samelisant (SUVN-G3031) / Suven Life Sci - LARVOL DELTA

A Phase 3 Study to Evaluate the Efficacy and Safety of Samelisant in Patients With Narcolepsy (AWAKE) (clinicaltrials.gov) - P3 | N=240 | Recruiting | Sponsor: Suven Life Sciences Limited | Not yet recruiting ➔ Recruiting

Enrollment open • Cataplexy • Narcolepsy • Sleep Disorder

A Phase 3 Study to Evaluate the Efficacy and Safety of Samelisant in Patients With Narcolepsy (clinicaltrials.gov) - P3 | N=240 | Not yet recruiting | Sponsor: Suven Life Sciences Limited

New P3 trial • Cataplexy • Narcolepsy • Sleep Disorder

Samelisant (SUVN-G3031) for the Treatment of Cataplexy in Patients With Narcolepsy Type-one: Rationale and Study Design of a Phase-two Study (AAN 2026) - "The primary objective of the study will be to evaluate changes in weekly cataplexy rates in NT1 patients. Conclusions The Phase-2 study results will inform the therapeutic utility and safety of Samelisant for the treatment of cataplexy in NT1 patients."

Clinical • Cardiovascular • Cataplexy • CNS Disorders • Narcolepsy • Sleep Disorder

Samelisant (SUVN-G3031), a histamine H3 receptor inverse agonist, as a potential treatment for narcolepsy: a phase-2 Drug evaluation. (PubMed, Expert Opin Investig Drugs) - "This is particularly important for women of childbearing potential, considering the known interactions of current treatments (e.g. pitolisant and modafinil) with hormonal contraceptives, as well as the common occurrence of polypharmacy and comorbidities in narcolepsy. Additionally, as samelisant may act downstream of orexinergic pathways, it presents an opportunity to complement orexin-based therapies. The potential of samelisant in combination with other narcolepsy treatments represents an important area for future research."

Journal • P2 data • Review • Cardiovascular • Cataplexy • CNS Disorders • Excessive Daytime Sleepiness • Narcolepsy • Sleep Disorder

Rationale and Study Design of the Phase-3 Clinical Development Program for Samelisant (SUVN-G3031) in the Treatment of Excessive Daytime Sleepiness in Patients with Narcolepsy (Neuroscience 2025) - P2 | "Secondary endpoints are change from Baseline to Week 12 in Maintenance of Wakefulness Test score, CGI-S score and Narcolepsy Severity Scale score. Phase-3 study will be initiated in H2 2025 and results from this study may inform the therapeutic utility of Samelisant for the treatment narcolepsy."

Clinical • P3 data • Cataplexy • CNS Disorders • Excessive Daytime Sleepiness • Narcolepsy • Sleep Disorder

Samelisant, a potent and selective histamine H3 receptor inverse agonist: safety, tolerability and pharmacokinetics following single and multiple ascending doses in healthy subjects (WSS 2025) - P1 | "Samelisant has favourable safety and pharmacokinetic profile after single and multiple dose administration for 14 days in healthy adult subjects. Following single or multiple oral administrations, Samelisant exposures were approximately dose proportional at the tested doses. Samelisant was well tolerated in humans with adequate plasma exposure for efficacy and favorable pharmacokinetics suitable for once a day oral administration."

Clinical • PK/PD data • Cataplexy • CNS Disorders • Excessive Daytime Sleepiness • Narcolepsy • Psychiatry • Sleep Disorder • Suicidal Ideation

Rationale and Study Design of Phase-3 Clinical Development Program for Samelisant (SUVN-G3031) in the Treatment of Excessive Daytime Sleepiness in Patients with Narcolepsy (WSS 2025) - P2 | "The Phase-3 study is expected to begin in the second half of 2025. Study results from this Phase-3 study will provide further insight into the therapeutic potential of Samelisant for the treatment of narcolepsy."

Clinical • P3 data • Cataplexy • CNS Disorders • Excessive Daytime Sleepiness • Narcolepsy • Sleep Disorder

Samelisant (SUVN-G3031) Alleviates Excessive Daytime Sleepiness in Narcolepsy Patients: Results from a Phase-2 Study (WSS 2025) - P2 | "Samelisant holds promise as a monotherapy for the treatment of EDS in narcolepsy, and a global Phase-3 study will be initiated in H2 2025 to evaluate its efficacy in narcoleptic patients."

Clinical • P2 data • Cataplexy • CNS Disorders • Excessive Daytime Sleepiness • Excessive Daytime Sleepiness in Narcolepsy • Narcolepsy • Psychiatry • Sleep Disorder • Suicidal Ideation

Rationale and Study Design for the Evaluation of Samelisant (SUVN-G3031) in a Phase-2 Study for the Treatment of Cataplexy in Patients with Narcolepsy (WSS 2025) - "Outcomes from animal models of narcolepsy suggest that Samelisant may have anticataplectic effects. The Phase-2 study results will inform the therapeutic utility of Samelisant for the treatment of cataplexy in NT1 patients."

Clinical • P2 data • Cataplexy • CNS Disorders • Narcolepsy • Sleep Disorder

Samelisant (SUVN-G3031): Positive Results from Phase-2 Proof-of-concept, Double-blind, Placebo-controlled Study in Patients with Narcolepsy and an Update on Further Clinical Development (AAN 2025) - P2 | "Samelisant could be a potential new therapy for the management of EDS and cataplexy in patients with narcolepsy. A Phase-3 study for the treatment of EDS in narcolepsy and a Phase-2 POC study for the treatment of cataplexy in narcolepsy are being planned."

Clinical • P2 data • Cataplexy • Excessive Daytime Sleepiness • Narcolepsy • Sleep Disorder

Samelisant (SUVN-G3031), a histamine 3 receptor inverse agonist: Results from the phase 2 double-blind randomized placebo-controlled study for the treatment of excessive daytime sleepiness in adult patients with narcolepsy. (PubMed, Sleep Med) - P2 | "The AEs reported in ≥5 % patients in any treatment groups were insomnia, abnormal dreams, nausea, and hot flush. Global phase 3 studies and long-term safety and efficacy assessments of Samelisant are planned to reaffirm the current findings."

Journal • P2 data • Cataplexy • CNS Disorders • Excessive Daytime Sleepiness • Insomnia • Narcolepsy • Sleep Disorder

Samelisant (SUVN-G3031): Safety and Efficacy Outcome from the Phase-2 Proof-of-Concept, Double-Blind, Placebo-Controlled Study in Patients with Narcolepsy (Neuroscience 2024) - P2 | "Samelisant could be a potential new therapy for the management of narcolepsy. Suven is planning end-of-phase-2 meeting with the FDA and a Phase-3 study for the treatment of EDS in narcolepsy is being planned."

Clinical • P2 data • Cataplexy • CNS Disorders • Excessive Daytime Sleepiness • Narcolepsy • Sleep Disorder

SAMELISANT: CLINICIAN AND PATIENT GLOBAL IMPRESSION FROM A DOUBLE-BLIND, PHASE-2 STUDY IN PATIENTS WITH NARCOLEPSY (SLEEP 2024) - P2 | "Treatment with samelisant as monotherapy resulted in significant improvement in excessive day time sleepiness as assessed by both clinicians and patients. These outcomes sup port the efficacy of samelisant observed in the primary endpoint, ESS, in patients with narcolepsy with or without cataplexy"

Clinical • P2 data • Cataplexy • CNS Disorders • Excessive Daytime Sleepiness • Narcolepsy • Sleep Disorder

SAMELISANT IMPROVES THE SYMPTOMS OF EXCESSIVE DAYTIME SLEEPINESS IN NARCOLEPSY: RESULTS FROM A PHASE-2 STUDY (SLEEP 2024) - P2 | "Samelisant holds promise as a monotherapy treat ment of EDS in narcolepsy."

P2 data • Cataplexy • CNS Disorders • Excessive Daytime Sleepiness • Excessive Daytime Sleepiness in Narcolepsy • Narcolepsy • Sleep Disorder

Samelisant (SUVN-G3031) - Topline Results from the Phase-2 Proof-of-Concept Double-blind, Placebo-controlled Study in Patients with Narcolepsy (AAN 2024) - P2 | "Samelisant could be a potential new therapy for the management of narcolepsy"

Clinical • P2 data • Cataplexy • Excessive Daytime Sleepiness • Narcolepsy • Sleep Disorder

Samelisant (SUVN-G3031): Topline results from the phase-2 proof-of-concept double blind, placebo controlled study in patients with narcolepsy (Neuroscience 2023) - P2 | "The enrolment for the study has been completed and data readout from the study is expected in August 2023. Phase-2 study results covering efficacy and safety data from this study will be presented during the Neuroscience 2023 meeting."

Clinical • P2 data • Cataplexy • CNS Disorders • Excessive Daytime Sleepiness • Excessive Daytime Sleepiness in Narcolepsy • Narcolepsy • Psychiatry • Sleep Disorder

Samelisant (SUVN-G3031), a potent and selective histamine 3 receptor inverse agonist for the potential treatment of excessive daytime sleepiness in patients with narcolepsy with and without cataplexy (Neuroscience 2023) - P2 | "Baseline characteristics are consistent with the general narcolepsy population. The data readout from this study is expected in August 2023."

Clinical • Cataplexy • CNS Disorders • Excessive Daytime Sleepiness • Excessive Daytime Sleepiness in Narcolepsy • Narcolepsy • Sleep Disorder

A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy (clinicaltrials.gov) - P2 | N=190 | Completed | Sponsor: Suven Life Sciences Limited | Active, not recruiting ➔ Completed

Trial completion • Cataplexy • Narcolepsy • Sleep Disorder

Samelisant, a H3 Receptor Inverse Agonist for the Potential Treatment of Excessive Daytime Sleepiness in Parkinson’s Disease (SLEEP 2023) - P2 | "Treatment with samelisant produced dose- dependent increase in wake with decrease in REM and NREM periods in quinpirole treated hemiparkinsonian rats. Conclusion The results from current preclinical studies indicate that samelisant may have a potential utility for the treatment of excessive daytime sleepiness in PD patients."

Cataplexy • CNS Disorders • Excessive Daytime Sleepiness • Narcolepsy • Parkinson's Disease • Sleep Disorder

Samelisant, Histamine 3 Receptor Agonist for the Potential Treatment of Excessive Daytime Sleepiness in Patients with Narcolepsy (SLEEP 2023) - P2 | "Conclusion Baseline characteristics are consistent with the general narcolepsy population. The study is currently enrolling subjects with narcolepsy and the data readout is expected in Q2 2023."

Clinical • Cataplexy • CNS Disorders • Excessive Daytime Sleepiness • Narcolepsy • Sleep Disorder

A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy (clinicaltrials.gov) - P2 | N=189 | Active, not recruiting | Sponsor: Suven Life Sciences Limited | Recruiting ➔ Active, not recruiting

Enrollment closed • Cataplexy • Narcolepsy • Sleep Disorder

Suven Life Sciences : June 01, 2023Suven completed enrollment of patients to the phase-2(PoC) clinical study of SUVN-G3031 in US,CANADA (Market Screener) - "Suven Life Sciences...announced completion of enrollment for its phase-2 PoC clinical study evaluating the safety and efficacy of samelisant in adult narcolepsy patients with and without cataplexy. Data readout for the study is anticipated in second quarter of FY2024."

Enrollment closed • P2 data • Cataplexy • CNS Disorders • Narcolepsy

Expanded Access to SUVN-G3031 (Samelisant) for the Treatment of Subjects With Narcolepsy (clinicaltrials.gov) - P=N/A | N=N/A | Available | Sponsor: Suven Life Sciences Limited

New trial • Narcolepsy • Sleep Disorder

SAMELISANT (SUVN-G3031), BASELINE CHARACTERISTICS FROM A PHASE-2 STUDY EVALUATING EFFICACY AND SAFETY IN PATIENTS WITH NARCOLEPSY (SLEEP 2022) - P2 | "Baseline characteristics are consistent with the general narcolepsy population. The study is currently enrolling subjects with narcolepsy and the data readout is expected in Q3 2022."

Clinical • P2 data • Cataplexy • Excessive Daytime Sleepiness • Narcolepsy • Sleep Disorder

SAMELISANT (SUVN-G3031), A HISTAMINE H3 RECEPTOR INVERSE AGONIST IN ANIMAL MODELS OF NARCOLEPSY (SLEEP 2022) - P2 | "The results from non-clinical studies presented here provide a strong evidence for the potential utility of samelisant for the treatment of EDS and cataplexy in patients with narcolepsy."

Preclinical • Cataplexy • CNS Disorders • Excessive Daytime Sleepiness • Narcolepsy • Sleep Disorder