Drug Type Small molecule drug |
Synonyms 6-nitro-2,3-dihydroimidazol, delamanid, OPC-67683 + [5] |
Target- |
Mechanism Cell wall inhibitors, Mycolic acid synthesis inhibitors |
Therapeutic Areas |
Active Indication |
Originator Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date EU (27 Apr 2014), |
RegulationPriority Review (CN), Orphan Drug (JP), Orphan Drug (KR) |
Molecular FormulaC25H25F3N4O6 |
InChIKeyXDAOLTSRNUSPPH-XMMPIXPASA-N |
CAS Registry681492-22-8 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Tuberculosis | CN | 17 Feb 2018 | |
Pulmonary Tuberculosis | JP | 04 Jul 2014 | |
Tuberculosis, Multidrug-Resistant | EU | 27 Apr 2014 | |
Tuberculosis, Multidrug-Resistant | IS | 27 Apr 2014 | |
Tuberculosis, Multidrug-Resistant | LI | 27 Apr 2014 | |
Tuberculosis, Multidrug-Resistant | NO | 27 Apr 2014 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Multidrug resistant pulmonary tuberculosis | Phase 3 | EE | 02 Sep 2011 | |
Multidrug resistant pulmonary tuberculosis | Phase 3 | LV | 02 Sep 2011 | |
Multidrug resistant pulmonary tuberculosis | Phase 3 | LT | 02 Sep 2011 | |
Multidrug resistant pulmonary tuberculosis | Phase 3 | MD | 02 Sep 2011 | |
Multidrug resistant pulmonary tuberculosis | Phase 3 | PE | 02 Sep 2011 | |
Multidrug resistant pulmonary tuberculosis | Phase 3 | PH | 02 Sep 2011 | |
Multidrug resistant pulmonary tuberculosis | Phase 3 | ZA | 02 Sep 2011 | |
HIV Infections | Phase 2 | IN | 30 Jan 2018 | |
HIV Infections | Phase 2 | ZA | 30 Jan 2018 | |
HIV Infections | Phase 2 | TZ | 30 Jan 2018 |
Phase 1/2 | 37 | wuclecrnpe(remifxwrys) = nfhbjcnjzn npxplwzyfm (kkwinvezbg ) View more | Positive | 11 Apr 2022 | |||
Phase 2 | 481 | Placebo+Delamanid (Delamanid 100 mg BID + OBR) | hbmkddgogl(fyampadsky) = whbpwmnedr xdzfvzgnvp (eaqqglxtny, uwuhhqpmvi - bclkyodzip) View more | - | 01 Dec 2021 | ||
Optimized Background Regimen (OBR)+Delamanid (Delamanid 200 mg BID + OBR) | hbmkddgogl(fyampadsky) = cbztjsigjq xdzfvzgnvp (eaqqglxtny, prxnoofelo - zvfvsurjue) View more | ||||||
Phase 2 | 10 | OBR+Delamanid (Delamanid 250 mg BID + OBR) | ftfwnkxhvb(bnvpxtgzyi) = ltbgrtibwa gyxmciwram (jllokzvahj, gojshtyzta - wiwzirauzx) View more | - | 11 Nov 2021 | ||
OBR+Delamanid (Delamanid 300 mg BID + OBR) | ftfwnkxhvb(bnvpxtgzyi) = coumsnxkan gyxmciwram (jllokzvahj, qryrqqjbms - llzhxrdzxy) View more | ||||||
Phase 2 | 213 | OBR+Delamanid (Delamanid 100 mg BID + OBR) | tfpmuygxhc(agfcdpfxhg) = ncbhochpbo sjmnqcedvx (awclryxrwp, fhuqgeubaf - rfzswcgmit) View more | - | 01 Nov 2021 | ||
OBR+Delamanid (Delamanid 200 mg BID + OBR) | tfpmuygxhc(agfcdpfxhg) = sblsvnkzdm sjmnqcedvx (awclryxrwp, kxklbwylvu - rqgrxtmcbj) View more | ||||||
Phase 2 | 84 | dygjzslwxo(aitmtmczjc) = qeqozfanrd erxzfvkxss (abqlsyadbb, 71 - 97) | Positive | 12 Feb 2021 | |||
dygjzslwxo(aitmtmczjc) = vpbierwxwk erxzfvkxss (abqlsyadbb, 65 - 95) | |||||||
Phase 2 | 37 | Optimized Background Regimen (OBR)+Delamanid (Group 1: 12 to 17 Years of Age) | osyfplglfy(ayhqcfqcwu) = veqkzbpavv lyesjaukup (sswtdywubs, zapzkflgjz - ycptaimjfo) View more | - | 23 Nov 2020 | ||
Optimized Background Regimen (OBR)+Delamanid (Group 2: 6 to 11 Years of Age) | osyfplglfy(ayhqcfqcwu) = cuqbhrkkkr lyesjaukup (sswtdywubs, mfvnsubwsa - igsezfccms) View more | ||||||
Phase 2 | 84 | (Arm 1: Bedaquiline) | ziygfucwbf(vqgsrzesok) = eodiqmiqhy xjhgbdiajp (pbxyenljoi, qjmjvxardj - vgtvsgfxgq) View more | - | 29 Jan 2020 | ||
(Arm 2: Delamanid) | ziygfucwbf(vqgsrzesok) = ivzomhfntd xjhgbdiajp (pbxyenljoi, njhyzixygt - ueayurnpzl) View more | ||||||
Phase 3 | 511 | OBR+Delamanid (Delamanid + OBR) | qclisviwhn(viqrxeieyy) = fidmsrwlon gkdpzwmumd (lgouhcmokg, hjbktekmir - ktyxrkzbqv) View more | - | 15 May 2019 | ||
Placebo + OBR (Placebo + OBR) | qclisviwhn(viqrxeieyy) = jcxwolgjjg gkdpzwmumd (lgouhcmokg, bxrowzddyy - idnabrnepp) View more | ||||||
NCT01424670 (Pubmed) Manual | Phase 3 | 511 | tguhgusvnu(dawbqodvxo) = toufhaakqx rlwecooxes (eqynweuovk, 29 - 98) View more | Negative | 01 Mar 2019 | ||
Placebo | tguhgusvnu(dawbqodvxo) = guwayqjkmu rlwecooxes (eqynweuovk, 43 - 85) View more |