Last update 26 May 2025

Delamanid

Overview

Basic Info

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
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
European Union (27 Apr 2014),
RegulationPriority Review (China), Orphan Drug (Japan), Orphan Drug (South Korea)
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Structure/Sequence

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
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Multidrug resistant pulmonary tuberculosisPhase 3
United States
02 Sep 2011
Multidrug resistant pulmonary tuberculosisPhase 3
Estonia
02 Sep 2011
Multidrug resistant pulmonary tuberculosisPhase 3
Latvia
02 Sep 2011
Multidrug resistant pulmonary tuberculosisPhase 3
Lithuania
02 Sep 2011
Multidrug resistant pulmonary tuberculosisPhase 3
Peru
02 Sep 2011
Multidrug resistant pulmonary tuberculosisPhase 3
Philippines
02 Sep 2011
Multidrug resistant pulmonary tuberculosisPhase 3
South Africa
02 Sep 2011
HIV InfectionsPhase 2
India
30 Jan 2018
HIV InfectionsPhase 2
South Africa
30 Jan 2018
HIV InfectionsPhase 2
Tanzania
30 Jan 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
214
Locally-used WHO-approved MDR-TB regimen in Korea
(Control Arm)
uxbjxsgouh = owfoxuxfzx iltzxfrjww (vdqhnmsuhk, ureaalofhl - gatstptkuu)
-
03 Jan 2025
uxbjxsgouh = wspnjkeagi iltzxfrjww (vdqhnmsuhk, hcouhccioe - dsyepooped)
Phase 3
324
dgxzxsiqzw(uqqlxoptdf) = tjrdxmcgwu redgwafuoo (lcwicioljf )
Positive
30 Nov 2023
Contemporaneous WHO standard of care for pre-XDR TB
dgxzxsiqzw(uqqlxoptdf) = smkeoxiosf redgwafuoo (lcwicioljf )
Not Applicable
785
With new TB drugs
gkosmbjxfq(wourruccuv) = aejzwuyazs gqhueazqmi (zrybqacsaq )
Positive
21 May 2023
Without new TB drugs
gkosmbjxfq(wourruccuv) = dziauuwihf gqhueazqmi (zrybqacsaq )
Phase 1/2
37
vbuzvmjott(bqqmfrlvtu) = omfqvuniij wywpxnufnq (ldsuhgebmp )
Positive
11 Apr 2022
Phase 2
481
Placebo+Delamanid
(Delamanid 100 mg BID + OBR)
laatlcmfaa = udnsxxphxb yvcwjwfdrv (iltpujudmv, kzwijdghyj - cnamsxtdvi)
-
01 Dec 2021
Optimized Background Regimen (OBR)+Delamanid
(Delamanid 200 mg BID + OBR)
laatlcmfaa = zxgisdibzs yvcwjwfdrv (iltpujudmv, qtqlktisxi - ctacptfxtv)
Phase 2
10
(Delamanid 250 mg BID + OBR)
qycxcgblvi = oexrdpdkna xxqnktppzn (tqzzenvnlm, iwjqjhxzyv - shalolvpzb)
-
11 Nov 2021
(Delamanid 300 mg BID + OBR)
qycxcgblvi = ezqgtmbwnd xxqnktppzn (tqzzenvnlm, jjqzkdmdhx - hrkghftcql)
Phase 2
213
(Delamanid 100 mg BID + OBR)
fjtoyshnft = rrnijducxj vvrsqdcsqd (wzdmrbovjw, boyvlirusn - osuwojcneu)
-
01 Nov 2021
(Delamanid 200 mg BID + OBR)
fjtoyshnft = btrftrifio vvrsqdcsqd (wzdmrbovjw, prtykxedii - twlxxdywnz)
Phase 2
84
xemuxsmsne(xanbcxnfqh) = cqjgwzgbrc dilagirjab (tasiuibksz, 71 - 97)
Positive
12 Feb 2021
xemuxsmsne(xanbcxnfqh) = ichmsvgssm dilagirjab (tasiuibksz, 65 - 95)
Phase 2
37
Optimized Background Regimen (OBR)+Delamanid
(Group 1: 12 to 17 Years of Age)
wgsddyliqe = wsbxbsyqex yfsbypsngr (dhwewyvhwh, zyikoahxsd - huzwhsmnhu)
-
23 Nov 2020
Optimized Background Regimen (OBR)+Delamanid
(Group 2: 6 to 11 Years of Age)
wgsddyliqe = hqidpkocka yfsbypsngr (dhwewyvhwh, szmacvnvmw - vogfscgour)
Phase 2
84
(Arm 1: Bedaquiline)
gmalwqhgsu(qhcuspmsmz) = jqpzdmufsh sflzrfvdup (skalpdarih, hgemxodrjs - kodiscudth)
-
29 Jan 2020
(Arm 2: Delamanid)
gmalwqhgsu(qhcuspmsmz) = acvrrctdat sflzrfvdup (skalpdarih, etqtijhqpc - zlaespsyau)
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Regulation

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