Juvmo (tavapadon) / AbbVie - LARVOL DELTA

US FDA approves AbbVie's drug for Parkinson's disease (Reuters) - "The drug tavapadon, which AbbVie gained access to through its $8.7 billion acquisition of Cerevel Therapeutics in 2023, comes ​as a once-a-day pill....It will be sold ​under the brand name Juvmo, according to the ⁠FDA's website....The regulator's nod was based on data from AbbVie's ‌late-stage ⁠trial program which showed the drug improved symptoms in patients with the disease."

FDA approval • Parkinson's Disease

Institute for Clinical and Economic Review Releases Evidence Report on Treatment for Parkinson’s Disease (Institute for Clinical and Economic Review) - "Key Clinical Findings: (i) For Early Parkinson’s Disease: Tavapadon compared to no pharmacological treatment: ICER found tavapadon has a moderate certainty of a small to substantial net health benefit in populations where patients were taking no pharmacological treatment, resulting in an ICER evidence rating of C++; (ii) For Parkinson’s Disease with Motor Fluctuations: Tavapadon plus levodopa compared to levodopa alone: ICER found tavapadon plus levodopa has a moderate certainty of a small to substantial net health benefit compared to levodopa alone, resulting in an ICER evidence rating of C++; (iii) For Early Parkinson’s disease and for Parkinson’s disease with Motor Fluctuations: Tavapadon compared to four different types of medications...: ICER found, for all comparisons, given the mixed results and low certainty of evidence, the net health benefit is promising, but inconclusive (P/I)."

HEOR • Parkinson's Disease

Comparative Effectiveness of Tavapadon Versus Real-world Oral Standard of Care Treatments in Parkinson’s Disease With Motor Fluctuations: an Indirect Comparison Analysis (MDS Congress 2026) - No abstract available

Clinical • HEOR • Real-world • Real-world evidence • CNS Disorders • Movement Disorders • Parkinson's Disease

Levodopa Initiation in Phase 3 Trials of Tavapadon, a Selective D1/D5 Agonist for Early Parkinson’s Disease (MDS Congress 2026) - No abstract available

New P3 trial • P3 data • CNS Disorders • Movement Disorders • Parkinson's Disease

Exploratory Efficacy Analysis of Tavapadon Versus MAO-B Inhibitors in People With Early Parkinson’s Disease (MDS Congress 2026) - No abstract available

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

Changes in Continuous Good ON and Best ON Time During the Waking Day With Tavapadon in People With Parkinson’s Disease (MDS Congress 2026) - No abstract available

CNS Disorders • Movement Disorders • Parkinson's Disease

DRI Healthcare…announced that it has entered into purchase agreements to acquire certain royalty participation rights in U.S. net sales of tavapadon from funds managed by Bain Capital ('Bain') and NovaQuest Capital Management ('NovaQuest') (Canada Newswire) - "The transaction is expected to close following approval of tavapadon by the U.S. Food and Drug Administration ('FDA') and the satisfaction of other customary closing conditions. Tavapadon, an investigational Parkinson's disease drug candidate, is a novel selective D1/D5 receptor partial agonist that was studied as a once-daily oral medicine for Parkinson's disease for use both with and without levodopa. Tavapadon has been submitted to the FDA for approval and approval is expected in Q3 2026....Under the terms of the purchase agreements, DRI Healthcare will pay an aggregate purchase price of US$316 million at closing."

Commercial • FDA approval • Parkinson's Disease

"Efficacy, safety and certainty of evidence for selective D1/D5 dopamine receptor partial agonists in Parkinson's disease: a systematic review, meta-analysis and GRADE assessment". (PubMed, Neurol Sci) - "Selective D1/D5 partial agonism improves motor function in early-stage and levodopa-treated Parkinson's disease, at moderate certainty. Its proposed neuropsychiatric advantage over D2/D3 agonists remains untested: no trial used an active comparator or exceeded 27 weeks."

Clinical • Journal • Retrospective data • Review • CNS Disorders • Movement Disorders • Parkinson's Disease • Psychiatry

Cardiovascular pharmacology of dopaminergic agents in humans: a review. (PubMed, Clin Auton Res) - "The cardiovascular response to dopaminergic agents depends on receptor selectivity, intrinsic activity, and baroreflex integrity. The discrepancy between murine-knockout-predicted hypertension and human pharmacological neutrality with antagonists, and the hypertensive effects of dopamine D1 positive allosteric modulators, represent key unresolved questions."

Journal • Review • Cardiovascular • CNS Disorders • Hypertension • Hypotension • Mental Retardation • Movement Disorders • Parkinson's Disease • Psychiatry

Tavapadon for the treatment of Parkinson's disease. (PubMed, Lancet Neurol) - No abstract available

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

Safety, tolerability, and efficacy of flexible-dose tavapadon for Parkinson's disease (TEMPO-2): a phase 3, randomised, placebo-controlled, double-blind trial. (PubMed, Lancet Neurol) - P3 | "Tavapadon showed significant and clinically meaningful improvements in Parkinson's disease motor symptoms, with low incidence of somnolence and impulse control disorders. However, the short observation period limits conclusions about long-term tolerability. An ongoing extension study aims to confirm its long-term safety and efficacy."

Journal • P3 data • CNS Disorders • Movement Disorders • Pain • Parkinson's Disease

Impact of Tavapadon on motor function in people with Parkinson’s disease (WPC 2026) - P3 | "Tavapadon-treated participants with baseline motor impairments experienced greater improvements in MDS-UPDRS Parts II/III scores or resolution of PD symptoms compared with placebo-treated participants."

CNS Disorders • Movement Disorders • Parkinson's Disease

Evaluation of daytime sleepiness with Tavapadon in people with Parkinson’s disease (WPC 2026) - P3 | "In the phase 3 studies, tavapadon did not increase daytime sleepiness compared to placebo over 27 weeks. These findings suggest selectively targeting D1/D5 receptors may avoid excessive daytime sleepiness."

CNS Disorders • Excessive Daytime Sleepiness • Movement Disorders • Parkinson's Disease • Sleep Disorder

Impact of Tavapadon on tremor in people with Parkinson’s disease (WPC 2026) - P3 | "This post hoc analysis assessed the impact of tavapadon on tremor, as evaluated by MDS-UPDRS Part II Item 10 (patient experiences of tremor) and Part III Items 15A-18 (clinician-assessed postural tremor, kinetic tremor, rest tremor amplitude, and rest tremor consistency). Tavapadon demonstrated improvements in tremor in people with early PD, based on several tremor-related assessments measured with the MDS-UPDRS."

CNS Disorders • Movement Disorders • Parkinson's Disease

Levodopa initiation or dose modifications in TEMPO-4, a 58-Week Open-Label Trial of Tavapadon in people with Parkinson’s disease (WPC 2026) - P3 | "Approximately 90% of tavapadon-treated participants did not need levodopa initiation or dose increases after a total of 14-20 months of treatment."

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

Investigating the safety and efficacy of long-term administration of Tavapadon in people with Parkinson’s disease (TEMPO-4) (WPC 2026) - P3 | "This interim analysis demonstrated that tavapadon has a favorable long-term safety profile and provides stable efficacy with continued treatment. Selective D1/D5 agonism may offer a differentiated safety profile compared with D2/D3 agonists, as supported by the low rates of AEs of interest."

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

Talk #1 What’s new in PD motor symptom control - new advances and research pipeline (WPC 2026) - "Newer drugs awaiting FDA clearance that have shown promise to also improve on time without dyskinesias are tavapadon, a selective D1/D5 receptor partial agonist, and ND0612, a subcutaneous infusion of levodopa-carbidopa solution. Ongoing Phase 3 trials of Parkinson’s disease drugs designed to improve motor symptoms include CVNB424, a GPR6 receptor modulator, and P2B001, a combination of low doses of extended release rasagiline and pramipexole. While we await disease modifying therapies in Parkinson’s disease, pursuing scientific research of clinical treatments that minimize the impact of motor and non-motor symptoms on quality of life is imperative."

CNS Disorders • Movement Disorders • Parkinson's Disease

Topic #6: What’s New in PD motor symptom control - new advances and research pipel (WPC 2026) - "Newer drugs awaiting FDA clearance that have shown promise to also improve on time without dyskinesias are tavapadon, a selective D1/D5 receptor partial agonist, and ND0612, a subcutaneous infusion of levodopa-carbidopa solution. Ongoing Phase 3 trials of Parkinson’s disease drugs designed to improve motor symptoms include CVNB424, a GPR6 receptor modulator, and P2B001, a combination of low doses of extended release rasagiline and pramipexole. While we await disease modifying therapies in Parkinson’s disease, pursuing scientific research of clinical treatments that minimize the impact of motor and non-motor symptoms on quality of life is imperative."

CNS Disorders • Movement Disorders • Parkinson's Disease

Recent Developments in the Drug Treatment of Parkinson's Disease. (PubMed, Drugs) - "Novel formulations and modes of application include extended-release (ER) oral levodopa (IPX203), levodopa powder for inhalation, and levodopa infusion therapies through subcutaneous (foslevodopa/foscarbidopa, ND0612) or intrajejunal pumps (levodopa [entacapone] carbidopa intestinal gel)...Novel dopamine agonists have been developed and tavapadon, a selective dopamine D1/D5 receptor partial agonist, was shown to be efficacious as monotherapy in early PD and adjunct to levodopa in patients with motor fluctuations. In addition, new data on the early use of the COMT-inhibitor opicapone have emerged. This expanding drug armamentarium is complemented by an increasing number of drugs targeting non-dopaminergic pathways with increasing evidence for amantadine's symptomatic efficacy in treating levodopa-induced dyskinesia and motor fluctuations...PD symptoms can usually be satisfactorily controlled in the early to mid-stages, but the progressive course of the disease..."

Journal • Review • CNS Disorders • Movement Disorders • Parkinson's Disease • COMT • LRRK2

Tavapadon as Adjunctive Treatment for Parkinson Disease: The TEMPO-3 Randomized Clinical Trial. (PubMed, JAMA Neurol) - P3 | "Findings of this randomized clinical trial demonstrate the efficacy, tolerability, and safety profile of tavapadon adjunctive to levodopa for off fluctuations. ClinicalTrials.gov Identifier: NCT04542499."

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

Fixed-Dose Tavapadon for Early Parkinson Disease: A Randomized Clinical Trial. (PubMed, JAMA Neurol) - P3 | "In the TEMPO-1 randomized clinical trial, tavapadon improved motor function in participants with early PD and was well tolerated with a favorable safety profile. ClinicalTrials.gov Identifier: NCT04201093."

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

Levodopa Initiation or Dose Adjustments in TEMPO-4: A 58-Week Open-label Trial of Tavapadon for Treatment of PD (AAN 2026) - P3 | "When modifications were needed, patients were twice as likely to reduce their levodopa dose (∼10%) than to increase it (∼5%), keeping the mean daily dose under 1000 mg. Conclusions After a total of 14-20 months of tavapadon treatment, ~90% of participants did not require levodopa initiation or dose increases."

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

Impact on Tremor in Phase Three Trials of Tavapadon: A Selective D1/D5 Agonist for Treatment of Parkinson’s Disease (AAN 2026) - P3 | "This post hoc analysis evaluated the effects of tavapadon on tremor, as measured by MDS-UPDRS Part II Item 10 (patient experiences of tremor) and Part III Items 15A-18 (clinician-assessed postural tremor, kinetic tremor, rest tremor amplitude, and rest tremor consistency). Most clinician-assessed tremor items (Part III) were significantly improved relative to placebo (TEMPO-1: 5/10 items; TEMPO-2: 7/10 items); items that did not reach significance generally had low baseline scores (ie, median score of 0 or 1). Conclusions People with early PD treated with tavapadon experienced improvements across multiple tremor-related assessments."

CNS Disorders • Movement Disorders • Parkinson's Disease

TEMPO-4 Extension Analysis: Tavapadon Shows Levodopa-Sparing Potential in Parkinson Disease (NeurologyLive) - "In early Parkinson disease entrants from TEMPO-1/2, most participants deferred levodopa initiation over 58–85 weeks while receiving tavapadon...Presented at the 2026 American Academy of Neurology (AAN) Annual Meeting, held April 18-22, in Chicago, Illinois, this post hoc analysis of the TEMPO clinical program indicated that approximately 90% of participants treated with tavapadon over 14 to 20 months did not require initiation or dose increases of levodopa...Safety outcomes were not fully detailed in the abstract, precluding a comprehensive assessment of long-term tolerability."

P3 data • Parkinson's Disease

Tavapadon Improves Motor Function in Early Parkinson’s Disease Trial (EMJ Reviews) - "The TEMPO 1 study was a phase 3, double blind, placebo-controlled randomised clinical trial conducted at 102 sites across 12 countries between December 2019 and June 2024, with a 4-week safety follow up. Of the 751 adults screened, 529 participants with early Parkinson disease were enrolled and randomised 1:1:1 to tavapadon 5 mg n = 177, tavapadon 15 mg n = 177, or placebo n = 175 for 27 weeks. The data showed that the change from baseline to week 26 in the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) parts II and III combined score was significantly improved in participants treated with both the 5-mg dose of tavapadon (−11.5 points; 95% CI, −13.8 to −9.2; P < .001; d = 1.14) and 15-mg dose of tavapadon (−12.1 points; 95% CI, −14.4 to −9.8; P < .001; d = 1.20)."

P3 data • CNS Disorders • Movement Disorders • Parkinson's Disease