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DELAMANID
Delamanid is a marketed drug with a key composition patent expiring in 2028, positioning it as an established player in its therapeutic area. Its primary strength lies in its unique mechanism of action, which differentiates it from existing treatments. The primary risk is the patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | DELAMANID |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2014 |
Approved indications
Common side effects
Key clinical trials
- Ultra-Short Course Bedaquiline, Clofazimine, Pyrazinamide and Delamanid Versus Standard Therapy for Drug-Susceptible TB (PHASE2)
- A Phase 2b Clinical Study of JDB0131 Benzenesulfonate Tablets (PHASE2)
- Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
- Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum
- Early Bactericidal Activity, Safety & Tolerability of Oral GSK3036656 in a Dual Combination With Novel and Established Antitubercular Agents, or Standard of Care in Adults With Rifampicin Susceptible Pulmonary Tuberculosis (PHASE2)
- Platform Assessing Regimens and Durations In a Global Multisite Consortium for TB (PHASE2)
- 6 Months of Bedaquiline(BDQ), Delamanid(DLM), Linezolid(LZD) and Levofloxacin(LFX) in RR-TB Patients in Hubei Province (NA)
- Short-course Regimens for the Treatment of Pulmonary Tuberculosis (PHASE2, PHASE3)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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 CI brief — competitive landscape report
- DELAMANID updates RSS · CI watch RSS