Which parkinson's disease drugs are in Phase 3?

Phase 3 (or later) programs for parkinson's disease include Tavapadon.

What are the next parkinson's disease trial readouts?

Upcoming catalysts include Lenrispodun (ITI-214) (2025), Tavapadon (FDA decision expected 1H 2026) and BHV-8000 (2H 2027).

How many clinical trials are recruiting for parkinson's disease?

123 drug-interventional parkinson's disease trials are currently recruiting participants, out of 1,331 registered interventional trials.

Neurocognitive Disorders

Parkinson's disease drug pipeline

ICD-11 8A00.0
MeSH D010300

Subtypes: Parkinson's disease psychosis

3 compounds from 3 companies are in active clinical development for parkinson's disease, including 1 at Phase 3 or beyond.

3Compounds

3Companies

1Phase 3+

3Upcoming readouts

160Trials recruiting

Filed (NDA) 1
Phase 2/3 1
Phase 2 1

Mechanisms: Small molecule (3)

Pipeline data compiled July 2026 · every fact sourced.

Upcoming readouts & recent results

2025DelayedLenrispodun (ITI-214)Topline dataNCT05766813
Phase 2 ITI-214-202 topline in Parkinson's disease (lenrispodun 30 mg vs placebo, Hauser-diary primary at Day 29). ↗
FDA decision expected 1H 2026AnticipatedTavapadonRegulatory
FDA decision on the tavapadon NDA anticipated in the first half of 2026. ↗
2H 2027AnticipatedBHV-8000Topline dataNCT06976268
Anticipated Phase 2/3 topline in early Parkinson's disease (primary endpoint: time to first qualifying worsening on MDS-UPDRS Part II) ↗
2025-09-26ReportedTavapadonRegulatory
AbbVie submitted the tavapadon NDA to the U.S. FDA for early and advanced Parkinson's disease. ↗
2024-12-09ReportedTavapadonTopline datametNCT04223193
TEMPO-2 (flexible-dose monotherapy, early PD) met primary endpoint: -9.1 point treatment difference on MDS-UPDRS II+III (p<0.0001). ↗
2024-09-26ReportedTavapadonTopline datametNCT04201093
TEMPO-1 (fixed-dose monotherapy, early PD) met primary endpoint at both 5 mg and 15 mg (p<0.0001 vs placebo). ↗
2024-04-18ReportedTavapadonTopline datametNCT04542499
TEMPO-3 (adjunctive to levodopa, advanced PD) met primary endpoint: +1.1 h additional ON time without troublesome dyskinesia vs placebo (p<0.0001). ↗

See the full catalyst calendar →

Compounds in development (3)

Compound	Company	Phase	Status	Mechanism
Tavapadon	AbbVie Inc.	Filed (NDA)	Active	D1 receptor Partial agonist
BHV-8000	Biohaven Ltd.	Phase 2/3	Recruiting	TYK2 Inhibitor
Lenrispodun (ITI-214)	Johnson & Johnson	Phase 2	Active	PDE1B Inhibitor

Trials recruiting now (123)

123 drug-interventional parkinson's disease trials recruiting now, of 1,331 registered interventional trials. Browse all on ClinicalTrials.gov →

Phase 4Effects of Lemborexant on Motor-sleep Comorbidity in Parkinson's Disease
Lemborexant, placebo
YangPann=44China · 1 siteStarted Aug 2026NCT07384429
Phase 4Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease
mirabegron
VA Office of Research and Developmentn=146United States · 3 sitesStarted Jul 2026NCT07187466
Phase 4Pilot Deprescribing of Antimuscarinic Overactive Bladder Medications in Parkinson Disease
Overactive bladder antimuscarinic deprescribing
Corporal Michael J. Crescenz VA Medical Centern=20United States · 1 siteStarted Jun 2026NCT07627529
Phase 4Elucidating the Role of Cholinergic Degeneration in Cognitive Fluctuations in Lewy Body Dementia
Galantamine HBr extended-release 8mg capsules (8mg ER).
Virginia Commonwealth Universityn=120United States · 1 siteStarted Dec 2025NCT07284290
Phase 4BOOST-PD A Naturalistic Study on IPX-203 for Parkinson's Disease
CREXONT ER
The Cleveland Clinicn=22United States · 1 siteStarted Jul 2025NCT07138560
Phase 4A Study of CREXONT (Carbidopa and Levodopa) Extended-Release Capsules in Participants With Parkinson's Disease
CREXONT ER
Impax Laboratories, LLCn=220United States · 27 sitesStarted Feb 2025NCT06765668
Phase 4Vortioxetine for Depressive Symptoms and Freezing of Gait in Parkinson Disease
Vortioxetine (tablet)
Marianna Ambonin=40Started Feb 2025NCT06805266
Phase 4DBS and Levodopa for Treating Freezing of Gait in Parkinson's Disease
MED ON plus
IRCCS Istituto delle Scienze Neurologiche di Bolognan=20Italy · 1 siteStarted Oct 2023NCT06316232
Phase 4Personalized Real-Time DBS and PD Mechanisms
Carbidopa 25/Levodopa 100Mg Tab
David Escobarn=25United States · 1 siteStarted Aug 2023NCT06013956
Phase 4Characterization of the Serotonin 2A Receptor Selective PET Tracer [18F]MH.MZ in Patients With Neurodegenerative Diseases
Pimavanserin
Vanderbilt University Medical Centern=75United States · 1 siteStarted Jan 2023NCT05357612
Phase 4Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis
Pimavanserin, Quetiapine
VA Office of Research and Developmentn=358United States · 24 sitesStarted Oct 2022NCT04373317
Phase 4Multimodal Image Technologies Investigate the Role and Mechanism of Probiotics in Improving RBD with Parkinson's Disease
PD-RBD, iRBD
Beijing Friendship Hospitaln=120China · 1 siteStarted Sep 2022NCT06710574

Showing the 12 most advanced of 123 recruiting drug trials · see all on ClinicalTrials.gov →

Frequently asked

How many drugs are in development for parkinson's disease?: 3 compounds from 3 companies are in active clinical development for parkinson's disease, including 1 at Phase 3 or beyond.
Which parkinson's disease drugs are in Phase 3?: Phase 3 (or later) programs for parkinson's disease include Tavapadon.
What are the next parkinson's disease trial readouts?: Upcoming catalysts include Lenrispodun (ITI-214) (2025), Tavapadon (FDA decision expected 1H 2026) and BHV-8000 (2H 2027).
How many clinical trials are recruiting for parkinson's disease?: 123 drug-interventional parkinson's disease trials are currently recruiting participants, out of 1,331 registered interventional trials.