Bedaquiline
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed multidrug-resistant tuberculosis 2 milestones | |||||
| Filed | EU (EMA) | SIRTURO | multidrug-resistant tuberculosis | 2023-11-07 | “announced today the submission of a Type II Variation application to the European Medicines Agency (EMA) for the Company’s medicine SIRTURO®(bedaquiline).” jnj.com ↗ |
| Filed | EU (EMA) | — | multidrug-resistant tuberculosis | 2019-08-09 | “Janssen has also filed for approval of the use of bedaquiline in adolescents with the European Medicines Agency (EMA)” jnj.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| 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
News releases announcing trial results or a regulatory action · 20
| Date | Issuer | Release |
|---|---|---|
| 2025-12-16 | MicuRx | Results “世界肺部健康大会”传佳音 含康替唑胺的创新抗结核方案绽光彩 micurx.com ↗
INSPIRE-CODA研究团队纳入的212例患者的临床数据显示，含康替唑胺的创新短程方案不仅早期疗效非劣于传统长程方案，更在安全性上实现突破——神经系统与血液系统不良反应发生率较传统方案显著降低。 |
| 2025-11-19 | Global Alliance for TB Drug Development | Results Phase 2 Clinical Trial Results Show Potential to Shorten TB Treatment Time tballiance.org ↗
The NC-009 trial (a pan-Phase 2 clinical trial) showed that, overall, sorfequiline had greater activity than bedaquiline. |
| 2024-07-02 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson Receives Approval from U.S. FDA and European Commission for SIRTURO® (bedaquiline) jnj.com ↗
With the FDA’s approval, label restrictions that were included when the medicine was granted accelerated approval in the U.S. in December 2012 are removed. |
| 2024-04-29 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson Receives Positive CHMP Opinion Recommending Full Approval for SIRTURO® (bedaquiline) for Treatment of Multidrug-Resistant Tuberculosis jnj.com ↗
The positive CHMP recommendation is supported by data from the Phase 3 STREAM Stage 2 study (NCT02409290), the first large-scale, randomized, multi-country clinical study to evaluate the efficacy and safety of an all-oral bedaquiline-containing regimen for treatment of MDR-TB. |
| 2024-03-22 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results Otsuka Announces Interim Data from Phase 2b/c Trial Indicating New Investigational Compound May Shorten Tuberculosis Treatment otsuka.co.jp ↗
These results show that sputum culture conversion rates -- or effectiveness of the treatment combination in killing the bacteria -- at the end of treatment in the pooled QBS-based, three-drug regimen arms were on par with existing standard four-drug TB treatment. |
| 2024-03-21 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results Otsuka Announces Interim Data from Phase 2b/c Trial Indicating New Investigational Compound May Shorten Tuberculosis Treatment otsuka-us.com ↗
These results show that sputum culture conversion rates — or effectiveness of the treatment combination in killing the bacteria — at the end of treatment in the pooled QBS-based, three-drug regimen arms were on par with existing standard four-drug TB treatment. |
| 2023-11-07 | Janssen Research & Development, LLC | Regulatory Janssen Submits Phase 3 Study Data to the European Medicines Agency and U.S. Food and Drug Administration for SIRTURO® (bedaquiline) jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), announced today the submission of a Type II Variation application to the European Medicines Agency (EMA) for the Company’s medicine SIRTURO®(bedaquiline). |
| 2020-05-27 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves New Pediatric Formulation of SIRTURO® (bedaquiline) as Part of Combination Therapy to Treat Children with Pulmonary Multidrug-Resistant Tuberculosis jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has granted approval for a new pediatric formulation of SIRTURO®(bedaquiline). |
| 2020-05-27 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves New Pediatric Formulation of SIRTURO® (bedaquiline) as Part of Combination Therapy to Treat Children with Pulmonary Multidrug-Resistant Tuberculosis jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has granted approval for a new pediatric formulation of SIRTURO® (bedaquiline). |
| 2019-12-16 | Janssen Research & Development, LLC | Regulatory World Health Organization Recommends the Use of Bedaquiline-Containing Treatment Regimens For All Drug-Resistant Tuberculosis Patients jnj.com ↗
Johnson & Johnson recognizes the World Health Organization (WHO)’s Rapid Communication indicating that all-oral regimens containing Johnson & Johnson’s SIRTURO® (bedaquiline) are the preferred treatment options for all patients with multidrug-resistant tuberculosis (MDR-TB) and rifampicin-resistant TB (RR-TB). |
| 2019-11-13 | Global Alliance for TB Drug Development | Results Results of Phase 2B Clinical Trial Testing New Drug-Resistant TB Treatment Published in Lancet Respiratory Medicine tballiance.org ↗
Results of the Phase 2B trial, known as NC-005 have been published in The Lancet Respiratory Medicine. |
| 2019-08-09 | Janssen Research & Development, LLC | Regulatory Janssen Announces U.S. FDA Accelerated Approval for SIRTURO® (bedaquiline) as Part of Combination Therapy to Treat Adolescents with Pulmonary Multidrug-Resistant Tuberculosis jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has granted approval for SIRTURO®(bedaquiline) tablets as part of combination therapy in pediatric patients – those over the age of 12 and younger than 18 and weighing at least 66 pounds (30 kilograms) – with pulmonary multidrug-resistant tuberculosis (MDR-TB), when an effective treatment regimen cannot otherwise be provided. |
| 2019-06-06 | Global Alliance for TB Drug Development | Regulatory FDA Advisory Committee Votes Favorably on the Question of the Effectiveness and Safety of Pretomanid in Combination with Bedaquiline and Linezolid for Treatment of Highly Drug-Resistant Forms of Tuberculosis tballiance.org ↗ |
| 2016-12-16 | Global Alliance for TB Drug Development | Results Clinical Trial of BPaMZ Regimen Will Replace Phase 3 STAND Trial tballiance.org ↗
In light of these results, where the BPaMZ regimen appears to be much more promising compared to the PaMZ (pretomanid + moxifloxacin + pyrazinamide) regimen, the STAND trial testing the PaMZ regimen will not be reopened to new patients. |
| 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 ↗
Specifically, the BPaZ regimen killed more than 99 percent of TB bacteria in patient’s sputum in two weeks, and appeared well tolerated and safe. |
| 2014-03-06 | Janssen Research & Development, LLC | Regulatory SIRTURO® (bedaquiline) Receives Conditional Approval in the European Union for the Treatment of Multi-Drug Resistant Tuberculosis jnj.com ↗
Janssen-Cilag International NV (Janssen) announced today that the European Commission (EC) has granted conditional approval to SIRTURO ® (bedaquiline) in the European Union, for use as part of an appropriate combination regimen for pulmonary multi -drug resistant tuberculosis (MDR -TB) in adult patients, when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. |
| 2013-12-20 | Janssen Research & Development, LLC | Regulatory SIRTURO® (bedaquiline) Receives Positive Opinion from the Committee for MedicinalProducts for Human Use as Part of Combination Therapy to Treat Adults with PulmonaryMulti-Drug Resistant Tuberculosis jnj.com ↗
The CHMP positive opinion is an important step in the conditional approval of bedaquiline, and will now be considered by the European Commission (EC), which has the authority to approve medicines for use throughout the European Union. |
| 2013-12-19 | Pharmstandard | Regulatory Pharmstandard announces registration of Sirturo® for MDR-TB pharmstd.com ↗
Moscow, December 19, 2013 — Russia’s leading pharmaceutical company Pharmstandard OJSC («Pharmstandard» or the «Company») announces registration of the drug Sirturo®(«Sirturo» or the «Drug») in Russia. |
| 2010-07-26 | Sequella, Inc. | Results Two New Tuberculosis (TB) Drugs Show Significant Synergy In Vitro sequella.com ↗
The results of the studies, a research collaboration between Sequella and Tibotec, demonstrated that the combination of SQ109 with TMC207 decreased the TMC207 minimal inhibitory concentration (MIC) by 4- to 8-fold for the etiologic agent of TB, Mycobacterium tuberculosis. |
| 2008-10-28 | Sequella, Inc. | Results Sequella Presents Data on Synergy Between Investigational New TB Drugs SQ109 and TMC207 sequella.com ↗
SQ109 and TMC207 in combination were either synergistic or additive with the various MTB strains and showed increased rate of killing, enhanced post antibiotic effect and intracellular killing activity. |
All press releases naming this drug 27 releases
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 | “This two-stage study will compare consented research participants with tuberculous meningitis receiving experimental Bedaquiline (B), Pretomanid (Pa), Linezolid (L);...” NCT07227779 ↗73“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 “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 ↗ “PRS Regimen V(bedaquiline, delamanid, clofazimine, pyrazinamide)” NCT05278988 ↗ “clofazimine, bedaquiline, delaminid, para-aminosalicylic acid” NCT03237182 ↗ |
| 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 20229“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 “Bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z), plus rifabutin (Rb), followed by” NCT05766267 ↗ “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 ↗ |