 Comparator | Sep 2025 → Sep 2027 expected | — | Wuhan Pulmonary Hospital | Not yet recruiting | No outcome recorded |
| — | NCT07126639 Comparator | Sep 2025 → Sep 2027 expected | — | Wuhan Pulmonary Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06819449 Comparator | Dec 2024 → Dec 2025 overdue | leprosy | South Valley University | Recruiting | No outcome recorded |
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 ↗ “sutezolid, clofazimine, bedaquiline, delaminid” NCT03237182 ↗ “Clofazimine (C): 100 mg qd.” NCT07170800 ↗ “Clofazimine 100 mg daily” NCT03867136 ↗ |
| 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 ↗ |