Suzetrigine

Non-opioid analgesic drug From Wikipedia, the free encyclopedia

Suzetrigine

Suzetrigine, sold under the brand name Journavx, is a medication used for pain management.[1][2] It is a non-opioid, small-molecule analgesic that works as a selective inhibitor of Nav1.8-dependent pain-signaling pathways in the peripheral nervous system.[3][4] It is not addictive. Suzetrigine is taken by mouth.[1]

Quick Facts Clinical data, Pronunciation ...
Suzetrigine
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Clinical data
Pronunciation/suˈzɛtrɪn/
soo-ZE-tri-jeen
Trade namesJournavx
Other namesVX-548
AHFS/Drugs.comJournavx
License data
Routes of
administration
By mouth
Drug classNav1.8 sodium channel blocker; Analgesic
ATC code
  • None
Legal status
Legal status
Identifiers
  • 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
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
ChEMBL
Chemical and physical data
FormulaC21H20F5N3O4
Molar mass473.400 g·mol−1
3D model (JSmol)
  • COc1c([C@H]2[C@H](C(=O)Nc3ccnc(C(N)=O)c3)O[C@@](C)(C(F)(F)F)[C@H]2C)ccc(F)c1F
  • InChI=1S/C21H20F5N3O4/c1-9-14(11-4-5-12(22)15(23)16(11)32-3)17(33-20(9,2)21(24,25)26)19(31)29-10-6-7-28-13(8-10)18(27)30/h4-9,14,17H,1-3H3,(H2,27,30)(H,28,29,31)/t9-,14-,17-,20-/m0/s1
  • Key:XSQUJFKRXZMOKA-PAFIKIDNSA-N
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The most common adverse reactions include itching, muscle spasms, increased blood level of creatine kinase, and rash.[1][2]

Suzetrigine was developed by Vertex Pharmaceuticals.[5] It was approved for medical use in the United States in January 2025.[2][6] Suzetrigine is the first medication to be approved by the US Food and Drug Administration (FDA) in this class of medicines.[2]

Medical uses

Suzetrigine is indicated for the treatment of moderate to severe acute pain in adults.[1][2]

Efficacy

In clinical studies conducted through 2024, suzetrigine reduced pain typically from seven to four on the standard numerical scale used to rate pain.[7][8] This pain relief matched a combination of hydrocodone and paracetamol (acetaminophen) (5 mg of hydrocodone bitartrate and 325 mg of acetaminophen).[8][9]

Suzetrigine suppresses pain at the same level as opioids, but without the risks of addiction, sedation, or overdose.[10]

The efficacy of suzetrigine was evaluated in two randomized, double-blind, placebo- and active-controlled trials of acute surgical pain, one following abdominoplasty and the other following bunionectomy.[2] Both trials found that suzetrigine reduced pain more effectively than placebo.[2]

Contraindications

Concomitant use of suzetrigine with strong CYP3A inhibitors is contraindicated.[1][2]

Adverse effects

Common adverse effects of suzetrigine may include itching, rash, muscle spasms, and increased levels of creatine kinase.[2] Mild side effects may include nausea, constipation, headache, and dizziness.[7][8] As of 2024, long-term safety and side effects remain undetermined.[8]

In preliminary research, suzetrigine had no serious neurological, behavioral, or cardiovascular effects.[3]

Interactions

Consuming grapefruit while using suzetrigine may cause an adverse grapefruit–drug interaction.[1][2]

Mechanism of action

Suzetrigine operates on peripheral nerves, avoiding the addictive potential of opioids which affect the central nervous system.[3][4][7] Unlike opioid medications, which reduce pain signals in the brain, suzetrigine works by closing sodium channels in peripheral nerves, inhibiting pain-signaling nerves from transmitting painful sensations to the brain.[3][4][7]

In pharmacological studies, suzetrigine selectively inhibited Nav1.8 channels, but not other voltage-gated sodium channels, and bound to a unique site on these sodium channels with a novel allosteric mechanism, by binding to the channel's second voltage sensing domain, thereby stabilizing the closed state, causing tonic inhibition. It exerts its action on dorsal root ganglion.[3]

History

Vertex Pharmaceuticals announced in January 2024 that suzetrigine had successfully met several endpoints in its Phase III clinical trials.[5] The company announced in July 2024 that the FDA had accepted a new drug application for suzetrigine.[11] The FDA granted the application for suzetrigine priority review, fast track, and breakthrough therapy designations.[2][11] In January 2025, the FDA granted approval of Journavx to Vertex Pharmaceuticals, thereby becoming the first non-opioid pain medication to be approved by the FDA in two decades.[2][10]

Society and culture

Suzetrigine was approved for medical use in the United States in January 2025.[2]

Names

Suzetrigine is the international nonproprietary name.[12]

Suzetrigine is sold under the brand name Journavx.[1][2]

References

Further reading

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