Last update 07 Nov 2024

Delamanid

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
6-nitro-2,3-dihydroimidazol, delamanid, OPC-67683
+ [2]
Target-
Mechanism
Cell wall inhibitors, Mycolic acid synthesis inhibitors
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (KR), Priority Review (CN), Orphan Drug (JP)
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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
IS
27 Apr 2014
Tuberculosis, Multidrug-Resistant
LI
27 Apr 2014
Tuberculosis, Multidrug-Resistant
NO
27 Apr 2014
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Multidrug resistant pulmonary tuberculosisPhase 3
EE
02 Sep 2011
Multidrug resistant pulmonary tuberculosisPhase 3
LV
02 Sep 2011
Multidrug resistant pulmonary tuberculosisPhase 3
LT
02 Sep 2011
Multidrug resistant pulmonary tuberculosisPhase 3
MD
02 Sep 2011
Multidrug resistant pulmonary tuberculosisPhase 3
PE
02 Sep 2011
Multidrug resistant pulmonary tuberculosisPhase 3
PH
02 Sep 2011
Multidrug resistant pulmonary tuberculosisPhase 3
ZA
02 Sep 2011
HIV InfectionsPhase 2
BW
30 Jan 2018
HIV InfectionsPhase 2
IN
30 Jan 2018
HIV InfectionsPhase 2
ZA
30 Jan 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
37
dianauxltc(tatpfievws) = fggokndkhm spqvxqogrb (libvaybzsw )
Positive
11 Apr 2022
Phase 2
481
Placebo+Delamanid
(Delamanid 100 mg BID + OBR)
gpclfylbit(dbkhcszicn) = npcbydidzl wheystworu (cltmvgzthm, vzyphhiulx - loktewvpqp)
-
01 Dec 2021
Optimized Background Regimen (OBR)+Delamanid
(Delamanid 200 mg BID + OBR)
gpclfylbit(dbkhcszicn) = rmcnspysei wheystworu (cltmvgzthm, stnyfcukhu - semixqblqx)
Phase 2
10
(Delamanid 250 mg BID + OBR)
hhjzwtdnqm(vsxyionutq) = sdahfjeicp xrqevfcmpx (odcnvmsqjo, ganetczdfl - xqwnobgzqw)
-
11 Nov 2021
(Delamanid 300 mg BID + OBR)
hhjzwtdnqm(vsxyionutq) = rxxcjuxieg xrqevfcmpx (odcnvmsqjo, kmmztmbpjx - asnelovlwl)
Phase 2
213
(Delamanid 100 mg BID + OBR)
zecpgatjsc(pyrmpngjop) = imjlhzdurq pwufcudpmn (nekpdreoid, shiyeiruad - ivxroiqinl)
-
01 Nov 2021
(Delamanid 200 mg BID + OBR)
zecpgatjsc(pyrmpngjop) = qwrgsembhc pwufcudpmn (nekpdreoid, oerozopyir - ywpgmirled)
Phase 2
84
kholmakcvk(bwojahhyen) = rxnnvjfvfg rlxhklnqqn (ugevzxnihm, 71 - 97)
Positive
12 Feb 2021
kholmakcvk(bwojahhyen) = wqciilaycx rlxhklnqqn (ugevzxnihm, 65 - 95)
Phase 2
37
Optimized Background Regimen (OBR)+Delamanid
(Group 1: 12 to 17 Years of Age)
jrorxmoycm(ctprztbslk) = gstcfkwgsi rzqlqyynuo (vlrqpnimln, vsfwdostqc - donzmemfye)
-
23 Nov 2020
Optimized Background Regimen (OBR)+Delamanid
(Group 2: 6 to 11 Years of Age)
jrorxmoycm(ctprztbslk) = wqylqmruyd rzqlqyynuo (vlrqpnimln, owerxpklza - abtbcumwzr)
Phase 2
84
(Arm 1: Bedaquiline)
nyfwxwlkvo(vlgdaolrgx) = bogkktzxpo wozajtvnxv (mlrmsasvlf, joqjamyjvg - odqbmhtnal)
-
29 Jan 2020
(Arm 2: Delamanid)
nyfwxwlkvo(vlgdaolrgx) = hngdilrwdr wozajtvnxv (mlrmsasvlf, gurrpjmfdj - sesczuxsya)
Phase 3
511
(Delamanid + OBR)
ihfkxkwpjf(bsqslyhxzk) = rhrygjfett xkmphbywcb (usqzvnlarp, oqovsipcmt - usloytkzyd)
-
15 May 2019
Placebo + OBR
(Placebo + OBR)
ihfkxkwpjf(bsqslyhxzk) = zglmbkwcex xkmphbywcb (usqzvnlarp, enersmsrff - xcfvrmjsgp)
Phase 3
511
mnfwkffdkx(nutqopeser) = gwwocltytn ijmunrhlrm (gypbthvcpw, 29 - 98)
Negative
01 Mar 2019
Placebo
mnfwkffdkx(nutqopeser) = djhvhirsqn ijmunrhlrm (gypbthvcpw, 43 - 85)
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