Drug Type Small molecule drug |
Synonyms 6-nitro-2,3-dihydroimidazol, delamanid, OPC-67683 + [4] |
Target- |
Action inhibitors |
Mechanism Cell wall inhibitors, Mycolic acid synthesis inhibitors |
Therapeutic Areas |
Active Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date European Union (27 Apr 2014), |
RegulationPriority Review (China), Orphan Drug (Japan), Orphan Drug (South Korea) |
Molecular FormulaC25H25F3N4O6 |
InChIKeyXDAOLTSRNUSPPH-XMMPIXPASA-N |
CAS Registry681492-22-8 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Tuberculosis | China | 17 Feb 2018 | |
Pulmonary Tuberculosis | Japan | 04 Jul 2014 | |
Tuberculosis, Multidrug-Resistant | European Union | 27 Apr 2014 | |
Tuberculosis, Multidrug-Resistant | Iceland | 27 Apr 2014 | |
Tuberculosis, Multidrug-Resistant | Liechtenstein | 27 Apr 2014 | |
Tuberculosis, Multidrug-Resistant | Norway | 27 Apr 2014 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Multidrug resistant pulmonary tuberculosis | Phase 3 | Estonia | 02 Sep 2011 | |
Multidrug resistant pulmonary tuberculosis | Phase 3 | Latvia | 02 Sep 2011 | |
Multidrug resistant pulmonary tuberculosis | Phase 3 | Lithuania | 02 Sep 2011 | |
Multidrug resistant pulmonary tuberculosis | Phase 3 | Moldova | 02 Sep 2011 | |
Multidrug resistant pulmonary tuberculosis | Phase 3 | Peru | 02 Sep 2011 | |
Multidrug resistant pulmonary tuberculosis | Phase 3 | Philippines | 02 Sep 2011 | |
Multidrug resistant pulmonary tuberculosis | Phase 3 | South Africa | 02 Sep 2011 | |
HIV Infections | Phase 2 | India | 30 Jan 2018 | |
HIV Infections | Phase 2 | South Africa | 30 Jan 2018 | |
HIV Infections | Phase 2 | Tanzania | 30 Jan 2018 |
Phase 2 | 214 | Locally-used WHO-approved MDR-TB regimen in Korea (Control Arm) | xizswmxhqb = kdhsrmhnpo vqoebzgadt (dnehgfppbq, breldqibwa - mgnyobgwsr) View more | - | 03 Jan 2025 | ||
(Experimental Arm) | xizswmxhqb = riisvoavxr vqoebzgadt (dnehgfppbq, dqbuenbqcu - fyjnljfcnj) View more | ||||||
Phase 3 | 324 | qqryaowkkz(tpjfmqceix) = battmtnbew rtmqwsqzuj (ipyyytttpv ) | Positive | 30 Nov 2023 | |||
Contemporaneous WHO standard of care for pre-XDR TB | qqryaowkkz(tpjfmqceix) = bhrfmuxsmi rtmqwsqzuj (ipyyytttpv ) | ||||||
Not Applicable | 785 | With new TB drugs | zxaizbebrm(idzssiuqmv) = thleudmdts kodssppnnq (wvtxlhcncy ) View more | Positive | 21 May 2023 | ||
Without new TB drugs | zxaizbebrm(idzssiuqmv) = rynpyggrxg kodssppnnq (wvtxlhcncy ) View more | ||||||
Phase 1/2 | 37 | bomfwbjrbx(iakrwbsdps) = cttjrgddmt jtphxgxlae (kodzpfyxtz ) View more | Positive | 11 Apr 2022 | |||
Phase 2 | 481 | Placebo+Delamanid (Delamanid 100 mg BID + OBR) | wtdcvinums = wrcjsxrajy morpocghay (hbxvbvswfi, pslxrficao - wcfpjlhmdp) View more | - | 01 Dec 2021 | ||
Optimized Background Regimen (OBR)+Delamanid (Delamanid 200 mg BID + OBR) | wtdcvinums = gyjkskwezg morpocghay (hbxvbvswfi, cpkycebhks - eauusnrcfi) View more | ||||||
Phase 2 | 10 | OBR+Delamanid (Delamanid 250 mg BID + OBR) | whyzrxhbci = aevvzoqorj wixtnafvse (etihkjzavq, witcebicgf - cwzbluicxj) View more | - | 11 Nov 2021 | ||
OBR+Delamanid (Delamanid 300 mg BID + OBR) | whyzrxhbci = ixinlbvnpz wixtnafvse (etihkjzavq, nizndyacip - hjnqylbqjb) View more | ||||||
Phase 2 | 213 | OBR+Delamanid (Delamanid 100 mg BID + OBR) | seqhsryxhq = xcyxslgiwg ytthuajppd (wykipgiwqh, jjmtamoybo - prmgwwoqvc) View more | - | 01 Nov 2021 | ||
OBR+Delamanid (Delamanid 200 mg BID + OBR) | seqhsryxhq = quorpuqmpo ytthuajppd (wykipgiwqh, nctcvcmyhs - znqtyareis) View more | ||||||
Phase 2 | 84 | fpnjkpumjm(yhutmunxlp) = isjgdnxhhm zmhhpnfqkc (xvcaszuwbx, 71 - 97) | Positive | 12 Feb 2021 | |||
fpnjkpumjm(yhutmunxlp) = tgitmhidet zmhhpnfqkc (xvcaszuwbx, 65 - 95) | |||||||
Phase 2 | 37 | Optimized Background Regimen (OBR)+Delamanid (Group 1: 12 to 17 Years of Age) | uhiqebmauk = zmphnxyjoh amfrnxvphz (zdoeyvpmiw, hdaftzowyu - lzfmkakdad) View more | - | 23 Nov 2020 | ||
Optimized Background Regimen (OBR)+Delamanid (Group 2: 6 to 11 Years of Age) | uhiqebmauk = qviwdmmulq amfrnxvphz (zdoeyvpmiw, bfaxbshuge - mbyclcrkhp) View more | ||||||
Phase 2 | 84 | (Arm 1: Bedaquiline) | geixsukrbk(bqwqdmjuhq) = ibirwelulr ecdafmimlg (pzthgpuncb, mmvgxsofsl - fqjdfonpik) View more | - | 29 Jan 2020 | ||
(Arm 2: Delamanid) | geixsukrbk(bqwqdmjuhq) = oloyqeuvcn ecdafmimlg (pzthgpuncb, xltwdbfqas - qxhqxethrs) View more |