Drugs / Delamanid
Delamanid
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Deltyba | — | 2014-04-27 | europa.eu ↗ |
| Refused (EMA) | EU (EMA) | Deltyba | — | 2013-07-25 | europa.eu ↗ |
Trials 31 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 7 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 26 trials | ||||||
| Phase 2 | NCT07170800 Comparator | Sep 2025 → Feb 2026 overdue | multidrug-resistant tuberculosis, rifampicin-resistant tuberculosis | WestVac Biopharma Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT06224036 Comparator | Oct 2023 → Mar 2024 | drug-resistant tuberculosis | Beijing Chest Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05926466 Background | Sep 2023 → Aug 2024 | pulmonary tuberculosis | Michael Hoelscher | Unknown | No outcome recorded |
| Phase 2 | NCT05007821 Background | Sep 2022 → Mar 2025 | multidrug-resistant tuberculosis, pulmonary tuberculosis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT04550832 Background | Oct 2021 → Jan 2023 | pulmonary tuberculosis | LigaChem Biosciences, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03959566 Background | May 2021 → Sep 2022 | pulmonary tuberculosis | Michael Hoelscher | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07126639 Comparator | Sep 2025 → Sep 2027 expected | — | Wuhan Pulmonary Hospital | Not yet recruiting | No outcome recorded |
Press releases naming this drug 17 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-10-06 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Announces Approval in EU of Pediatric, 25 mg Dispersible-Tablet Formulation of Deltyba™ for Multidrug-Resistant Tuberculosis otsuka.co.jp ↗ |
| 2021-08-10 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Awarded Grant for Phase 2 Trial Combining Novel Anti-Tuberculosis Compound OPC-167832 with Delamanid and Bedaquiline otsuka.co.jp ↗ |
| 2021-08-09 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Awarded Grant for Phase 2 Trial Combining Novel Anti-Tuberculosis Compound OPC-167832 with Delamanid and Bedaquiline otsuka-us.com ↗ |
| 2020-05-25 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Deltyba (delamanid) approved in Russian Federation for treatment of pulmonary multidrug-resistant tuberculosis (MDR-TB)® otsuka.co.jp ↗ |
| 2018-03-23 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka's DELTYBA Approved in China for the Treatment of Multidrug-resistant Tuberculosis otsuka.co.jp ↗ |
| 2018-01-29 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Awarded Grant to Advance Development of Novel Anti-Tuberculosis Compound OPC-167832 with Delamanid otsuka.co.jp ↗ |
| 2018-01-29 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Awarded Grant to Advance Development of Novel Anti-Tuberculosis Compound OPC-167832 with Delamanid otsuka-us.com ↗ |
| 2017-12-14 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Pharmaceutical Co., Ltd. Receives the Japan Medical R&D Grand Prize for Development of Delamanid, a Drug for Multidrug-resistant Tuberculosis Japanese Government Grants Award for the First Time otsuka.co.jp ↗ |
| 2016-02-25 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Announces Worldwide Access Plan for Delamanid with Stop TB Partnership's Global Drug Facility otsuka.co.jp ↗ |
| 2015-07-16 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Efficacy Results of Otsuka's Delamanid (Deltyba) for Extensively Drug-Resistant Tuberculosis (XDR-TB) Published in the New England Journal of Medicine™ otsuka.co.jp ↗ |
| 2014-09-08 | Otsuka Pharmaceutical Development & Commercialization, Inc. | A Change in the Treatment of Multidrug-Resistant Tuberculosis Begins New Antituberculosis Drug Deltyba in 50 mg Tablets, Available to Patients in Japan Starting September 26 ® otsuka.co.jp ↗ |
| 2014-07-04 | Otsuka Pharmaceutical Development & Commercialization, Inc. | After 40 Years, A New Drug For The Treatment Of Tuberculosis In Japan Deltyba (delamanid) Is The First Drug Approved In Japan Specifically For Pulmonary Multidrug-Resistant Tuberculosis (MDR-TB)® otsuka.co.jp ↗ |
| 2014-04-30 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Wins European Marketing Authorization for Deltyba (delamanid)™ otsuka.co.jp ↗ |
| 2013-11-25 | Otsuka Pharmaceutical Development & Commercialization, Inc. | CHMP Recommends Otsuka's Deltyba (delamanid) for EU Approval for Treatment of Multidrug-Resistant Tuberculosis (MDR-TB) in Combination with Optimized Background Regimen (OBR)™ otsuka.co.jp ↗ |
| 2013-07-26 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Receives Opinion from CHMP on Delamanid otsuka.co.jp ↗ |
| 2013-03-27 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka's Novel Treatment for Multidrug-Resistant Tuberculosis, Delamanid, Submitted For Regulatory Approval in Japan -- Half Century Since Last Drug Was Approved in Japan for Tuberculosis otsuka.co.jp ↗ |
| 2012-06-07 | Otsuka Pharmaceutical Development & Commercialization, Inc. | The New England Journal of Medicine Publishes Efficacy Results of Otsuka's Delamanid for Multidrug-Resistant Tuberculosis New Research Shows 53% Increase in Sputum Culture Conversion (SCC) After Two Months otsuka.co.jp ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 41 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Delamanid | “Delamanid (D or DLM) is added to the bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z), (BMZ) regimen for first 8 weeks and continued for next 9 weeks with bedaquiline...” NCT05766267 ↗36“The investigational MDR-END Plus regimen consists of oral anti-tuberculosis drugs including bedaquiline, delamanid, delpazolid, levofloxacin, and pyrazinamide.” NCT07675954 ↗ “PRS Regimen V(bedaquiline, delamanid, clofazimine, pyrazinamide)” NCT05278988 ↗ “Drug:delamanid 50mg tablets” NCT06476210 ↗ |
| Known as | Deltyba | ChEMBL registry synonym — accepted as the source's own label CHEMBL218650 ↗ |
| Known as | DLM | “Delamanid (D or DLM) is added to the bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z), (BMZ) regimen for first 8 weeks and continued for next 9 weeks with bedaquiline...” NCT05766267 ↗5“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 ↗ “This study aims to assess the efficacy and safety of a 24-week regimen that includes Delamanid (Dlm) for patients with these resistant forms of tuberculosis.” PMID 41419836 ↗ Dec 2025 “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 FQs - sensitive group was treated with the BDLL regimen (bedaquiline (BDQ), delamanid (DLM), linezolid (LZD), and levofloxacin (LFX))” NCT07126639 ↗ “Delamanid (DLM)” NCT03568383 ↗ |
| Known as | OPC-67683 | “A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial to Evaluate the Safety and Efficacy of Delamanid (OPC-67683) Administered Orally as...” NCT01424670 ↗ |
| Action | Inhibit | “inhibits mycolic acid synthesis” PMID 22670901 ↗ Jun 2012 |
| Modality | Small molecule | “Delamanid (OPC-67683), a nitro-dihydro-imidazooxazole derivative” PMID 22670901 ↗ Jun 2012 |
| Route | Oral | “OPC-67683, administered orally” NCT00401271 ↗ |