A Phase 2, Randomised, Controlled, Multicentre Two-Part Trial Assessing the Safety and Efficacy of TBAJ-587 as Part of a Combination Regimen in Newly Diagnosed, Drug-Sensitive, Sputum-Positive Pulmonary Tuberculosis

A phase 2, two-part, multicentre, open label, controlled, randomised clinical trial in adult participants with newly diagnosed, sputum-positive pulmonary drug-sensitive tuberculosis (DSTB). Assessing the Safety and Efficacy of TBAJ-587 as Part of a Combination Regimen in Newly Diagnosed, Drug-Sensitive, Sputum-Positive Pulmonary Tuberculosis

Start Date25 Sep 2026

Sponsor / Collaborator

TASK Applied Science

ChiCTR2600123410

/ SuspendedPhase 1IIT

A Phase 1, Open-label, Parallel-arm Trial to Assess the Pharmacokinetics, Safety and Tolerability of Quabodepistat in Chinese Healthy Adults

Start Date09 Apr 2026

Sponsor / Collaborator

Shanghai Xuhui District Center Hospital

[+1]

CTIS2025-521502-18-00

/ CompletedPhase 1

A Trial to Determine if Quabodepistat is Processed Differently in Adults with Reduced Liver Function Compared to Adults with Normal Liver Function

Start Date13 Nov 2025

Sponsor / Collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

100 Clinical Results associated with Quabodepistat

100 Translational Medicine associated with Quabodepistat

100 Patents (Medical) associated with Quabodepistat

Literatures (Medical) associated with Quabodepistat

07 Oct 2026·ANTIMICROBIAL AGENTS AND CHEMOTHERAPY

Efficacy of quabodepistat alone and in combination with delamanid and bedaquiline against Mycobacterium tuberculosis in an NHP model evaluated by [ ¹⁸ F] FDG PET/CT and bacterial burden

Article

Author: Greenstein, T. ; Piazza, M. K. ; Repoli, K. M. ; Abdi, A. ; Egbelowo, O. ; Gomez, F. ; Via, L. E. ; Sloan, B. Y. ; Vatthauer, A. ; Kaya, F. ; Fleegle, J. D. ; Liu, Y. ; Aldridge, B. B. ; Weiner, D. M. ; Boshoff, H. I. M. ; Woodcock, M. J. ; Dartois, V. ; Gausi, K. ; Barry, C. E. ; Zimmerman, M. ; Sarathy, J. ; Chadalavada, D. ; Walker, A. M.

ABSTRACT:

Multidrug-resistant tuberculosis (MDR-TB) is challenging. Bedaquiline (B), delamanid (D), and pretomanid (P) are used in combination regimens with other anti-TB drugs for MDR-TB; however, agents with novel mechanisms of action are needed. DprE1 inhibitor quabodepistat (Q) was developed for combination use. In this study, Q alone or in combination with human-equivalent doses of D and/or B was evaluated in a marmoset TB model using in vivo imaging, with terminal bacterial counts from all lung lesions. Marmosets were infected with H37Rv Mycobacterium tuberculosis and allowed to develop the disease for 7 weeks. They were then administered a pre-treatment 18 F-fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG PET/CT) scan and randomized into seven treatment groups ( n = 5/group). At 2 weeks, the quabodepistat-treated groups showed a significant reduction in lesion volume compared to those without the agent in a post hoc analysis. After 2 months, the animals were euthanized, and the bacterial burden and histology were assessed. Marmosets treated with all agents showed reduced lung disease on PET/CT (>70%) compared to their pre-treatment disease volume. B reduced extrapulmonary bacteria more significantly than Q or D. Cavities and necrotic lesions from DBQ-treated animals had lower bacterial burdens than lesions treated with any of the single-agent or two-agent combinations. In a preliminary comparison, DBQ showed no statistically detectable difference from the standard-of-care regimen isoniazid-rifampicin-pyrazinamide-ethambutol (HRZE). Additionally, the activities of D and P monotherapies were similar in this model. The evaluation of these agents in the marmoset TB model supports further investigation of Q as a component of shorter TB regimens.

01 Oct 2026·LANCET INFECTIOUS DISEASES

Efficacy and safety of a 4-month quabodepistat, delamanid, and bedaquiline regimen for drug-susceptible pulmonary tuberculosis: a multicentre, open-label, randomised, proof-of-concept, non-inferiority, phase 2b/c trial

Article

Author: Takuva, Simbarashe ; Hafkin, Jeffrey ; Moloantoa, Tumelo ; Zuma-Gwala, Ntokozo ; Brumskine, William ; Xu, Raymond ; Bennet, Jaclyn Ann ; Diacon, Andreas H ; Dawson, Rodney ; Ngwanto, Tlhago ; Variava, Ebrahim ; Osman, Ayman ; Liu, Yongge ; Rassool, Mohammed ; Li, Wei

BACKGROUND:

Combined therapy with delamanid, bedaquiline, and quabodepistat (DBQ) showed potent early bactericidal activity and was well tolerated in a phase 2a, 14-day early bactericidal activity trial in participants with drug-susceptible pulmonary tuberculosis. This subsequent proof-of-concept trial evaluated the efficacy and safety of a 4-month, three-dose level regimen of DBQ in participants with drug-susceptible pulmonary tuberculosis compared with 6 months of the standard of care.

METHODS:

This open-label, randomised, proof-of-concept, non-inferiority, phase 2b/c trial was conducted at six clinical research sites in South Africa. Adults aged 18-65 years with newly diagnosed, drug-susceptible pulmonary tuberculosis were recruited by research sites from community tuberculosis clinics. Participants were randomly assigned (1:2:2:1) by balanced block randomisation (block size six) to receive oral delamanid (300 mg once a day) and bedaquiline (400 mg once a day for 2 weeks then 200 mg three times a week) plus quabodepistat at once-daily doses of 10 mg (DBQ10 group), 30 mg (DBQ30 group), or 90 mg (DBQ90 group) for 4 months; or 6 months of RHEZ (rifampicin, isoniazid, ethambutol, and pyrazinamide for 8 weeks followed by 18 weeks of rifampin and isoniazid). All drugs were administered orally. Masking procedures were not used, although microbiology laboratory staff were masked to treatment assignment. The primary endpoints were the proportion of participants reaching sputum culture conversion by the end of the treatment period in the modified intention-to-treat (mITT) analysis set and safety in the safety analysis set. Non-inferiority, with a margin of 12%, was assessed for the primary endpoint in the mITT analysis set, comparing the pooled DBQ group and the RHEZ group using a two-sided 80% CI. This study was registered at ClinicalTrials.gov, NCT05221502, and is complete.

FINDINGS:

Between April 12, 2022, and May 19, 2024, 306 individuals were screened, of whom 122 were enrolled and randomly assigned: 20 to the DBQ10 group, 42 to the DBQ30 group, 39 to the DBQ90 group, and 21 to the RHEZ group. 121 participants received at least one dose of study drug and comprised the mITT analysis set. At the end of the treatment period, the proportion of participants with sputum culture conversion was 100·0% (95% CI 83·2-100·0, all 20 participants) in the DBQ10 group, 92·9% (80·5-98·5, 39 of 42 participants) in the DBQ30 group, 97·4% (86·2-99·9, 37 of 38 participants) in the DBQ90 group, 96·0% (90·1-98·9, 96 of 100 participants) in the pooled DBQ group, and 100·0% (83·9-100·0, all 21 participants) in the RHEZ group. The comparison between the pooled DBQ group and the RHEZ group met non-inferiority for the primary endpoint (difference -4·0% [80% CI -7·4 to 3·4]). Adverse events were mostly mild to moderate, with no serious adverse events or discontinuations attributed to trial medications. Rates of adverse events of grade 3 or higher were 20% (four of 20 participants) in the DBQ10 group, 14% (six of 42 participants) in the DBQ30 group, 11% (four of 38 participants) in the DBQ90 group, and 5% (one of 21 participants) in the RHEZ group. One participant (in the DBQ90 group) died after worsening pulmonary tuberculosis with pneumonia, which was assessed as not related to study treatment. 105 (87%) of 121 participants had at least one treatment-emergent adverse event: 17 (85%) of 20 in the DBQ10 group, 37 (88%) of 42 in the DBQ30 group, 30 (79%) of 38 in the DBQ90 group, and all 21 (100%) participants in the RHEZ group. The most common treatment-emergent adverse events in the total population of 121 participants were upper respiratory tract infection (n=36, 30%), headache (n=24, 20%), and diarrhoea (n=12, 10%).

INTERPRETATION:

In this proof-of-concept study, 4 months of DBQ showed a promising end-of-treatment non-inferiority signal versus 6 months of RHEZ and was generally well tolerated. Our results support further studies of quabodepistat as a potential component of new treatment-shortening regimens for tuberculosis.

FUNDING:

Otsuka Pharmaceutical Development & Commercialization, with partial funding from the Gates Foundation.

12 Apr 2026·Zhonghua jie he he hu xi za zhi = Zhonghua jiehe he huxi zazhi = Chinese journal of tuberculosis and respiratory diseases

[Annual progress in chemotherapy for tuberculosis in 2025].

Review

Author: Li, H Y ; Tang, S J ; Wang, M S ; Xiong, Y

In recent years, substantial progress in the development of anti-tuberculosis (TB) drugs and treatment strategies has accelerated the transition of TB chemotherapy toward shorter-course, all-oral, and increasingly individualized regimens. Over the past year, short-course rifamycin-containing preventive therapies (1HP, 3HP, and 4R) have consistently demonstrated high adherence and favorable safety across diverse populations. In addition, fluoroquinolone-based regimens for contacts of multidrug-resistant TB have gained strong evidence-based support. In the therapeutic domain, multiple phase Ⅱ and Ⅲ trials have further validated the clinical value of novel mechanisms and optimized combinations. New agents such as Telacebec, Quabodepistat, Sutezolid, and Delpazolid exhibit potent bactericidal activity and lower toxicity, laying the foundation for regimen shortening and combination optimization. The BPaL/BPaLM regimens have achieved high cure rates, rapid culture conversion, and good tolerability in real-world studies across several countries. In addition, 9-month (Bedaquiline-Linezolid-Fluoroquinolone-based) and 6-9-month all-oral regimens with varied combinations have shown comparable efficacy across different resistance patterns and resource settings, providing feasible alternatives in regions where Pretomanid availability is limited. For drug-susceptible pulmonary TB, the 4-month rifapentine-moxifloxacin regimen (2HPZM/2HPM) has been endorsed in recent clinical guidelines. Collectively, these developments indicate that TB chemotherapy is shifting from conventional uniform treatment courses toward precision-stratified and individualized management. Future progress is expected to focus on four key directions: discovery of new mechanisms and innovative regimen combinations; precision pharmacological management guided by pharmacokinetic/pharmacodynamic principles and therapeutic drug monitoring; safety assessment and stratified strategies for special populations; and the generation of robust real-world evidence to support globally harmonized yet locally adapted implementation. This review systematically summarizes advances in TB chemotherapy research from October 2024 to September 2025, with emphasis on preventive therapy, treatment of drug-susceptible and rifampicin-resistant TB, and the translation of emerging evidence into clinical practice to inform China's TB control strategies.

News (Medical) associated with Quabodepistat

06 Nov 2025

·www.otsuka.co.jp

Otsuka Announces First Participants Enrolled in Phase 3 Clinical Trial Evaluating Investigational Compound Quabodepistat for Drug-resistant Pulmonary Tuberculosis

Otsuka Pharmaceutical Co. Ltd., (Otsuka) and its U.S. subsidiary, Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) today announced that the first participants have been successfully enrolled and dosed in its Phase 3 clinical trial evaluating quabodepistat, an investigational compound for the treatment of pulmonary multidrug-resistant tuberculosis (MDR-TB). TB, and particularly its resistant forms, remains a major global health challenge. According to the World Health Organization, over 10 million people fall ill with tuberculosis each year, most of whom live in low- to middle-income countries. Despite being preventable and curable, 1.25 million people die from the disease annually1. The Phase 3 trial named QUANTUM-TB (Quabodepistat Accelerating New Treatments for Multidrug- Resistant Tuberculosis), is a randomized study designed to evaluate efficacy, safety, and tolerability of quabodepistat-containing regimens in adults and adolescents aged 14 and above. The primary goal of the quabodepistat clinical development program is to develop an efficacious, shorter-duration, less toxic, and well-tolerated regimen for treatment of people suffering from MDR-TB. The trial will compare a quabodepistat-based regimen administered for 17 weeks in participants with fluoroquinolone-sensitive MDR-TB and for 26 weeks in participants with fluoroquinolone-resistant MDR-TB against the corresponding WHO standards of care. The first participants were enrolled in the Philippines, marking a significant milestone in the development of this investigational compound. The trial is scheduled to be conducted at over 30 sites in several countries across the globe, including Japan. "We are excited to begin this important trial and are deeply grateful to the participants and investigators," said Masanori Kawasaki, senior vice president & operating officer, associate general manager (Research) at Otsuka. "This trial represents a critical step toward addressing the unmet needs of individuals suffering from drug-resistant TB." This Phase 3 clinical trial is registered on ClinicalTrials.gov under the identifier NCT07209761. More information is available at: https://clinicaltrials.gov/study/NCT07209761 1Global tuberculosis report 2024. Geneva: World Health Organization; 2024. Licence: CC BY-NC-SA 3.0 IGO. About Otsuka Otsuka Pharmaceutical Co., Ltd. is a total healthcare company that focuses on each individual's potential to enhance their well-being. Our medical-related business provides treatments and diagnostics for both physical and mental health. Our nutraceutical business supports daily health maintenance and improvement. Otsuka's unique products and services are based on scientific evidence, under the guidance of our corporate philosophy: Otsuka-people creating new products for better health worldwide.

Phase 3

05 Nov 2025

·www.drugs.com

Otsuka Announces First Participants Enrolled in Phase 3 Clinical Trial Evaluating Investigational Compound Quabodepistat for Drug-resistant Pulmonary Tuberculosis

PRINCETON, N.J. and TOKYO, JAPAN — November 5, 2025 – Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and our parent company Otsuka Pharmaceutical Co. Ltd., (Otsuka) today announced that the first patients have been successfully enrolled and dosed in its Phase 3 clinical trial evaluating quabodepistat, an investigational compound for the treatment of pulmonary multidrug-resistant tuberculosis (MDR-TB). TB, and particularly its resistant forms, remains a major global health challenge. According to the World Health Organization, 10 million people fall ill with tuberculosis each year, most of whom live in low- to middle-income countries. Despite being preventable and curable, 1.25 million people die from the disease annually. The Phase 3 trial named QUANTUM-TB ( Qu abodepistat A ccelerating N ew T reatments for M ultidrug- Resistant Tuberculosis ), is a randomized study designed to evaluate efficacy, safety, and tolerability of quabodepistat-containing regimens in adults and adolescents aged 14 and above. The primary goal of the quabodepistat clinical development program is to develop an efficacious, shorter-duration, less toxic, and well-tolerated regimen for treatment of people suffering from MDR-TB. The trial will compare a quabodepistat-based regimen administered for 17 weeks in participants with fluoroquinolone-sensitive MDR-TB and for 26 weeks in participants with fluoroquinolone-resistant MDR-TB against the corresponding WHO standards of care. The first participants were enrolled in the Philippines, marking a significant milestone in the development of this investigational compound. The trial is scheduled to be conducted at over 30 sites in several countries across the globe, including Japan. “We are excited to begin this important trial and are deeply grateful to the participants and investigators,” said Masanori Kawasaki, senior vice president & operating officer, associate general manager (Research) at Otsuka. “This trial represents a critical step toward addressing the unmet needs of individuals suffering from drug-resistant TB.” This Phase 3 clinical trial is registered on ClinicalTrials.gov under the identifier NCT07209761 . More information about the trial can be found at https://clinicaltrials.gov/study/NCT07209761 . About Otsuka Otsuka Pharmaceutical Co., Ltd. is a total healthcare company that focuses on each individual’s potential to enhance their well-being. Our medical-related business provides treatments and diagnostics for both physical and mental health. Our nutraceutical business supports daily health maintenance and improvement. Otsuka’s unique products and services are based on scientific evidence, under the guidance of our corporate philosophy: Otsuka-people creating new products for better health worldwide . Otsuka established a presence in the U.S. in 1973 and today our U.S. affiliates include Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka America Pharmaceutical, Inc. (OAPI). These two companies’ 2,250 employees develop and commercialize medicines in the areas of mental health and nephrology, using cutting-edge technology to address unmet healthcare needs. OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Co., Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 35,340 people worldwide and had consolidated sales of approximately USD 14.7 billion in 2024. All Otsuka stories start by taking the road less traveled. Learn more about Otsuka in the U.S. at www.otsuka-us.com and connect with us on LinkedIn and Twitter at @OtsukaUS . Otsuka Pharmaceutical Co., Ltd.’s global website is accessible at https://www.otsuka.co.jp/en/. Source: Otsuka Pharmaceutical Co., Ltd.

Phase 3

22 Mar 2024

·www.otsuka.co.jp

Otsuka Announces Interim Data from Phase 2b/c Trial Indicating New Investigational Compound May Shorten Tuberculosis Treatment

Otsuka Pharmaceutical, Co. Ltd. And our U.S.-based subsidiary Otsuka Pharmaceutical Development & Commercialization, Inc., announce that interim data from a Phase 2b/c trial exploring quabodepistat (QBS), in combination with delamanid and bedaquiline, for the treatment of pulmonary tuberculosis (TB) is positive and may shorten the duration of TB treatment for patients. QBS is an investigational anti-tuberculosis compound which has a new mechanism of action that interferes with the cell-wall structure of the bacteria causing TB.1,2 Worldwide, TB is the second leading infectious fatal disease after COVID-19. The interim analysis -- which was presented at the 2024 Conference on Retroviruses and Opportunistic Infections in Denver, Colorado in early March -- demonstrated that a four-month regimen of QBS, in combination with delamanid and bedaquiline, can achieve similar safety and efficacy, compared to the six-month, standard-of-care four-drug regimen in participants with drug-susceptible TB.3 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. The three-drug QBS-based arms were well-tolerated, with no serious treatment emergent adverse events reported, related to the regimens.3 The ongoing study, supported by Otsuka and the Bill & Melinda Gates Foundation, is being held across six clinical research sites in South Africa. Otsuka and the foundation have been collaborating to end TB worldwide, and the foundation contributed to initial funding for the early development of quabodepistat.2,3 "Otsuka is encouraged by these positive interim data and is pleased to continue working with the support of the Bill & Melinda Gates Foundation to identify safe and effective treatment options for patients living with tuberculosis," said Masanori Kawasaki, global project leader of TB Project at Otsuka Pharmaceutical. "We are deeply thankful to the patients, their families and the clinicians who participated in this important clinical research study." The trial (NCT05221502) was a multicenter, Phase 2b/c, open-label, randomized, dose-finding trial designed to evaluate the safety and efficacy of a four-month regimen of OPC-167832 (quabodepistat) in combination with delamanid and bedaquiline in patients with drug-susceptible pulmonary tuberculosis in comparison with six months standard treatment. Full results of this phase 2b/c, randomized trial are expected by the end of 2024.2,3 *1Hariguchi N et al. OPC-167832, a Novel Carbostyril Derivative with Potent Antituberculosis Activity as a DprE1 Inhibitor. Antimicrob Agents Chemother. 2020 May 21;64(6):e02020-19. *2Dawson R et al. Quabodepistat in Combination with Delamanid and Bedaquiline in Participants with Drug-Susceptible Pulmonary Tuberculosis: protocol for a multicenter, phase 2 b/c, open-label, randomized, dose-finding trial to evaluate safety and efficacy. Trials. 2024 Jan 19;25(1):70. *3Dawson R et al. A 4-month Regimen of Quabodepistat, Delamanid and Bedaquiline for Pulmonary TB: Interim Results. Conference on Retroviruses and Opportunistic Infections (CROI), 5 March 2024, Denver, Co., USA; Abstract no. 163. *4World Health Organization, Tuberculosis key facts　https://www.who.int/news-room/fact-sheets/detail/tuberculosis

Phase 2Clinical ResultPhase 3

100 Deals associated with Quabodepistat

External Link

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Multidrug resistant pulmonary tuberculosis	Phase 3	United States	Otsuka Pharmaceutical Development & Commercialization, Inc.	16 Oct 2025
Pulmonary Tuberculosis	Phase 2	Philippines	Janssen Pharmaceutica NV	26 Jul 2023
Pulmonary Tuberculosis	Phase 2	South Africa	Janssen Pharmaceutica NV	26 Jul 2023
Tuberculosis	Phase 1	Bulgaria	Otsuka Pharmaceutical Development & Commercialization, Inc.	13 Nov 2025
Tuberculosis, Multidrug-Resistant	IND Approval	China	Otsuka Pharmaceutical Co., Ltd.	01 Sep 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05221502 (Pubmed \| Lancet Infect Dis)	Phase 2/3	Pulmonary Tuberculosis	121	Delamanid+bedaquiline+quabodepistat 10 mg	csfvoalkxb(ksympfzxft) = ebjgdmvhvf altmouzcrm (uixproxeph, 83.2 - 100.0) View more	Positive	01 Oct 2026
				Delamanid+bedaquiline+quabodepistat 30 mg	lannpvpgjr(mszhrptykn) = fwrxqsyvyi sybhyqgnih (etzpeqqnjp ) View more
NCT05221502 (CTgov)	Phase 2	Pulmonary Tuberculosis	122	OPC-167832+Bedaquiline+Delamanid (Delamanid + Bedaquiline + OPC-167832 10 mg)	qwragymswu = cnolwwezda lewxcxooxh (knftjakjgz, gxlkioffxf - fiozdjsnfe) View more	-	12 Aug 2026
				OPC-167832+Bedaquiline+Delamanid (Delamanid + Bedaquiline + OPC-167832 30 mg)	qwragymswu = jmummtelpe lewxcxooxh (knftjakjgz, umrxkkfsdj - aadnfsbjju) View more
NCT07542847 (CTgov)	Phase 1	-	24	itraconazole+OPC-167832 (Part 1: OPC-167832 and Itraconazole)	jnhhajibpy = hetwnkmgod ujhqvchfte (fhrgizsvcx, mbkwlmsrpk - vxsqbhssgp) View more	-	05 Jun 2026
				OPC-167832+Carbamazepine (Part 2: OPC-167832 and Carbamazepine)	jnhhajibpy = yumxyrpkgh ujhqvchfte (fhrgizsvcx, pncromnmug - uchrizxtsp) View more
NCT05971602 (CTgov)	Phase 2	Pulmonary Tuberculosis	93	OPC-167832+Bedaquiline+Delamanid+Sutezolid (DBOS) (Arm 1: Delamanid + Bedaquiline + OPC-167832 + Sutezolid (DBOS))	oxgftlknao = zwzoyjxnzs hfxdlxltax (tebbvbsjrh, eflkkushot - jnxmlsmepw) View more	-	20 May 2026
				Pretomanid+OPC-167832+Bedaquiline+Sutezolid (PBOS) (Arm 2: Pretomanid + Bedaquiline + OPC-167832 + Sutezolid (PBOS))	oxgftlknao = fwvlzennuk hfxdlxltax (tebbvbsjrh, qiayynvlpu - miwwdkxiks) View more
NCT03678688 (CTgov)	Phase 1/2	Pulmonary Tuberculosis	122	10 mg OPC-167832 (Stage 1: 10 mg OPC-167832)	wxiufhkckt(mpnihjhjqv) = sfmcjyhuwc gcjgoforue (wljeugrwsy, 0.98) View more	-	18 Nov 2023
				30 mg OPC-167832 (Stage 1: 30 mg OPC-167832)	wxiufhkckt(mpnihjhjqv) = hmmhpiuynk gcjgoforue (wljeugrwsy, 1.01) View more

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