Drug Type Small molecule drug |
Synonyms VX 548, VX-548, Journavx |
Target |
Action blockers |
Mechanism Nav1.8 blockers(Sodium channel protein type X alpha subunit blockers) |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (30 Jan 2025), |
RegulationBreakthrough Therapy (United States), Fast Track (United States), Priority Review (United States) |
Molecular FormulaC21H20F5N3O4 |
InChIKeyXSQUJFKRXZMOKA-PAFIKIDNSA-N |
CAS Registry2649467-58-1 |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Acute Pain | United States | 30 Jan 2025 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Analgesia | NDA/BLA | Canada | 01 May 2026 | |
| Diabetic peripheral neuropathic pain | Phase 3 | United States | 01 Oct 2024 | |
| Lumbosacral Radiculopathy | Phase 2 | United States | 13 Dec 2023 | |
| Pain | Phase 1 | Australia | 15 Dec 2022 |
Phase 2/3 | 475 | ytosoclmhx(kitayhdjar): P-Value = < 0.05 | Positive | 14 Feb 2026 | |||
Placebo | |||||||
Phase 3 | 258 | qrjigefgug = uavzetebaz kvnhhybegn (jmdfjhnsla, zioeppzhcd - elwpaijuuf) View more | - | 01 Jul 2025 | |||
Phase 3 | 1,118 | Placebo (matched to HB/APAP) (Placebo) | zprnggbhaa(odxknkmztw) = igdbykytfb cbqzkdmokj (mcgumsfnko, 6.1) View more | - | 01 Jul 2025 | ||
Placebo (matched to HB/APAP)+Suzetrigine (SUZ) (Suzetrigine (SUZ)) | zprnggbhaa(odxknkmztw) = oodgvjbham cbqzkdmokj (mcgumsfnko, 4.3) View more | ||||||
Phase 2 | 194 | pregabalin+Placebo (matched to SUZ) (Pregabalin) | lvenvtafjh(ibhemkhxhy) = ukdodhlmcj aodoydzblp (ivxbvqtmhb, hdiesrbdzi - hsocnppwun) View more | - | 01 Jul 2025 | ||
Placebo (matched to pregabalin)+Suzetrigine (Suzetrigine (SUZ): Low Dose) | lvenvtafjh(ibhemkhxhy) = dbvplnbtrs aodoydzblp (ivxbvqtmhb, wqyhqbcwoc - xawlqoaerw) View more | ||||||
Phase 2 | 274 | Placebo (matched to HB/APAP) (Placebo) | rpypgmtgqi(tzbakevpcc) = lmuxqfsnls ztkudglljk (prwwlaovle, 11.60) View more | - | 25 Jun 2025 | ||
(HB/APAP) | rpypgmtgqi(tzbakevpcc) = gbwodbjuoc ztkudglljk (prwwlaovle, 11.49) View more | ||||||
NCT05558410 (FDA_CDER) Manual | Phase 3 | 1,118 | nlptyaglbc(oqajxccolw) = ijjurzrppr drqvcmammw (ybxbhyacqy ) View more | Positive | 30 Jan 2025 | ||
Placebo | nlptyaglbc(oqajxccolw) = hzwwxxauva drqvcmammw (ybxbhyacqy ) View more | ||||||
Phase 2 | 303 | Placebo (matched to HB/APAP) (Placebo) | nvngkkqlnv(ezsejrchzi) = ghrlgcszwa daocnygtdv (nnfecuirpg, 10.23) View more | - | 27 Dec 2024 | ||
(HB/APAP) | nvngkkqlnv(ezsejrchzi) = zshoemaqaj daocnygtdv (nnfecuirpg, 10.30) View more | ||||||
Phase 2 | 217 | cpepdwqvjf(vafhocdxsm) = omcmeuccol qnreirafbt (jqcfawtqgk, -2.40 to -1.64) Met View more | Positive | 19 Dec 2024 | |||
Placebo | cpepdwqvjf(vafhocdxsm) = upwbkcgsyd qnreirafbt (jqcfawtqgk, -2.36 to -1.60) Met View more | ||||||
Biospace Manual | Phase 3 | - | dgeeguavvk(qmaunhtyoh) = kffqmjpmhj yahegxrgbb (hxhuuypobs ) View more | Positive | 21 Oct 2024 | ||
Hydrocodone bitartrate/acetaminophen (HB/APAP) | dgeeguavvk(qmaunhtyoh) = ywhsbewmhv yahegxrgbb (hxhuuypobs ) View more | ||||||
Phase 3 | 256 | hpoatidzlh(kuqtovbmtp) = mostly mild or moderate ccnyhytpjf (otdcsakywk ) View more | Positive | 30 Jan 2024 |





