Solriamfetol Hydrochloride Drug Due Diligence Report 2026

This Solriamfetol Hydrochloride Drug Asset Due Diligence Report was built with PatSnap Life Sciences MCP workflows. Drug & Asset MCP establishes identity, ownership and stage; Clinical Trials MCP checks design, endpoints and readouts; Company & Deal Intelligence MCP reconstructs transaction precedent. Explore the MCP servers used in this report.

Decision date: 15 July 2026. Currency fields are presented in US$ millions as returned by the deal dataset. This is a screening memorandum, not legal, medical, patent or investment advice.

Approved

Highest phase

Registered trials

Result records

Matched deals

Executive recommendation: GO

Decision memo

Advance diligence: development maturity and available evidence support continued investment, subject to indication-specific safety, IP, and commercial gates.

The central underwriting question is whether Solriamfetol Hydrochloride can convert its Small molecule drug profile and 5-HT1A receptor x DAT x NET x TAAR1 biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Solriamfetol Hydrochloride (query alias: solriamfetol)
Modality / target	Small molecule drug; 5-HT1A receptor x DAT x NET x TAAR1; 5-HT1A receptor agonists, DAT antagonists, NET inhibitors
Highest global status	Approved
Originator	SK Biopharmaceuticals Co., Ltd.
Active developers	Axsome Therapeutics, Inc., Axsome Malta Ltd., Jazz Pharmaceuticals, Inc.

The MCP disease footprint includes Excessive Daytime Sleepiness, Narcolepsy, Sleep Apnea, Obstructive. The highest-phase flag is a useful orientation point, but the licensing case depends on indication-level evidence and rights, not the global label alone.

2. Clinical program: design and endpoint audit

Registry	Phase	Status	Enrollment	Lead primary endpoint
NCT06568367	Phase 3	Recruiting	520	Change from Baseline to Week 12 in the mean sleep latency time as measured by the Maintenance of Wakefulness Test (MWT).
NCT07484217	Phase 3	Recruiting	508	Time from randomization to relapse of depressive symptoms
NCT06878976	Phase 3	Enrolling by invitation	300	Long-term Safety

The trial set should be diligenced for randomization, comparator relevance, endpoint hierarchy, analysis population, multiplicity, geographic mix and readout timing. For early-stage studies, safety and dose selection can be as decision-critical as response rate.

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3. Clinical readouts: what is known

Solriamfetol for Excessive Sleepiness in Early-Morning Shift Work Disorder

Phase 3; n=78; evaluation: Positive. Reported fields: CGIC: OR = 3.7(95.0% CI, 1.3 - 10.4); CGIC: OR = 3.7(95.0% CI, 1.3 - 10.4)

Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study (SHARP): a 5-Week Double-blind, Placebo-controlled, Randomized, Crossover, Multicenter Study of Solriamfetol in Improving Cognitive Function in Participants With Excessive Daytime Sleepiness Associated With Obstructive Sleep Apnea Plus Impaired Cognitive Function

Phase 4; n=59; evaluation: not stated. Reported fields: Change From Baseline in the Average of the DSST RBANS Scores at the End of Each Double-blind Treatment Period(Least Squares Mean) = 4.75 score on a scale (Standard Error, 0.646); Change From Baseline in the Average of the DSST RBANS Scores at the End of Each Double-blind Treatment Period(Least Squares Mean) = 6.49 score on a scale (Standard Error, 0.650); Change From Baseline in the Average of the DSST RBANS Scores at the End of Each Double-blind Treatment Period(Least Squares Mean): P-Value = 0.009

Solriamfetol improves daily fatigue symptoms in adults with myalgic encephalomyelitis/chronic fatigue syndrome after 8 weeks of treatment

Phase 4; n=38; evaluation: Positive. Reported fields: Behavioral Rating Inventory of Executive Function for Adults (BRIEF-A)(Week 8): P-Value = 0.012; Behavioral Rating Inventory of Executive Function for Adults (BRIEF-A)(Week 8): P-Value = 0.012

These fields are structured evidence signals, not a substitute for statistical review. The next diligence pass should reconcile denominators, confidence intervals, follow-up, censoring, dose cohorts and treatment-emergent toxicity against the original abstract, registry and protocol.

4. Market and competitive position

Solriamfetol Hydrochloride addresses Excessive Daytime Sleepiness, Narcolepsy, Sleep Apnea, Obstructive. Commercial attractiveness rests on addressable biomarker-positive patients, treatment-line placement, duration, administration burden, pricing and displacement of entrenched standards. The modality—Small molecule drug—must demonstrate a benefit large enough to offset class-specific safety and operational costs.

The strongest market-validation signal in this screen is partner behavior: 5 matched transaction record(s) indicate that sophisticated counterparties have assigned strategic value to the asset or its rights. That does not establish net present value; probability of success, remaining R&D spend, royalties, cost sharing and territorial scope still need modeling.

5. Transaction precedent and economics

Date	Transaction	Phase at deal	Disclosed economics
2025-02-24	Pharmanovia announces exclusive distribution agreement with Er-Kim for Sunosi® in Eastern Europe	Approved	Financial terms not disclosed
2023-02-22	Pharmanovia will develop and market Axsome's Sunosi for excessive daytime sleepiness (EDS) caused by narcolepsy or obstructive sleep apnea (OSA) in Europe and MENA.	Approved	US$66.0M upfront; US$101.0M milestones; US$167.0M stated total
	Jazz Pharmaceuticals Announces Agreement to Divest Sunosi® (solriamfetol) to Axsome Therapeutics	Approved	US$53.0M upfront; US$53.0M stated total

Headline values are not directly comparable. Diligence should normalize upfront cash, equity, development and sales milestones, tiered royalties, opt-in mechanics, cost sharing, change-of-control clauses and geography.

6. IP and freedom-to-operate screen

The milestone feed surfaced a patent-application signal described as “Process to obtain solriamfetol hydrochloride”. The milestone feed surfaced a patent-application signal described as “Solriamfetol for improving cognitive health in apnea patients”. The milestone feed surfaced a patent-application signal described as “Use of solriamfetol for the treatment of orphan diseases”.

The claim chart should separately test composition or sequence coverage, formulation and dosing, indication and biomarker claims, combinations, manufacturing know-how, prosecution history, term extensions and third-party blocking rights. Confirm that licensed patents, data and know-how track every granted territory and field.

7. Principal risks and diligence gates

Therapeutic index across KRAS/BRAF mutation subgroups
On-target toxicity and adaptive MAPK resistance
Lack of matched efficacy results in the current MCP result set

Cross-functional diligence should also test CMC comparability, supply chain, pharmacovigilance, regulatory correspondence, data integrity, investigator concentration, partner obligations and change-of-control restrictions.

8. Final go/no-go memorandum

GO