Solriamfetol hydrochloride is under clinical development by SK Biopharmaceuticals and currently in the Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Solriamfetol hydrochloride’s likelihood of approval (LoA) and phase transition for Attention Deficit Hyperactivity Disorder (ADHD) took place on 14 Sep 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Solriamfetol hydrochloride Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Solriamfetol hydrochloride overview

Solriamfetol hydrochloride (Sunosi) was a phenylalanine derivative, acts as an wake-promoting agent. It is formulated as film coated tablets for oral route of administration. Sunosi is indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA), and to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive  sleep  apnoea (OSA)  whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP).

Solriamfetol hydrochloride (SKL-N05/JZP-110/ADX-N05) is under development for the treatment of pediatric subjects with narcolepsy, excessive sleep in idiopathic Parkinson’s disease and attention deficit hyperactivity disorder (ADHD). It is administered orally. The drug candidate is an optically pure phenylalanine derivative. The adrenergic agent was also under development for the treatment of drug addiction and major depressive disorder.

SK Biopharmaceuticals overview

SK Biopharmaceuticals, a subsidiary of SK Inc, is a researcher and developer of drugs. The company develops and markets drugs for the treatment of the central nervous system. Its product pipeline includes Cenobamate, Carisbamate, Relenopride, SKL24741, SKL20540, SKL27969, SKL13865 and SKL-PSY. SK Biopharmaceuticals offers research and development; biological studies, preclinical studies, lead compound development, and phase development services. The company provides the development of next-generation drugs that maintain efficacy and minimize side effects and toxicity by harnessing life science technologies in new drug and development programs. It has developed drug candidates in the area of CNS such as epilepsy and GI with chronic constipation and constipation dominant irritable bowel syndrome. SK Biopharmaceuticals is headquartered in Seongnam, South Korea.

Quick View Solriamfetol hydrochloride LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Solriamfetol hydrochloride
Administration Pathway
  • Oral
Therapeutic Areas
  • Central Nervous System
  • Respiratory
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.