Lu AF28996 / Lundbeck - LARVOL DELTA

D1/D2-RECEPTOR AGONIST LU AF28996: PROMISING TOLERABILITY AND MARKED MOTOR-FLUCTUATION IMPROVEMENT IN PEOPLE WITH PARKINSON'S DISEASE WITH/WITHOUT DYSKINESIA – OPEN-LABEL PHASE-1B RESULTS (ADPD 2026) - P1 | "Preliminary findings indicate that Lu AF28996 was well tolerated, with the potential to markedly improve motor fluctuations despite levodopa dose reductions in people with advanced PD, with an apparent beneficial effect on dyskinesia, warranting onward clinical development."

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

Lundbeck advances Parkinson's research with new Phase 1b data (Scientist Live) - "Results from the trial indicated that Lu AF28996 was generally well tolerated and demonstrated early signals consistent with its proposed mechanism of action, supporting clinical development...Lunbeck will also be presenting insights into multiple system atrophy (MSA), a rapidly progressing and fatal neurodegenerative disease for which no approved treatments currently exist...The data will highlight advances in understanding MSA disease progression and the advantages of Bayesian progression modelling for assessing clinical trial outcomes in MSA...Presentations will also emphasise the importance of integrating patient perspectives into MSA trial design and of advancing biomarker development to enable earlier diagnosis. These learnings have informed Lundbeck’s amlenetug pivotal program in MSA."

Clinical • P1 data • Multiple System Atrophy • Parkinson's Disease

Lu AF28996 in Participants With Parkinson's Disease (PD) (clinicaltrials.gov) - P1 | N=57 | Completed | Sponsor: H. Lundbeck A/S | Active, not recruiting ➔ Completed

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

Lu AF28996 in Participants With Parkinson's Disease (PD) (clinicaltrials.gov) - P1 | N=57 | Active, not recruiting | Sponsor: H. Lundbeck A/S | Recruiting ➔ Active, not recruiting

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

Lu AF28996 in Participants With Parkinson's Disease (PD) (clinicaltrials.gov) - P1 | N=63 | Recruiting | Sponsor: H. Lundbeck A/S | Trial completion date: Jul 2025 ➔ Feb 2026 | Trial primary completion date: Jul 2025 ➔ Oct 2025

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

A Study Investigating the Movement of Lu AF28996 Into, Through, and Out of the Body of Healthy Men (clinicaltrials.gov) - P1 | N=8 | Completed | Sponsor: H. Lundbeck A/S | Recruiting ➔ Completed

Trial completion

A Trial Investigating Lu AF28996 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=22 | Completed | Sponsor: H. Lundbeck A/S | Active, not recruiting ➔ Completed

Trial completion

A Study Investigating the Movement of Lu AF28996 Into, Through, and Out of the Body of Healthy Men (clinicaltrials.gov) - P1 | N=8 | Recruiting | Sponsor: H. Lundbeck A/S | Not yet recruiting ➔ Recruiting

Enrollment open

A Trial Investigating Lu AF28996 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=22 | Active, not recruiting | Sponsor: H. Lundbeck A/S | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study Investigating the Movement of Lu AF28996 Into, Through, and Out of the Body of Healthy Men (clinicaltrials.gov) - P1 | N=8 | Not yet recruiting | Sponsor: H. Lundbeck A/S

New P1 trial

A Trial Investigating Lu AF28996 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: H. Lundbeck A/S | Not yet recruiting ➔ Recruiting

Enrollment open

A Trial Investigating Lu AF28996 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: H. Lundbeck A/S

New P1 trial

Lu AF28996 in Participants With Parkinson's Disease (PD) (clinicaltrials.gov) - P1 | N=77 | Recruiting | Sponsor: H. Lundbeck A/S | N=29 ➔ 77 | Trial completion date: Oct 2023 ➔ Jul 2025 | Trial primary completion date: Oct 2023 ➔ Jul 2025

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

A Trial Investigating Lu AF28996 in Adult Japanese Participants With Parkinson's Disease (PD) (clinicaltrials.gov) - P1 | N=6 | Completed | Sponsor: H. Lundbeck A/S | Active, not recruiting ➔ Completed

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

A Trial Investigating Lu AF28996 in Adult Japanese Participants With Parkinson's Disease (PD) (clinicaltrials.gov) - P1 | N=6 | Active, not recruiting | Sponsor: H. Lundbeck A/S | Recruiting ➔ Active, not recruiting

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

A Trial Investigating Lu AF28996 in Adult Japanese Participants With Parkinson's Disease (PD) (clinicaltrials.gov) - P1 | N=6 | Recruiting | Sponsor: H. Lundbeck A/S | Not yet recruiting ➔ Recruiting

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

A Trial Investigating Lu AF28996 in Adult Japanese Participants With Parkinson's Disease (PD) (clinicaltrials.gov) - P1 | N=6 | Not yet recruiting | Sponsor: H. Lundbeck A/S

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

Lu AF28996 in Participants With Parkinson's Disease (PD) (clinicaltrials.gov) - P1 | N=37 | Recruiting | Sponsor: H. Lundbeck A/S | N=17 ➔ 37 | Trial completion date: Sep 2022 ➔ Aug 2023 | Trial primary completion date: Sep 2022 ➔ Aug 2023

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

Lu AF28996 in Participants With Parkinson's Disease (PD) (clinicaltrials.gov) - P1; N=17; Recruiting; Sponsor: H. Lundbeck A/S; Trial primary completion date: Dec 2021 ➔ Sep 2022

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

Lu AF28996 in Participants With Parkinson's Disease (PD) (clinicaltrials.gov) - P1; N=17; Recruiting; Sponsor: H. Lundbeck A/S; Trial completion date: Dec 2021 ➔ Jul 2022

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

Lu AF28996 in Participants With Parkinson's Disease (PD) (clinicaltrials.gov) - P1; N=17; Recruiting; Sponsor: H. Lundbeck A/S; N=10 ➔ 17

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

Lu AF28996 in Patients With Parkinson's Disease (PD) (clinicaltrials.gov) - P1; N=10; Recruiting; Sponsor: H. Lundbeck A/S; Trial completion date: Dec 2020 ➔ Dec 2021; Trial primary completion date: Dec 2020 ➔ Dec 2021

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

Lu AF28996 in Patients With Parkinson's Disease (PD) (clinicaltrials.gov) - P1; N=10; Recruiting; Sponsor: H. Lundbeck A/S

Clinical • New P1 trial

Single Dose of Lu AF28996 to Healthy Young Men (clinicaltrials.gov) - P1; N=39; Completed; Sponsor: H. Lundbeck A/S; Recruiting ➔ Completed; N=18 ➔ 39; Trial completion date: Mar 2019 ➔ Aug 2019; Trial primary completion date: Mar 2019 ➔ Aug 2019

Clinical • Enrollment change • Trial completion • Trial completion date • Trial primary completion date