Drugs / Delamanid
Delamanid
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed primary pulmonary tuberculosis 3 milestones | |||||
| Refused (EMA) | EU (EMA) | Deltyba | primary pulmonary tuberculosis | 2013-07-25 | “the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion for delamanid” otsuka.co.jp ↗ authority europa.eu ↗ |
| Filed | Japan (PMDA) | — | primary pulmonary tuberculosis | 2013-03-27 | “filed an application with the Pharmaceutical and Medical Devices Agency in Japan (PMDA) to market its novel compound delamanid” otsuka.co.jp ↗ |
| Filed | EU (EMA) | — | primary pulmonary tuberculosis | — | “A Marketing Authorization Application (MAA) is currently under review by the European Medicines Agency (EMA)” otsuka.co.jp ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Deltyba | — | 2014-04-27 | europa.eu ↗ |
Trials 31
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2025-12-16 | MicuRx | Results “世界肺部健康大会”传佳音 含康替唑胺的创新抗结核方案绽光彩 micurx.com ↗
INSPIRE-CODA研究团队纳入的212例患者的临床数据显示，含康替唑胺的创新短程方案不仅早期疗效非劣于传统长程方案，更在安全性上实现突破——神经系统与血液系统不良反应发生率较传统方案显著降低。 |
| 2024-03-22 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results Otsuka Announces Interim Data from Phase 2b/c Trial Indicating New Investigational Compound May Shorten Tuberculosis Treatment otsuka.co.jp ↗
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. |
| 2024-03-21 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results Otsuka Announces Interim Data from Phase 2b/c Trial Indicating New Investigational Compound May Shorten Tuberculosis Treatment otsuka-us.com ↗
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. |
| 2021-10-06 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka Announces Approval in EU of Pediatric, 25 mg Dispersible-Tablet Formulation of Deltyba™ for Multidrug-Resistant Tuberculosis otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. (Otsuka Pharmaceutical) is pleased to announce that Otsuka Novel Products GmbH, a Germany based subsidiary of Otsuka Pharmaceutical, has obtained regulatory approval from the European Commission for the Deltyba™ (delamanid) 25-mg dispersible tablet formulation. |
| 2020-05-25 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Deltyba (delamanid) approved in Russian Federation for treatment of pulmonary multidrug-resistant tuberculosis (MDR-TB)® otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that the oral anti-tuberculosis (TB) drug Deltyba (delamanid) has been approved in Russia. |
| 2020-05-24 | R-Pharm | Regulatory Дельтиба (деламанид) одобрен в РФ для лечения туберкулеза с множественной лекарственной устойчивостью r-pharm.com ↗ |
| 2018-03-23 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka's DELTYBA Approved in China for the Treatment of Multidrug-resistant Tuberculosis otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. announces that on March 12, DELTYBA Tablets 50 mg (generic name: delamanid) received regulatory approval by the China Food and Drug Administration. |
| 2015-07-16 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results 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 ↗
The analysis found that patients receiving delamanid, plus a World Health Organization (WHO)- recommended optimized background regimen (OBR), had a higher proportion of 2-month sputum culture conversion (SCC), a measurement by which patients are no longer infectious, compared to patients receiving placebo plus OBR alone (7/16, 43.8% vs. 1/10, 10%, p=0.0989). |
| 2014-07-04 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory 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 ↗
Otsuka Pharmaceutical Co., Ltd. (Otsuka) today received regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for Deltyba (delamanid) as part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis (MDR-TB) in adult patients. |
| 2014-04-30 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka Wins European Marketing Authorization for Deltyba (delamanid)™ otsuka.co.jp ↗
First grant of a marketing authorization of Otsuka's novel drug for multidrug-resistant tuberculosis (MDR-TB). |
| 2013-11-25 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory 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 ↗
Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approval of DeltybaTM (delamanid) in combination with a WHO recommended optimized background regimen (OBR) for the treatment of pulmonary multidrug-resistant tuberculosis (MDR-TB) . |
| 2013-07-26 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka Receives Opinion from CHMP on Delamanid otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion for delamanid for the treatment of pulmonary multidrug-resistant tuberculosis (MDR-TB) in combination with an optimised background regimen (OBR) according to WHO guidelines in patients. |
| 2013-03-27 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory 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 ↗
Delamanid, discovered and developed by Otsuka, has been filed in Japan for the treatment of multidrug-resistant tuberculosis (MDR-TB), following the application in Europe in 2011. |
| 2012-06-07 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results 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 ↗
Phase IIb trial showed delamanid plus a background regimen rendered more study subjects non-infectious after two months than placebo plus background regimen alone. |
All press releases naming this drug 21 releases
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 | “The investigational MDR-END Plus regimen consists of oral anti-tuberculosis drugs including bedaquiline, delamanid, delpazolid, levofloxacin, and pyrazinamide.” NCT07675954 ↗36“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 ↗ |