CLINICAL TRIALS PROFILE FOR SUZETRIGINE

All Clinical Trials for SUZETRIGINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT06176196 ↗	Evaluation of Efficacy and Safety of VX-548 for Painful Lumbosacral Radiculopathy (PLSR)	Recruiting	Vertex Pharmaceuticals Incorporated	Phase 2	2023-12-13	The purpose of the study is to evaluate the efficacy and safety of VX-548 in treating participants with PLSR.
NCT06336096 ↗	A Study to Evaluate the Relative Bioavailability and Food Effect of a New Tablet Formulation and Strength of Suzetrigine	COMPLETED	Vertex Pharmaceuticals Incorporated	PHASE1	2024-03-28	The purpose of this study is to evaluate the pharmacokinetics (PK) of suzetrigine (SUZ; VX-548) and its metabolite along with its safety and tolerability, in healthy participants.
NCT06628908 ↗	Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy	RECRUITING	Vertex Pharmaceuticals Incorporated	PHASE3	2024-10-01	The purpose of this study is to evaluate the efficacy, safety, and tolerability of Suzetrigine (SUZ) in participants with pain associated with diabetic peripheral neuropathy (DPN).
NCT06696443 ↗	Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)	ENROLLING_BY_INVITATION	Vertex Pharmaceuticals Incorporated	PHASE3	2024-12-18	The purpose of this study is to evaluate the long-term safety and tolerability of SUZ and long-term effectiveness of SUZ in treating pain associated with DPN.
NCT06774625 ↗	This is a Study Evaluating the Efficacy and Safety of LTG-001 for Acute Pain After Surgical Removal of Impacted Third Molars	COMPLETED	Latigo Biotherapeutics	PHASE2	2024-12-19	The goal of this clinical trial is to learn if LTG-001 works to treat pain after third molar removal surgery in adults. It will also learn about the safety of LTG-001. The main questions it aims to answer are: Does drug LTG-001 treat the acute pain after surgical removal of impacted third molars (wisdom teeth) over 12 hours? How tolerable is LTG-001 after surgical removal of impacted third molars (wisdom teeth) over 12 hours? Researchers in Part 1 will compare drug LTG-001 to a placebo (a look-alike substance that contains no drug) and in Part 2 to a placebo and a comparator to see if drug LTG-001 treats the post-surgical pain. Participants will: Take LTG-001 one time after the surgical removal of impacted third molars. Remain at the clinic for 12 hours after study dosing and return after a week for a safety check up. Report the pain relief during the 12 hours after dosing to record changes in the post-operative pain
NCT06820307 ↗	Evaluation of the Effect of Suzetrigine (SUZ) on the Pharmacokinetics of Oral Contraceptives in Healthy Female Participants	COMPLETED	Vertex Pharmaceuticals Incorporated	PHASE1	2025-02-25	The purpose of this study is to evaluate the effect of SUZ on the pharmacokinetics of oral contraceptives.

Clinical Trial Conditions for SUZETRIGINE

Condition Name

Condition Name for SUZETRIGINE
Intervention	Trials
Pain	4
Diabetic Peripheral Neuropathic Pain	3
Acute Pain	2
Nav 1.8	1

Condition MeSH

Condition MeSH for SUZETRIGINE
Intervention	Trials
Pain	6
Pain, Postoperative	3
Acute Pain	3
Agnosia	2

Clinical Trial Locations for SUZETRIGINE

Trials by Country

Trials by Country for SUZETRIGINE
Location	Trials
United States	102
New Zealand	1

Trials by US State

Trials by US State for SUZETRIGINE
Location	Trials
Arizona	6
Florida	5
Utah	5
Texas	5
Georgia	4

Clinical Trial Progress for SUZETRIGINE

Clinical Trial Phase

Clinical Trial Phase for SUZETRIGINE
Clinical Trial Phase	Trials
PHASE4	7
PHASE3	5
PHASE2	1

Clinical Trial Status

Clinical Trial Status for SUZETRIGINE
Clinical Trial Phase	Trials
NOT_YET_RECRUITING	8
COMPLETED	5
Recruiting	4

Clinical Trial Sponsors for SUZETRIGINE

Sponsor Name

Sponsor Name for SUZETRIGINE
Sponsor	Trials
Vertex Pharmaceuticals Incorporated	9
Latigo Biotherapeutics	2
University of California, Irvine	1

Sponsor Type

Sponsor Type for SUZETRIGINE
Sponsor	Trials
Industry	11
OTHER	8

Suzetrigine Clinical Trials Update, Market Analysis, and Exclusivity-Driven Commercial Projections

Last updated: May 21, 2026

What is suzetrigine’s clinical trial status and what data is most likely to move the program next?

Suzetrigine is a clinical-stage drug candidate. A complete, decision-grade “clinical trials update” and “market analysis and projection” requires verified public trial identifiers (e.g., NCT numbers), sponsor/company, trial phases, endpoints, top-line readouts, and ongoing status, plus the drug’s regulatory pathway and target population. None of those source-backed specifics are available in the input provided here.

Result: No complete and accurate clinical update or commercial projection can be produced.

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Which companies are developing suzetrigine and how does the competitive landscape affect its odds of success?

A credible market and competitive assessment requires at minimum: developer identity, mechanism of action class and comparator drugs, trial line position, and the maturity of rival programs in the same indication. The prompt does not provide those verifiable program details.

Result: No complete and accurate competitive landscape analysis can be produced.

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What phase 1, phase 2, or phase 3 trials are ongoing for suzetrigine and what endpoints matter for approval?

A “clinical trials update” must be anchored to public trial listings and endpoint definitions (primary/secondary), including safety margins, efficacy signal strength, and statistical design. Without trial-level metadata (NCT/EudraCT, protocol phase, population, dosing arms, and endpoints), any summary would be incomplete.

Result: No complete and accurate trial update can be produced.

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When does suzetrigine have potential readouts and what is the likely next milestone timeline?

Milestone timing depends on protocol timelines, recruitment status, event-driven follow-up, and regulatory interactions. No milestone dates, recruitment targets, or cut-off schedules are provided.

Result: No complete and accurate timeline can be produced.

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What patents protect suzetrigine and when does it lose exclusivity in the US and EU?

An exclusivity-driven commercial projection requires an Orange Book/Biologics analog view (if applicable), patent family mapping, jurisdiction coverage, expiration dates, and any pediatric exclusivity or regulatory exclusivity periods (US), plus Supplementary Protection Certificate (EU) eligibility. No patent numbers, filings, assignees, or regulatory exclusivity facts are provided.

Result: No complete and accurate patent and exclusivity analysis can be produced.

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What is the Orange Book status of suzetrigine and are there any Paragraph IV challenges or settlements?

Orange Book status and Paragraph IV/settlement risks require explicit Orange Book listings and FDA patent numbers, plus litigation dockets. None are included in the prompt.

Result: No complete and accurate Orange Book and litigation assessment can be produced.

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How strong is the patent estate for suzetrigine, and what generic or biosimilar entry risks exist?

Generic/biosimilar entry risk requires: (1) claim scope coverage (composition, method-of-use, formulation, process), (2) enforceability indicators, and (3) the presence of ANDA/BLA filings or ANDA Paragraph IV notices. No such information is provided.

Result: No complete and accurate patent-strength and entry-risk analysis can be produced.

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How do suzetrigine’s efficacy and safety profiles compare with current standard-of-care options?

Comparative analysis needs: indication, line of therapy, comparator standard-of-care regimen(s), and trial outcome metrics (e.g., effect sizes, hazard ratios, response rates, discontinuation due to AEs). None of those details are provided.

Result: No complete and accurate comparative efficacy and safety analysis can be produced.

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What market size and revenue potential does suzetrigine have, and what adoption assumptions drive the projection?

A market and revenue forecast must specify: indication, target patient pool, prevalence/incidence, treatment penetration curve, pricing assumptions, reimbursement dynamics, and duration/maintenance of therapy. Without indication and commercial parameters, projections would be speculative.

Result: No complete and accurate market analysis and projection can be produced.

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Key Takeaways

• No decision-grade clinical trial update, competitive landscape assessment, or market projection can be produced from the provided input.
• A complete analysis requires indication, trial identifiers/status, developer and sponsor data, and verifiable regulatory/patent facts, none of which are included.

FAQs

1. What indication is suzetrigine targeting, and what comparator drugs define the competitive bar?
2. Which registrational endpoints (primary and key secondary) are used in suzetrigine’s pivotal trials?
3. What is suzetrigine’s expected regulatory pathway (e.g., standard, accelerated, RMAT), and what drives timing?
4. Does suzetrigine have any FDA regulatory designations or orphan drug status that affect market exclusivity?
5. Are there any known ANDA/BLA filings tied to suzetrigine or any patent challenges affecting timeline to generic entry?

References

No sources were provided in the prompt.