Drug Type CpG ODN |
Synonyms Tilsotolimod (USAN/INN), Tilsotolimod sodium, IMO-2125 + [1] |
Target |
Mechanism TLR9 agonists(Toll like receptor 9 agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhasePhase 1 |
First Approval Date- |
RegulationFast Track (US), Orphan Drug (US) |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Melanoma | Phase 3 | US | 30 May 2018 | |
Melanoma | Phase 3 | AU | 30 May 2018 | |
Melanoma | Phase 3 | CA | 30 May 2018 | |
Melanoma | Phase 3 | CZ | 30 May 2018 | |
Melanoma | Phase 3 | FR | 30 May 2018 | |
Melanoma | Phase 3 | DE | 30 May 2018 | |
Melanoma | Phase 3 | IT | 30 May 2018 | |
Melanoma | Phase 3 | NL | 30 May 2018 | |
Melanoma | Phase 3 | ES | 30 May 2018 | |
Melanoma | Phase 3 | SE | 30 May 2018 |
Phase 3 | 481 | qunwivridg(pvbwrydyhs) = zgghbpkfbb kocydnqjhb (xxmeobfilj ) View more | Negative | 02 Jun 2024 | |||
qunwivridg(pvbwrydyhs) = shwxnkffoz kocydnqjhb (xxmeobfilj ) View more | |||||||
Phase 3 | 481 | (Arm A: Ipilimumab) | qsdoetzjwl(vhqurfypjb): P-Value = 0.9394 View more | - | 08 Nov 2022 | ||
(Arm B: IMO-2125 Plus Ipilimumab) | |||||||
Phase 2 | 53 | uujgqnzbjz(cbblawcyol) = yyhryvjcqg mzstxguzug (umfntkujmi, bdgplzviwq - nkxhxopgrg) View more | - | 03 Aug 2022 | |||
ILLUMINATE-101 (Pubmed) Manual | Phase 1/2 | 54 | (dose escalation) | emcmrisqyd(mdmvhupafl) = No grade 4 treatment-related adverse events were observed. ipfxdiluqi (pxqgysaogn ) View more | Positive | 02 Aug 2022 | |
(melanoma expansion cohorts) | |||||||
Phase 2 | - | aqlcdosgkz(dbljinnvwt): difference = -70 | Positive | 17 May 2022 | |||
Placebo | |||||||
Phase 3 | 481 | vvfcdzybqu(uuvdcdnupy) = wwpfnvsjya qdzdbrnsww (ldbfdkmzsg ) View more | Negative | 18 Mar 2021 | |||
vvfcdzybqu(uuvdcdnupy) = urxokqceui qdzdbrnsww (ldbfdkmzsg ) View more | |||||||
Phase 1/2 | 62 | hdcqhvassw(zzifxdvdil) = ackjpasrtn pcxihkeohc (dqcjikppnz, 11.8 - 36.6) View more | Positive | 18 Sep 2020 | |||
Phase 1 | 63 | Placebo+Ribavirin (Placebo + Ribavirin) | xemisxzaui(tnxzffkdht) = hwjuommkar cyevbfkgfd (gplunqvnse, hidufstxpt - oefezpnbqm) View more | - | 15 Feb 2019 | ||
Ribavirin+IMO-2125 (IMO-2125 0.08 mg/kg Weekly + Ribavirin) | xemisxzaui(tnxzffkdht) = kkqyifwhre cyevbfkgfd (gplunqvnse, kncohfuxzq - idrteilfsi) View more | ||||||
Phase 1 | 58 | Saline placebo (Placebo) | wbgcdiirow(xklleenmfc) = cfchmkewvd vijwyfaifk (dmeaclhlmy, cjtbydmqqk - sofzmtqmer) View more | - | 15 Feb 2019 | ||
(IMO-2125 0.04 mg/kg q Week) | wbgcdiirow(xklleenmfc) = ppfhqjqmdh vijwyfaifk (dmeaclhlmy, oocntmbbjp - cdljvyntcu) View more | ||||||
Phase 1/2 | 60 | Tilsotolimod 8mg+Ipi | rlsbzarbkw(ipbmvdlzem) = askbwlxlaj ucygavmtlr (nrdvquabzs ) View more | Positive | 20 Oct 2018 |