Suzetrigine

Suzetrigine
Clinical data
Other names	VX-548
Legal status
Legal status	Investigational;
Identifiers
	IUPAC name 4-[[(2R,3S,4S,5R)-3-(3,4-Difluoro-2-methoxyphenyl)-4,5-dimethyl-5-(trifluoromethyl)oxolane-2-carbonyl]amino]pyridine-2-carboxamide;
CAS Number	2649467-58-1;
PubChem CID	156445116;
UNII	LOG73M21H5;
KEGG	D12860;
Chemical and physical data
Formula	C21H20F5N3O4
Molar mass	473.400 g·mol−1
3D model (JSmol)	Interactive image;
	SMILES CC1C(C(OC1(C)C(F)(F)F)C(=O)NC2=CC(=NC=C2)C(=O)N)C3=C(C(=C(C=C3)F)F)OC;

Suzetrigine (VX-548) is a non-opioid, small-molecule analgesic that works as a selective inhibitor of Nav1.8-dependant pain signaling pathways in the peripheral nervous system.^[1] It is being developed by Vertex Pharmaceuticals and has completed two Phase III trials.^[2]

Vertex announced in January 2024 that VX-548 successfully met several endpoints in its Phase III trials. The drug relieved moderate to severe post-surgical pain. Vertex hopes the drug, which operates on peripheral nerves, will avoid the addictive potential of opioids.^[2]^[3]

Vertex plans to submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA) by mid-2024 seeking a broad label for moderate-to-severe acute pain. VX-548 has already secured FDA Breakthrough Therapy and Fast Track designations for acute pain.^[2]

Vertex also plans to seek a broad label for peripheral neuropathic pain, citing positive Phase 2 results in painful diabetic peripheral neuropathy (DPN).^[2]

References[edit]

^ Jones, Jim; Correll, Darin J.; Lechner, Sandra M.; Jazic, Ina; Miao, Xiaopeng; Shaw, David; Simard, Christopher; Osteen, Jeremiah D.; Hare, Brian; Beaton, Alina; Bertoch, Todd; Buvanendran, Asokumar; Habib, Ashraf S.; Pizzi, Lois J.; Pollak, Richard A.; Weiner, Scott G.; Bozic, Carmen; Negulescu, Paul; White, Paul F. (3 August 2023). "Selective Inhibition of NaV1.8 with VX-548 for Acute Pain". The New England Journal of Medicine. 389 (5): 393–405. doi:10.1056/NEJMoa2209870. ISSN 1533-4406. PMID 37530822. S2CID 260377748.
^ ^a ^b ^c ^d Vertex Pharmaceuticals Incorporated Vertex Announces Positive Results From the VX-548 Phase 3 Program for the Treatment of Moderate-to-Severe Acute Pain. Press Release, Jan 30, 2024.
^ Kolata, Gina (30 January 2024). "Experimental Drug Cuts Off Pain at the Source, Company Says". The New York Times. Retrieved 31 January 2024.

[1] Jones, Jim; Correll, Darin J.; Lechner, Sandra M.; Jazic, Ina; Miao, Xiaopeng; Shaw, David; Simard, Christopher; Osteen, Jeremiah D.; Hare, Brian; Beaton, Alina; Bertoch, Todd; Buvanendran, Asokumar; Habib, Ashraf S.; Pizzi, Lois J.; Pollak, Richard A.; Weiner, Scott G.; Bozic, Carmen; Negulescu, Paul; White, Paul F. (3 August 2023). "Selective Inhibition of NaV1.8 with VX-548 for Acute Pain". The New England Journal of Medicine. 389 (5): 393–405. doi:10.1056/NEJMoa2209870. ISSN 1533-4406. PMID 37530822. S2CID 260377748.

[Vertexrelease-2] Vertex Pharmaceuticals Incorporated Vertex Announces Positive Results From the VX-548 Phase 3 Program for the Treatment of Moderate-to-Severe Acute Pain. Press Release, Jan 30, 2024.

[3] Kolata, Gina (30 January 2024). "Experimental Drug Cuts Off Pain at the Source, Company Says". The New York Times. Retrieved 31 January 2024.

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