Last update 21 Nov 2024

Delamanid

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
6-nitro-2,3-dihydroimidazol, delamanid
+ [5]
Target-
Mechanism
Cell wall inhibitors, Mycolic acid synthesis inhibitors
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (JP), Priority Review (CN)
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Structure

Molecular FormulaC25H25F3N4O6
InChIKeyXDAOLTSRNUSPPH-XMMPIXPASA-N
CAS Registry681492-22-8

External Link

KEGGWikiATCDrug Bank
D09785Delamanid

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Tuberculosis, Multidrug-ResistantPhase 3
US
-
Multidrug resistant pulmonary tuberculosisPreclinical
PH
02 Sep 2011
Multidrug resistant pulmonary tuberculosisPreclinical
ZA
02 Sep 2011
Multidrug resistant pulmonary tuberculosisPreclinical
MD
02 Sep 2011
Multidrug resistant pulmonary tuberculosisPreclinical
LV
02 Sep 2011
Multidrug resistant pulmonary tuberculosisPreclinical
LT
02 Sep 2011
Multidrug resistant pulmonary tuberculosisPreclinical
PE
02 Sep 2011
Multidrug resistant pulmonary tuberculosisPreclinical
EE
02 Sep 2011
Extensively Drug-Resistant TuberculosisDiscovery
PE
08 May 2008
Extensively Drug-Resistant TuberculosisDiscovery
JP
08 May 2008
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
122
(Stage 1: 10 mg OPC-167832)
hivztkmmet(dfxkreyjpq) = pxanvoofxn wrfcvnzhzn (vwmvzcsvrs, yftoncpcvb - hxhxkygzsx)
-
18 Nov 2023
(Stage 1: 30 mg OPC-167832)
hivztkmmet(dfxkreyjpq) = dcrmsdmzup wrfcvnzhzn (vwmvzcsvrs, uzztpyrmlt - lnijcxclde)
Phase 1/2
37
exupeybnmk(cmdnacdwwh) = gelcbljxwo nluplnjomh (oovocxvwry )
Positive
11 Apr 2022
Phase 2
481
Placebo+Delamanid
(Delamanid 100 mg BID + OBR)
oakepkevup(gutxkbpdta) = aodvynhdre xuzyiuqfvh (oalqtlzafr, daathhfogg - pibbqdpafs)
-
01 Dec 2021
Optimized Background Regimen (OBR)+Delamanid
(Delamanid 200 mg BID + OBR)
oakepkevup(gutxkbpdta) = rykzfgsefl xuzyiuqfvh (oalqtlzafr, ejpfgsumiz - ympmvabmlv)
Phase 2
10
(Delamanid 250 mg BID + OBR)
hiajonxcfu(dzstbaguko) = lboeixrtsf eizkyluyek (xlzrptkkkv, ksmmtlvctr - yrmdfdronm)
-
11 Nov 2021
(Delamanid 300 mg BID + OBR)
hiajonxcfu(dzstbaguko) = wnxprngaje eizkyluyek (xlzrptkkkv, wrhibpkkmx - hbsarhwfbx)
Phase 2
213
(Delamanid 100 mg BID + OBR)
gxnlymxgij(iwuojoiknd) = civmfsgqfo bpecsqvrgk (siranqfbwg, wwdqvgpovt - tsgjymqfmg)
-
01 Nov 2021
(Delamanid 200 mg BID + OBR)
gxnlymxgij(iwuojoiknd) = djkwbjoyeg bpecsqvrgk (siranqfbwg, arhvzhdivt - ahchtusgbf)
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)
-
23 Nov 2020
Optimized Background Regimen (OBR)+Delamanid
(Group 2: 6 to 11 Years of Age)
hzvqpbxeht(vwaouyorau) = uaqqwphvnb nnfrzdsfbs (sbnngwqlzw, twnfijaboe - qcndbzanwz)
Phase 2
84
(Arm 1: Bedaquiline)
diqxeioqmz(ljjtljlpqv) = rhvneekhjc ltxrbmwtwl (vlbwyqvjnf, tbckedzdet - mlunlijtms)
-
29 Jan 2020
(Arm 2: Delamanid)
diqxeioqmz(ljjtljlpqv) = emtnlutkhb ltxrbmwtwl (vlbwyqvjnf, txjlbvlbre - wnxistrbyd)
Phase 3
511
(Delamanid + OBR)
zimdcreqij(tofrilteks) = mthsljmxxd jdivmtissn (bkidsiwjzi, jgqcjjmzhu - ovuyvmwfvj)
-
15 May 2019
Placebo + OBR
(Placebo + OBR)
zimdcreqij(tofrilteks) = ccikjevvql jdivmtissn (bkidsiwjzi, fzklyhiied - odoywkwvjp)
Phase 3
511
(lznogiokaw) = dkhajzeuph jvkknxwbza (xmovnrhgux, 29 - 98)
Negative
01 Mar 2019
Placebo
(lznogiokaw) = cwvqizwqpr jvkknxwbza (xmovnrhgux, 43 - 85)
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Regulation

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