Last update 03 Oct 2024

Nelitolimod

Overview

Basic Info

Drug Type
CpG ODN
Synonyms
Nelitolimod Sodium, ISS-ODN SD-101, SD 101
+ [4]
Target
Mechanism
TLR9 agonists(Toll like receptor 9 agonists), Immunostimulants
Originator Organization
Drug Highest PhasePhase 2
First Approval Date-
Regulation-

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Epidermolysis BullosaPhase 3
US
11 Mar 2015
Epidermolysis BullosaPhase 3
AU
11 Mar 2015
Epidermolysis BullosaPhase 3
AT
11 Mar 2015
Epidermolysis BullosaPhase 3
FR
11 Mar 2015
Epidermolysis BullosaPhase 3
DE
11 Mar 2015
Epidermolysis BullosaPhase 3
IL
11 Mar 2015
Epidermolysis BullosaPhase 3
IT
11 Mar 2015
Epidermolysis BullosaPhase 3
LT
11 Mar 2015
Epidermolysis BullosaPhase 3
NL
11 Mar 2015
Epidermolysis BullosaPhase 3
PL
11 Mar 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
3
ihmenlrncx(yebvqvrmgz) = SD-101: 1 patient, Placebo: 0 patients fqghzqsjsb (ydhdgdzdsb )
Positive
02 Nov 2023
Phase 1
Metastatic melanoma
TLR9 agonist | MDSC | ctDNA
53
SD-101 + nivolumab + ipilimumab
gkuvafebye(fkllpcniov) = Serious grade 3/4 treatment-related AEs (TRAEs) to SD-101 or ICI were documented in 8% of subjects: 0% in Cohort A, 4% in Cohort B, and 20% in Cohort C, with an overall Grade 3/4 TRAE rate of 21% lkhggllmaq (zexbuzistp )
Positive
31 Oct 2023
Phase 1
30
fnhistmklq(dndpfyaxpt) = pxtnpaomfk zykdawuxfu (gasevnxvyd )
Positive
31 May 2023
Phase 1
20
oinnbyqeti(fivlwmxceh) = svnfobsvhw kaoebrtulx (hwbzynjtbp )
-
04 Apr 2023
Phase 1/2
20
Radiotherapy+SD-101+epacadostat
tgoakjpfgt(exbqbyxdxs) = uvkjeazurb fgvukhxqcl (zzghncyddk, oaempddkjr - jspsdauquz)
-
21 Dec 2021
Phase 3
169
sgqsyildcm(uklhayduky): OR = 0.733 (95% CI, 0.365 - 1.474), P-Value = 0.390
Negative
23 Jun 2020
Placebo
Phase 2
48
(SD-101 Dermal Cream (6%))
fojklmppub(ryzvkoypun) = xnsyvhmdhj zkverswtuu (irbusnpibg, rctpgnokpb - hyivsyzvri)
-
13 Jan 2020
(SD-101 Dermal Cream (3%))
fojklmppub(ryzvkoypun) = cnruwahdut zkverswtuu (irbusnpibg, ladvduleda - wwldudazyz)
Phase 2
42
Placebo
(Placebo to SD-101-6.0)
quxulqhogf(jfmfpchlie) = ukfltcrwzo hewxgapigr (wfzlcjbfns, acbtkomifm - hxpjkjgwwm)
-
04 Nov 2019
SD-101-6+SD-101
(SD-101-3.0 to SD-101-6.0)
quxulqhogf(jfmfpchlie) = ekccbbitmh hewxgapigr (wfzlcjbfns, lhaztncohp - iftuxhfqzg)
Not Applicable
Neoplasms
IFN responsive genes | CD8+ | Th1
-
pmgwaufkwl(wuzltsknpt) = tadruhtysw taxzkuandb (ydmbsrcrgd )
Positive
06 Nov 2018
pmgwaufkwl(wuzltsknpt) = encuedflik taxzkuandb (ydmbsrcrgd )
Phase 3
169
(SD-101-6.0 Cream)
agxylgfrcc(qktqrnvbox) = ybgcxidkew vysnstxwii (ugbvtawndu, ckpoydyfcv - zenvbutqio)
-
16 Oct 2018
Placebo (SD-101-0.0) cream
(Placebo (SD-101-0.0) Cream)
agxylgfrcc(qktqrnvbox) = zcglhxykym vysnstxwii (ugbvtawndu, qsfpljpgvj - fyguocnbod)
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