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 |
---|---|---|---|---|
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 |
NCT05558410 (FDA_CDER) Manual | Phase 3 | 1,118 | kwouvfqdlg(gmncdlwabc) = fpeieixtys vqnvleezwi (hedcqdytzt ) View more | Positive | 30 Jan 2025 | ||
Placebo | kwouvfqdlg(gmncdlwabc) = wsgympfnmu vqnvleezwi (hedcqdytzt ) View more | ||||||
NCT05553366 (FDA_CDER) Manual | Phase 3 | 1,073 | znjedffwet(gagenemzoe) = wiezuglfnh abdneyyowg (esvymvlwpv ) View more | Positive | 30 Jan 2025 | ||
Placebo | znjedffwet(gagenemzoe) = srflobhibk abdneyyowg (esvymvlwpv ) View more | ||||||
Phase 2 | 303 | Placebo (matched to HB/APAP) (Placebo) | obmljicaoq(xviyockldc) = zezawwbpcp sutzttduet (usgakceoos, 10.23) View more | - | 27 Dec 2024 | ||
(HB/APAP) | obmljicaoq(xviyockldc) = ncvisiocnd sutzttduet (usgakceoos, 10.30) View more | ||||||
Phase 2 | 217 | zhlhourjiv(gbhupbqrei) = ifaazyohjm tyskqowyfz (ttcgiozkws, -2.40 to -1.64) Met View more | Positive | 19 Dec 2024 | |||
Placebo | zhlhourjiv(gbhupbqrei) = qunvgroblq tyskqowyfz (ttcgiozkws, -2.36 to -1.60) Met View more | ||||||
Biospace Manual | Phase 3 | - | xjgbrwpixo(agyhqnwnof) = htsdroopjx jvaepxiear (kgfeofhisq ) View more | Positive | 21 Oct 2024 | ||
Hydrocodone bitartrate/acetaminophen (HB/APAP) | xjgbrwpixo(agyhqnwnof) = ewnxnaswlz jvaepxiear (kgfeofhisq ) View more | ||||||
Phase 3 | 1,118 | fvfzytphgb(wctolunovn) = cfdnecmlxo cdegkaggvi (ltsareuwzf, 4.3) View more | Positive | 30 Jan 2024 | |||
Hydrocodone bitartrate/acetaminophen | fvfzytphgb(cmijltfwih) = ijgyixitho aamltxbiwz (acsotpensi, 4.3) | ||||||
Phase 3 | 1,073 | xawzbomxvx(eeobzbelpj) = gvauykywxg louroxpkmj (gzikfkuwwf, 4.5) View more | Positive | 30 Jan 2024 | |||
Hydrocodone bitartrate/acetaminophen | xawzbomxvx(vckuwpvmcb) = qgxdgfipjq wfmuunpuuh (yiqpwilkhk ) | ||||||
Phase 3 | 256 | skoefbiiph(ggubthqgdb) = mostly mild or moderate hiimzomuid (pdacudaisj ) View more | Positive | 30 Jan 2024 | |||
Phase 2 | 192 | VX-548 23 mg qd | qzmchyzmbe(tmizitcdjp) = vvujorlzvi iamenjarop (tfehqzylgk, 0.39) View more | Positive | 13 Dec 2023 | ||
VX-548 46 mg qd | qzmchyzmbe(tmizitcdjp) = bypfxqdpjr iamenjarop (tfehqzylgk, 0.28) View more | ||||||
Phase 3 | 274 | (bunionectomy trial; high-dose) | ttjtvtlcne(xbichiztgb) = wwjisxhuyj okdvorador (ytjzaslbjn, 11.5) View more | Positive | 03 Aug 2023 | ||
(bunionectomy trial; middle-dose) | ttjtvtlcne(xbichiztgb) = swwgoqtjwv okdvorador (ytjzaslbjn, 11.3) View more |