Lu AF28996 / Lundbeck - LARVOL DELTA

Oral D1-like/D2-like Receptor Agonist, Lu AF28996, Provides Robust Antiparkinsonian Efficacy with Reduced Dyskinesia in the MPTP-Macaque Model (MDS Congress 2026) - No abstract available

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

Lu AF28996, a Novel Oral D1-like/D2-like Receptor Agonist, May Improve Motor Complications in People with Parkinson’s Disease: Results from an 18-week open-label, Phase 1b Trial (MDS Congress 2026) - No abstract available

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

DARE2: A Trial Investigating Lu AF28996 in Adults With Parkinson's Disease Who Have Motor Fluctuations (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: H. Lundbeck A/S | Not yet recruiting ➔ Recruiting

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

A Trial of Lu AF28996 in Participants With Parkinson's Disease (PD) (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: H. Lundbeck A/S | Not yet recruiting ➔ Recruiting

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

The oral dopamine agonist Lu AF28996 provides sustained motor benefit with reduced dyskinesia in a preclinical rodent model of Parkinson’s disease (WPC 2026) - "In summary, acute and chronic Lu AF28996 administration to 6-OHDA rats resulted in long-lasting alleviation of motor function but with fewer treatment-induced dyskinesias than with levodopa. Future research in additional translational models is warranted to assess the therapeutic potential of Lu AF28996 in advanced PD."

Late-breaking abstract • Preclinical • CNS Disorders • Movement Disorders • Parkinson's Disease

Lu AF28996 may improve motor complications in patients with Parkinson’s disease and persistent OFF-time despite optimized treatment: Results from an open-label phase 1b trial (WPC 2026) - P1 | "Lu AF28996 demonstrated favorable tolerability, and robust improvements in motor fluctuations in patients with advanced PD and persistent OFF-time (≥2h) despite prior treatment optimization attempts, warranting onward clinical development in a similar patient population."

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

DARE2: A Trial Investigating Lu AF28996 in Adults With Parkinson's Disease Who Have Motor Fluctuations (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: H. Lundbeck A/S

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

A Trial of Lu AF28996 in Participants With Parkinson's Disease (PD) (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: H. Lundbeck A/S

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

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