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Delamanid + OBR
Delamanid + OBR is a Nitro-imidazole antimycobacterial agent Small molecule drug developed by Otsuka Pharmaceutical Development & Commercialization, Inc.. It is currently in Phase 3 development for Drug-resistant tuberculosis (MDR-TB and XDR-TB) in combination with optimized background regimen.
Delamanid inhibits mycobacterial cell wall synthesis by targeting mycolic acid production, while OBR (optimized background regimen) provides synergistic anti-tuberculous activity through multiple complementary mechanisms.
Delamanid inhibits mycobacterial cell wall synthesis by targeting mycolic acid production, while OBR (optimized background regimen) provides synergistic anti-tuberculous activity through multiple complementary mechanisms. Used for Drug-resistant tuberculosis (MDR-TB and XDR-TB) in combination with optimized background regimen.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Delamanid + OBR |
|---|---|
| Sponsor | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| Drug class | Nitro-imidazole antimycobacterial agent |
| Target | Mycolic acid biosynthesis pathway (mycobacterial cell wall) |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Delamanid is a nitro-imidazole prodrug that is activated by mycobacterial enzymes to form reactive intermediates that inhibit the synthesis of mycolic acids, critical components of the Mycobacterium tuberculosis cell wall. When combined with an optimized background regimen of standard anti-TB drugs, this combination approach targets drug-resistant tuberculosis through multiple pathways, improving treatment efficacy and reducing the risk of resistance development.
Approved indications
- Drug-resistant tuberculosis (MDR-TB and XDR-TB) in combination with optimized background regimen
Common side effects
- Peripheral neuropathy
- QT prolongation
- Gastrointestinal disturbances
- Hepatotoxicity
Key clinical trials
- Evaluating the Pharmacokinetics, Safety, and Tolerability of Delamanid in Combination With Optimized Multidrug Background Regimen (OBR) for Multidrug-Resistant Tuberculosis (MDR-TB) in HIV-Infected and HIV-Uninfected Children With MDR-TB (PHASE1, PHASE2)
- A Trial to Evaluate OPC 67683 in Participants With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis (TB) (PHASE2)
- Safety and Pharmacokinetics (PK) in Multidrug-Resistant (MDR) Refractive Tuberculosis (PHASE2)
- A Trial to Evaluate Safety, Tolerability, and Efficacy of Orally Administered OPC-67683 (PHASE2)
- A 6-Month Safety, Efficacy, and Pharmacokinetic (PK) Trial of Delamanid in Pediatric Participants With Multidrug Resistant Tuberculosis (MDR-TB) (PHASE2)
- Safety and Efficacy Trial of Delamanid for 6 Months in Participants With Multidrug-resistant Tuberculosis (PHASE3)
- Pharmacokinetic and Safety Trial to Determine the Appropriate Dose for Pediatric Patients With Multidrug Resistant Tuberculosis (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Delamanid + OBR CI brief — competitive landscape report
- Delamanid + OBR updates RSS · CI watch RSS
- Otsuka Pharmaceutical Development & Commercialization, Inc. portfolio CI
Frequently asked questions about Delamanid + OBR
What is Delamanid + OBR?
How does Delamanid + OBR work?
What is Delamanid + OBR used for?
Who makes Delamanid + OBR?
What drug class is Delamanid + OBR in?
What development phase is Delamanid + OBR in?
What are the side effects of Delamanid + OBR?
What does Delamanid + OBR target?
Related
- Drug class: All Nitro-imidazole antimycobacterial agent drugs
- Target: All drugs targeting Mycolic acid biosynthesis pathway (mycobacterial cell wall)
- Manufacturer: Otsuka Pharmaceutical Development & Commercialization, Inc. — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Drug-resistant tuberculosis (MDR-TB and XDR-TB) in combination with optimized background regimen
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing