XW10172 / XWPharma - LARVOL DELTA

Pharmacokinetics, Safety, and Tolerability of Various XW10172 Oral Formulations in Healthy Adult Volunteers (clinicaltrials.gov) - P1 | N=46 | Completed | Sponsor: XWPharma | Recruiting ➔ Completed

Trial completion

Pharmacokinetics, Safety, and Tolerability of Various XW10172 Oral Formulations in Healthy Adult Volunteers (clinicaltrials.gov) - P1; N=50; Recruiting; Sponsor: XWPharma; Active, not recruiting ➔ Recruiting

Clinical • Enrollment open

XW10172: “XW10172 exhibits rapid absorption and fast cleavage to release the GABAB agonist oxybate, producing oxybate exposures matching sodium oxybate at equal molar doses”; Sleep disorder (XWPharma) - SLEEP 2021 : “MR formulations of XW10172 have demonstrated clinical PK suitable for once-nightly dosing with a rapid increase in oxybate concentrations following administration, sustained oxybate concentrations throughout the night, and low oxybate concentrations at waking hours”

P1 data • Sleep Disorder

XWPharma Announces Positive Results from Phase 1 Clinical Trials of XW10172, in Development as Once-Nightly Therapy for Sleep Disorders in Patients with Neurodegenerative Diseases (Businesswire) - "Data Support Continued Development of XW10172; Phase 2 Trial in Sleep Disorders in Patients with Parkinson’s Disease is planned to start 3Q2021 followed by Single Registrational Trial in Narcolepsy...XWPharma Ltd. today announced that XW10172...demonstrated in Phase 1 clinical trials multiple features that support development for treatment for various sleep disorders. The results of these studies were presented by Daniel Canafax, PharmD, Chief Medical Officer of the company, in a podium presentation at virtual SLEEP 2021, the annual meeting of the Associated Professional Sleep Societies."

New P2 trial • P1 data • CNS Disorders • Parkinson's Disease • Sleep Disorder

Pharmacokinetics, Safety, and Tolerability of Various XW10172 Oral Formulations in Healthy Adult Volunteers (clinicaltrials.gov) - P1; N=49; Active, not recruiting; Sponsor: XWPharma; Trial completion date: May 2021 ➔ Oct 2021; Trial primary completion date: May 2021 ➔ Oct 2021

Clinical • Trial completion date • Trial primary completion date

XWPharma Announces Abstract for XW10172 Accepted for Presentation at the Associated Professional Sleep Societies SLEEP 2021 Annual Meeting (GlobeNewswire) - "XWPharma Ltd. today announced that data from clinical research of XW10172, a new chemical entity (NCE) in development for the treatment of sleep disorders associated with neurodegenerative diseases and narcolepsy, has been accepted for poster and oral presentation at the Associated Professional Sleep Societies SLEEP 2021 Annual Meeting, which will be held virtually from June 10-13, 2021."

Clinical data • CNS Disorders • Narcolepsy • Parkinson's Disease • Sleep Disorder

[VIRTUAL] Clinical PK of XW10172 for Once Nightly Therapy in Patients with Narcolepsy or Sleep Disorders in Neurodegenerative Diseases (SLEEP 2021) - "XW10172 was generally well tolerated and adverse events were those known to be associated with oxybate. Conclusion These data support progression of XW10172 (ER) in further clinical development studies to assess this once nightly GABA-B agonist therapy for the treatment of patients with various sleep disorders."

Clinical • CNS Disorders • Narcolepsy • Sleep Disorder

Pharmacokinetics, Safety, and Tolerability of Various XW10172 Oral Formulations in Healthy Adult Volunteers (clinicaltrials.gov) - P1; N=49; Active, not recruiting; Sponsor: XWPharma; Recruiting ➔ Active, not recruiting; N=36 ➔ 49

Clinical • Enrollment change • Enrollment closed

Pharmacokinetics, Safety, and Tolerability of Various XW10172 Oral Formulations in Healthy Adult Volunteers (clinicaltrials.gov) - P1; N=36; Recruiting; Sponsor: XWPharma

Clinical • New P1 trial