Drug

Delamanid

Approved · EMA

Late-stage development

Also known as (2R)-2-methyl-6-nitro-2-((4-(4-(4-(trifluoromethoxy)phenoxy)piperidin-1-yl)phenoxy)methyl)-2,3-dihydroimidazo(2,1-B)(1,3)oxazole, Imidazo(2,1-B)oxazole, 2,3-dihydro-2-methyl-6-nitro-2-((4-(4-(4-(trifluoromethoxy)phenoxy)-1-piperidinyl)phenoxy)methyl)-, (2R)-.

RxNorm1344662 ChEMBLCHEMBL218650UNII8OOT6M1PC7

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Prospective, Randomized, Partially Blinded, Phase 2 Study of the Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine for Treatment of Patients With MDR-TB

Clinical trial2026-07-08Results expected Q2 2027 · ClinicalTrials.gov

A Phase I/II Open-Label, Single-Arm Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Delamanid in Combination With Optimized Multidrug Background Regimen (OBR) for Multidrug-Resistant Tuberculosis (MDR-TB) in Children With MDR-TB With and Without HIV

Clinical trial2026-06-25Results posted · ClinicalTrials.gov

A Parallel Group, Phase 2A, Randomised, Open Label Treatment Study to Assess the Early Bactericidal Activity, Safety and Tolerability of GSK3036656 Administered as a Two Drug Combination With Novel and Established Antitubercular Agents, or Standard of Care in Adults With Rifampicin-susceptible Pulmonary Tuberculosis

Clinical trial2026-06-17Results posted · ClinicalTrials.gov

A Phase II, Prospective, Randomized, Multicenter Trial to Evaluate the Efficacy and Safety/Tolerability of Two Linezolid Dosing Strategies in Combination With a Short Course Regimen for the Treatment of Drug-Resistant Pulmonary Tuberculosis

Clinical trial2026-05-01Results posted · ClinicalTrials.gov

A Multicenter, Open-label, Randomized, Active-controlled Clinical Study to Compare the Efficacy and Safety of Different Combination Regimens of JDB0131 Benzenesulfonate Tablets With Delamanid in Patients With Rifampin-resistant Tuberculosis (JD-RISE)

Clinical trial2026-02-28Primary completion · ClinicalTrials.gov

A Seamless Phase 2B/C Platform Trial to Evaluate Multiple Regimens and Durations of Treatment in Pulmonary Tuberculosis

Clinical trial2025-10-06Results expected Q1 2027 · ClinicalTrials.gov

6 Months of Bedaquiline, Delamanid, Linezolid and Levoffoxacin in RR-TB Patients in Hubei Province

Clinical trial2025-09-30Results expected Q3 2027 · ClinicalTrials.gov

Phase 2C Clinical Trial of Novel, Short-course Regimens for the Treatment of Pulmonary Tuberculosis: CRUSH-TB (Combination Regimens for Shortening TB Treatment)

Clinical trial2025-09-19Results expected Q4 2026 · ClinicalTrials.gov

Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis：BDLL Chinese Cohort

Clinical trial2025-09-02Results expected Q1 2027 · ClinicalTrials.gov

Short-Course Regimen With Bedaquiline, Moxifloxacin and Pyrazinamide for Early Bactericidal Activity in Drug-Susceptible Tuberculosis

Clinical trial2025-08-19Results expected Q4 2026 · ClinicalTrials.gov

A Study on the Short-course Treatment Regimen Containing Pretomanid for Drug-resistant Tuberculosis

Clinical trial2025-08-17Results expected Q3 2027 · ClinicalTrials.gov

Approval: Deltyba (EMA)

Regulatory2014-04-27EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Delamanid

Aliases & brands

(2R)-2-methyl-6-nitro-2-((4-(4-(4-(trifluoromethoxy)phenoxy)piperidin-1-yl)phenoxy)methyl)-2,3-dihydroimidazo(2,1-B)(1,3)oxazoleImidazo(2,1-B)oxazole, 2,3-dihydro-2-methyl-6-nitro-2-((4-(4-(4-(trifluoromethoxy)phenoxy)-1-piperidinyl)phenoxy)methyl)-, (2R)-

RxNorm CUI

1344662

ChEMBL ID

CHEMBL218650

UNII

8OOT6M1PC7

Regulatory jurisdictions

ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2014-04-27

Latest approval

2014-04-27

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2014-04-27Approval

Approval: Deltyba (EMA)

Indication: Deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adults, adolescents, children and infants… Show full indication

Deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adults, adolescents, children and infants with a body weight of at least 10 kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see sections 4.2, 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

28 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

registered trials across all phases

LATEST COMPLETION 2026

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 28

Phase 11Phase 1 / 21Phase 216Phase 2 / 31Phase 36Phase 41Phase N / A2

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Safety and Effectiveness of Delamanid-containing Regimen for Treatment of Patients With Multidrug-resistant Tuberculosis in China

Unknown statusPH IVBeijing Chest Hospitaln=6082024

Phase 2C Clinical Trial of Novel, Short-course Regimens for the Treatment of Pulmonary Tuberculosis: CRUSH-TB (Combination Regimens for Shortening TB Treatment)

Active, not recruitingPH II/IIICenters for Disease Control and Preventionn=2882027

Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis：BDLL Chinese Cohort

Active, not recruitingPH IIIHuashan Hospitaln=1202027

Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIx MDR-TB)

Active, not recruitingPH IIIKey trialNational Institute of Allergy and Infectious Diseases (NIAID)n=5,8322027

A Multicenter, Randomized, Open-Label Study To Evaluate The Efficacy And Safety Of A Contezolid, Delamanid and Bedaquiline-Containing Short Regimen For The Treatment Of Rifampicin-Resistant Pulmonary Tuberculosis

Active, not recruitingPH IIIBeijing Chest Hospitaln=1862026

Recent completions

Trials that read out recently, adding to the completed evidence base.

CompletedPH IINational Institute of Allergy and Infectious Diseases (NIAID)n=1382026

CompletedPH I/IINational Institute of Allergy and Infectious Diseases (NIAID)n=372025

CompletedPH IIGlaxoSmithKlinen=1272025

Evaluating Newly Approved Drugs in Combination Regimens for Multidrug-Resistant TB With Fluoroquinolone Resistance (endTB-Q)

CompletedPH IIIMédecins Sans Frontières, Francen=3232024

A Multicenter, Phase 2b/c, Open-label, Randomized, Dose-finding Trial to Evaluate the Safety and Efficacy of a 4 Month Regimen of OPC-167832 in Combination With Delamanid and Bedaquiline in Subjects With Drug-susceptible Pulmonary Tuberculosis in Comparison With Standard Treatment

CompletedPH IIOtsuka Pharmaceutical Development & Commercialization, Inc.n=1222024

Evaluating Newly Approved Drugs for Multidrug-resistant TB (endTB): A Clinical Trial

CompletedPH IIIMédecins Sans Frontières, Francen=7542023

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.