serdexmethylphenidate oral (KP1077) / Zevra Therap - LARVOL DELTA

Duration and Efficacy of Azstarys on Adult ADHD Symptoms and Executive Function in Early Evening (clinicaltrials.gov) - P4 | N=29 | Completed | Sponsor: NYU Langone Health | Recruiting ➔ Completed | Trial completion date: Feb 2025 ➔ Jul 2024 | Trial primary completion date: Dec 2024 ➔ Jul 2024

Trial completion • Trial completion date • Trial primary completion date • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Placebo-Controlled, Double-Blind, Study to Determine the Safety and Efficacy of SDX in Patients With IH (clinicaltrials.gov) - P2 | N=50 | Completed | Sponsor: Zevra Therapeutics | Active, not recruiting ➔ Completed | Trial completion date: Jun 2024 ➔ Mar 2024 | Trial primary completion date: Jun 2024 ➔ Feb 2024

Trial completion • Trial completion date • Trial primary completion date • Sleep Disorder

SAFETY AND EFFICACY OF KP1077 IN A PHASE 2, DOUBLE-BLIND, RANDOMIZED TRIAL IN PATIENTS WITH IDIOPATHIC HYPERSOMNIA (SLEEP 2024) - "The active ingredient in KP1077 is serdexmethylphenidate (SDX), a prodrug of d-methylphenidate. KP1077 was well-tolerated in patients with IH with AEs typical for a central nervous system stimulant. Meaningful clinical improvements of EDS, sleep inertia and brain fog were observed after 5 weeks of OL KP1077."

Clinical • P2 data • CNS Disorders • Excessive Daytime Sleepiness • Insomnia • Pain • Psychiatry • Sleep Disorder • Suicidal Ideation

Placebo-Controlled, Double-Blind, Study to Determine the Safety and Efficacy of SDX in Patients With IH (clinicaltrials.gov) - P2 | N=48 | Active, not recruiting | Sponsor: Zevra Therapeutics | Recruiting ➔ Active, not recruiting | Trial completion date: Jan 2024 ➔ Jun 2024 | Trial primary completion date: Oct 2023 ➔ Jun 2024

Enrollment closed • Trial completion date • Trial primary completion date • Sleep Disorder

Duration and Efficacy of Azstarys on Adult ADHD Symptoms and Executive Function in Early Evening (clinicaltrials.gov) - P4 | N=30 | Recruiting | Sponsor: NYU Langone Health | Not yet recruiting ➔ Recruiting

Enrollment open • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Duration and Efficacy of Azstarys on Adult ADHD Symptoms and Executive Function in Early Evening (clinicaltrials.gov) - P4 | N=30 | Not yet recruiting | Sponsor: NYU Langone Health

New P4 trial • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Zevra Therapeutics Announces FDA Acceptance of IND Application for KP1077 in Narcolepsy - "Zevra Therapeutics...today announced the acceptance of an Investigational New Drug ('IND') application by the U.S. Food and Drug Administration ('FDA') to begin a Phase 1 clinical trial of KP1077 in narcolepsy which is expected to provide additional information regarding the optimal dosing regimen. Zevra plans to initiate the first of several Phase 1 clinical trials of KP1077 in narcolepsy this year."

IND • New P1 trial • CNS Disorders • Sleep Disorder

"$ZVRA Zevra Therapeutics Announces Submission of IND for KP1077 in Narcolepsy https://t.co/ZjG0U8FRdy" (@stock_titan)

Narcolepsy • Sleep Disorder