Bedaquiline
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (4) | US (FDA) | SIRTURO | — | 2019-08-09 – 2025-07-28 | fda.gov ↗ |
| Approved | EU (EMA) | Sirturo | — | 2014-03-05 | europa.eu ↗ |
| Approved | US (FDA) | SIRTURO | — | 2012-12-28 | fda.gov ↗ |
Trials 76 · started per year
Also used as a comparator or background therapy in 15 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 29 trials | ||||||
| Phase 2 | NCT07517445 Comparator | Apr 2026 → Jun 2027 expected | primary pulmonary tuberculosis | Gates Medical Research Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT07525427 Background | Apr → Nov 2026 expected | pulmonary tuberculosis | Gates Medical Research Institute | Recruiting | No outcome recorded |
| 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 | NCT06058299 Comparator | Oct 2023 → Dec 2024 overdue | pulmonary tuberculosis | Global Alliance for TB Drug Development | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05926466 Background | Sep 2023 → Aug 2024 | pulmonary tuberculosis | Michael Hoelscher | Unknown | No outcome recorded |
| Phase 2 | NCT04550832 Background | Oct 2021 → Jan 2023 | pulmonary tuberculosis | LigaChem Biosciences, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04179500 Background | Sep 2021 → Jun 2023 | multidrug-resistant tuberculosis, pulmonary tuberculosis | Global Alliance for TB Drug Development | Completed | No outcome recorded |
| Phase 2 | NCT03959566 Background | May 2021 → Sep 2022 | pulmonary tuberculosis | Michael Hoelscher | Completed | No outcome recorded |
| Phase 2 | NCT04608955 Comparator | Oct 2020 → Apr 2022 | pulmonary tuberculosis | Shanghai Jiatan Pharmatech Co., Ltd | Completed | No outcome recorded |
| Phase 33 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 | NCT05824871 Comparator | Sep 2022 → Dec 2025 overdue | multidrug-resistant tuberculosis, rifampicin-resistant tuberculosis | Shanghai Jiatan Pharmatech Co., Ltd | Recruiting | No outcome recorded |
| Phase 3 | NCT05040126 Background | Oct 2021 → Dec 2024 | multidrug-resistant tuberculosis | Tuberculosis Research Centre, India | Unknown | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT05494957 Background | Aug 2022 → Aug 2024 | pulmonary non-tuberculous mycobacterial infection | Shanghai Pulmonary Hospital, Shanghai, China | Unknown | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07198685 Background | Sep 2025 → Sep 2027 expected | — | Wuhan Pulmonary Hospital | Not yet recruiting | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-08-10 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Awarded Grant for Phase 2 Trial Combining Novel Anti-Tuberculosis Compound OPC-167832 with Delamanid and Bedaquiline otsuka.co.jp ↗ |
| 2021-08-09 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Awarded Grant for Phase 2 Trial Combining Novel Anti-Tuberculosis Compound OPC-167832 with Delamanid and Bedaquiline otsuka-us.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 96 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | bedaquiline | “Bedaquiline (Sirturo, TMC207), a diarylquinoline that inhibits mycobacterial ATP synthase, has been associated with accelerated sputum-culture conversion in patients with...” PMID 25140958 ↗ Aug 201473“The objective of this study is to analyze the efficacy of a new regimen using Bedaquiline, Pretomanid, Linezolid, and Moxifloxacin for 24 weeks or Bedaquiline, Pretomanid,...” NCT05381194 ↗ “Experimental arms are seven oral regimens with a five-drug combination of the following: bedaquiline, linezolid, a fluoroquinolone (moxifloxacin or levofloxacin), cycloserine,...” NCT05081401 ↗ “Bedaquiline 400 mg once daily for 2 weeks then 100 mg once daily for 15 weeks + Pretomanid 200 mg QD for 17 weeks + Quabodepistat 30 mg once daily for 17 weeks + Moxifloxacin...” NCT07209761 ↗ “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 ↗ “Investigators have selected a number of new drugs, including bedaquiline, to form a regimen to conduct clinical studies for the treatment of severe NTM lung disease.” NCT05494957 ↗ “The investigational MDR-END Plus regimen consists of oral anti-tuberculosis drugs including bedaquiline, delamanid, delpazolid, levofloxacin, and pyrazinamide.” NCT07675954 ↗ “Bedaquiline (B): For the first 2 weeks, 400 mg qd; then adjust to 200 mg tiw.” NCT07170800 ↗ “bedaquiline, pretomanid, linezolid, moxifloxacin, and pyrazinamide” NCT07227779 ↗ “PRS Regimen V(bedaquiline, delamanid, clofazimine, pyrazinamide)” NCT05278988 ↗ “clofazimine, bedaquiline, delaminid, para-aminosalicylic acid” NCT03237182 ↗ “Stage 2: 30 mg OPC-167832 + 400 mg Bedaquiline (BDQ)” NCT03678688 ↗ “Drug:bedaquiline 100mg tablets” NCT06476210 ↗ “Bedaquiline (BDQ):” NCT07268664 ↗ |
| Known as | BDQ | “Our objective is to evaluate the effectiveness, safety and tolerability of various doses and duration of linezolid (LZD) in combination with bedaquiline (BDQ) and pretomanid...” PMID 36038181 ↗ Aug 20228“This study evaluated the safety, tolerability, and pharmacokinetics of the anti-tuberculosis (TB) drugs bedaquiline (BDQ) and delamanid (DLM), alone and in combination, among...” NCT02583048 ↗ “Participants received bedaquiline (BDQ) once per day through intensive PK sampling visit, then 3 times per week on Monday, Wednesday and Friday through the week 24 visit.” NCT02906007 ↗ “6-month all-oral regimen, consisting of Bedaquiline (BDQ, B), Delamanid (DLM, D), Linezolid (LZD, L), Levofloxacin (LFX) , as known as BDLL regimen” NCT07198685 ↗ “The purpose of the study is to evaluate the efficacy of bedaquiline (BDQ) compared with rifamycin when administered as part of a treatment regimen” NCT04630145 ↗ “A six - month regimen containing bedaquiline (BDQ), pretomanid (Pa), linezolid (LZD), and moxifloxacin (MFX)” NCT07126639 ↗ “Regimen A (bedaquiline [Bdq]+linezolid [Lzd]+moxifloxacin [Mfx]+cycloserine [Cs]+pyrazinamide [Pza])” PMID 37567554 ↗ Aug 2023 “Stage 2: 30 mg OPC-167832 + 400 mg Bedaquiline (BDQ)” NCT03678688 ↗ “Bedaquiline (BDQ):” NCT07268664 ↗ |
| Known as | Bdq-Bedaquiline | “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 | Bedaquilina | ChEMBL registry synonym — accepted as the source's own label CHEMBL376488 ↗ |
| Known as | BEDAQUILINE FUMARATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL376488 ↗ |
| Known as | R-207910 | ChEMBL registry synonym — accepted as the source's own label CHEMBL376488 ↗ |
| Known as | R-403323 | ChEMBL registry synonym — accepted as the source's own label CHEMBL376488 ↗ |
| Known as | Sirturo | “Bedaquiline (Sirturo, TMC207), a diarylquinoline that inhibits mycobacterial ATP synthase, has been associated with accelerated sputum-culture conversion in patients with...” PMID 25140958 ↗ Aug 2014 |
| Known as | TMC207 | “The purpose of this study is to determine the relative oral bioavailability (the extent to which a medication or other substance becomes available to the body as compared with...” NCT00946842 ↗18“One tablet equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.” NCT01803373 ↗ “Bedaquiline (TMC207) oral tablet adult formulation” NCT02354014 ↗ |
| Action | Inhibit | “that inhibits mycobacterial ATP synthase” PMID 30024924 ↗ Jul 2018 |
| Modality | Small molecule | “a diarylquinoline” PMID 30024924 ↗ Jul 2018 |
| Route | Oral | “Subjects will receive orally 25 mg TMC207 po q.d. (Treatment A), 100 mg TMC207 po q.d. (Treatment B) or 400 mg TMC207 po q.d. (Treatment C)” NCT00523926 ↗ |