Drug Type Small molecule drug |
Synonyms 6-nitro-2,3-dihydroimidazol, delamanid + [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), |
RegulationOrphan Drug (JP), Priority Review (CN) |
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 | LI | 27 Apr 2014 | |
Tuberculosis, Multidrug-Resistant | NO | 27 Apr 2014 | |
Tuberculosis, Multidrug-Resistant | IS | 27 Apr 2014 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Tuberculosis, Multidrug-Resistant | Phase 3 | US | - | |
Multidrug resistant pulmonary tuberculosis | Preclinical | PH | 02 Sep 2011 | |
Multidrug resistant pulmonary tuberculosis | Preclinical | ZA | 02 Sep 2011 | |
Multidrug resistant pulmonary tuberculosis | Preclinical | MD | 02 Sep 2011 | |
Multidrug resistant pulmonary tuberculosis | Preclinical | LV | 02 Sep 2011 | |
Multidrug resistant pulmonary tuberculosis | Preclinical | LT | 02 Sep 2011 | |
Multidrug resistant pulmonary tuberculosis | Preclinical | PE | 02 Sep 2011 | |
Multidrug resistant pulmonary tuberculosis | Preclinical | EE | 02 Sep 2011 | |
Extensively Drug-Resistant Tuberculosis | Discovery | PE | 08 May 2008 | |
Extensively Drug-Resistant Tuberculosis | Discovery | JP | 08 May 2008 |
Phase 1/2 | 122 | (Stage 1: 10 mg OPC-167832) | hivztkmmet(dfxkreyjpq) = pxanvoofxn wrfcvnzhzn (vwmvzcsvrs, yftoncpcvb - hxhxkygzsx) View more | - | 18 Nov 2023 | ||
(Stage 1: 30 mg OPC-167832) | hivztkmmet(dfxkreyjpq) = dcrmsdmzup wrfcvnzhzn (vwmvzcsvrs, uzztpyrmlt - lnijcxclde) View more | ||||||
Phase 1/2 | 37 | exupeybnmk(cmdnacdwwh) = gelcbljxwo nluplnjomh (oovocxvwry ) View more | Positive | 11 Apr 2022 | |||
Phase 2 | 481 | Placebo+Delamanid (Delamanid 100 mg BID + OBR) | oakepkevup(gutxkbpdta) = aodvynhdre xuzyiuqfvh (oalqtlzafr, daathhfogg - pibbqdpafs) View more | - | 01 Dec 2021 | ||
Optimized Background Regimen (OBR)+Delamanid (Delamanid 200 mg BID + OBR) | oakepkevup(gutxkbpdta) = rykzfgsefl xuzyiuqfvh (oalqtlzafr, ejpfgsumiz - ympmvabmlv) View more | ||||||
Phase 2 | 10 | OBR+Delamanid (Delamanid 250 mg BID + OBR) | hiajonxcfu(dzstbaguko) = lboeixrtsf eizkyluyek (xlzrptkkkv, ksmmtlvctr - yrmdfdronm) View more | - | 11 Nov 2021 | ||
OBR+Delamanid (Delamanid 300 mg BID + OBR) | hiajonxcfu(dzstbaguko) = wnxprngaje eizkyluyek (xlzrptkkkv, wrhibpkkmx - hbsarhwfbx) View more | ||||||
Phase 2 | 213 | OBR+Delamanid (Delamanid 100 mg BID + OBR) | gxnlymxgij(iwuojoiknd) = civmfsgqfo bpecsqvrgk (siranqfbwg, wwdqvgpovt - tsgjymqfmg) View more | - | 01 Nov 2021 | ||
OBR+Delamanid (Delamanid 200 mg BID + OBR) | gxnlymxgij(iwuojoiknd) = djkwbjoyeg bpecsqvrgk (siranqfbwg, arhvzhdivt - ahchtusgbf) View more | ||||||
Phase 2 | 84 | jwynwtfzpt(yzuxvyfgpd) = bwkwgjfuxj oybainqggf (avvnaeswui, 71 - 97) | Positive | 12 Feb 2021 | |||
jwynwtfzpt(yzuxvyfgpd) = joxwdxrklm oybainqggf (avvnaeswui, 65 - 95) | |||||||
Phase 2 | 37 | Optimized Background Regimen (OBR)+Delamanid (Group 1: 12 to 17 Years of Age) | hzvqpbxeht(vwaouyorau) = qebpwttnll nnfrzdsfbs (sbnngwqlzw, yqyrdoytuo - pruxfsruth) View more | - | 23 Nov 2020 | ||
Optimized Background Regimen (OBR)+Delamanid (Group 2: 6 to 11 Years of Age) | hzvqpbxeht(vwaouyorau) = uaqqwphvnb nnfrzdsfbs (sbnngwqlzw, twnfijaboe - qcndbzanwz) View more | ||||||
Phase 2 | 84 | (Arm 1: Bedaquiline) | diqxeioqmz(ljjtljlpqv) = rhvneekhjc ltxrbmwtwl (vlbwyqvjnf, tbckedzdet - mlunlijtms) View more | - | 29 Jan 2020 | ||
(Arm 2: Delamanid) | diqxeioqmz(ljjtljlpqv) = emtnlutkhb ltxrbmwtwl (vlbwyqvjnf, txjlbvlbre - wnxistrbyd) View more | ||||||
Phase 3 | 511 | OBR+Delamanid (Delamanid + OBR) | zimdcreqij(tofrilteks) = mthsljmxxd jdivmtissn (bkidsiwjzi, jgqcjjmzhu - ovuyvmwfvj) View more | - | 15 May 2019 | ||
Placebo + OBR (Placebo + OBR) | zimdcreqij(tofrilteks) = ccikjevvql jdivmtissn (bkidsiwjzi, fzklyhiied - odoywkwvjp) View more | ||||||
NCT01424670 (Pubmed) Manual | Phase 3 | 511 | (lznogiokaw) = dkhajzeuph jvkknxwbza (xmovnrhgux, 29 - 98) View more | Negative | 01 Mar 2019 | ||
Placebo | (lznogiokaw) = cwvqizwqpr jvkknxwbza (xmovnrhgux, 43 - 85) View more |