glovadalen (UCB0022) / UCB - LARVOL DELTA

A Study to Assess the Safety and Tolerability, and Pharmacokinetics of UCB0022 in Healthy Caucasian, Japanese, and Chinese Participants (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: UCB Biopharma SRL

New P1 trial

ATLANTIS: A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of UCB0022 in Study Participants With Advanced Parkinson's Disease (clinicaltrials.gov) - P2 | N=207 | Completed | Sponsor: UCB Biopharma SRL | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Movement Disorders • Parkinson's Disease

DESIGNING A PATIENT -INFORMED TRIAL: ATLANTIS PHASE II STUDY OF THE D1 RECEPTOR PAM, UCB0022, IN ADVANCED PD (ADPD 2025) - P2 | "ATLANTIS is a proof -of-concept study, the design and implementation of which was shaped from the earliest stages by direct and consistent involvement of PwP. Findings from this study will inform future clinical development of UCB0022."

Clinical • Metastases • P2 data • CNS Disorders • Movement Disorders • Parkinson's Disease

ATLANTIS: A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of UCB0022 in Study Participants With Advanced Parkinson's Disease (clinicaltrials.gov) - P2 | N=193 | Active, not recruiting | Sponsor: UCB Biopharma SRL | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Movement Disorders • Parkinson's Disease

ATLANTIS: A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of UCB0022 in Study Participants With Advanced Parkinson's Disease (clinicaltrials.gov) - P2 | N=189 | Recruiting | Sponsor: UCB Biopharma SRL | Trial completion date: Dec 2024 ➔ Apr 2025 | Trial primary completion date: Dec 2024 ➔ Mar 2025

Metastases • Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

TRANSLATIONAL CHARACTERISATION OF UCB0022, A D1 RECEPTOR POSITIVE ALLOSTERIC MODULATOR, AND PHASE 1 SAFETY RESULTS INCLUDING PEOPLE WITH PARKINSON'S (ADPD 2024) - P1, P2 | "UCB0022 is a selective and potent D1PAM, able to improve motor disability in MPTP-treated macaques as effectively as levodopa, but with reduced severity of dyskinesia. In the Phase 1 study in healthy participants and PwP, UCB0022 demonstrated an acceptable safety and tolerability profile. These data support the progression of UCB0022 to a Phase 2 study (NCT06055985)."

Clinical • P1 data • CNS Disorders • Movement Disorders • Parkinson's Disease

ATLANTIS: A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of UCB0022 in Study Participants With Advanced Parkinson's Disease (clinicaltrials.gov) - P2 | N=189 | Recruiting | Sponsor: UCB Biopharma SRL | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Movement Disorders • Parkinson's Disease

ATLANTIS: A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of UCB0022 in Study Participants With Advanced Parkinson's Disease (clinicaltrials.gov) - P2 | N=189 | Not yet recruiting | Sponsor: UCB Biopharma SRL

Metastases • New P2 trial • CNS Disorders • Movement Disorders • Parkinson's Disease

Safety and tolerability of UCB0022, a dopamine 1 (D1) receptor modulator in people with Parkinson’s (PwP) and healthy participants: first results of a Phase 1 study (MDS Congress 2023) - P1 | "UCB0022 demonstrated an acceptable safety and tolerability profile in healthy participants and PwP. No new safety concerns were identified; there were no deaths, serious TEAEs or TEAEs of severe intensity reported in any part of the study. Titration reduced the incidence and severity of TEAEs and showed fewer effects on vital signs."

Clinical • Late-breaking abstract • P1 data • CNS Disorders • Parkinson's Disease

A Study to Test the Safety, Tolerability, and Blood Levels of UCB0022 in Healthy Participants and Participants With Parkinson's Disease (clinicaltrials.gov) - P1 | N=100 | Completed | Sponsor: UCB Biopharma SRL | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Movement Disorders • Parkinson's Disease

A Study to Test the Safety, Tolerability, and Blood Levels of UCB0022 in Healthy Participants and Participants With Parkinson's Disease (clinicaltrials.gov) - P1 | N=100 | Active, not recruiting | Sponsor: UCB Biopharma SRL | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Movement Disorders • Parkinson's Disease

Preclinical characterization of UCB0022, an oral, brain penetrant, selective, clinical-stage positive allosteric modulator of the dopamine 1 receptor (D1 PAM) (MDS Congress 2022) - "UCB0022 is a selective and potent D1 PAM, able to improve motor disability in MPTP-treated macaques as effectively as levodopa, but with a reduction in severe dyskinesia. Together with favorable PK and safety profiles, these data supported the progression of UCB0022 to first-in-human studies."

Preclinical • CNS Disorders • Parkinson's Disease

A Study to Test the Safety, Tolerability, and Blood Levels of UCB0022 in Healthy Participants and Participants With Parkinson's Disease (clinicaltrials.gov) - P1 | N=84 | Recruiting | Sponsor: UCB Biopharma SRL | Trial completion date: May 2022 ➔ Dec 2022 | Trial primary completion date: May 2022 ➔ Dec 2022

Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

A Study to Test the Safety, Tolerability, and Blood Levels of UCB0022 in Healthy Participants and Participants With Parkinson's Disease (clinicaltrials.gov) - P1; N=84; Recruiting; Sponsor: UCB Biopharma SRL; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • CNS Disorders • Movement Disorders • Parkinson's Disease

A Study to Test the Safety, Tolerability, and Blood Levels of UCB0022 in Healthy Participants and Participants With Parkinson's Disease (clinicaltrials.gov) - P1; N=84; Not yet recruiting; Sponsor: UCB Biopharma SRL

Clinical • New P1 trial • CNS Disorders • Movement Disorders • Parkinson's Disease