A Phase 1, Two Part, Randomized, Single and Multiple Dose Crossover Study to Assess the Relative Bioavailability Between Tavapadon Clinical and Commercial Tablets

This study will assess the relative bioavailability of two different Oral formulations of tavapadon in healthy adult participants.

Start Date26 Mar 2025

Sponsor / Collaborator

AbbVie, Inc.

NCT05610189

/ CompletedPhase 1

A Phase 1, Randomized, Multiple-dose, Crossover Trial in Participants With Parkinson's Disease to Evaluate the Clinical Bioequivalence Between Tavapadon Tablets

The primary purpose of the study is to evaluate the bioequivalence (BE) of tavapadon 15 milligram (mg) tablet to 3x5 mg tablets in participants with Parkinson's disease.

Start Date15 Dec 2022

Sponsor / Collaborator

Cerevel Therapeutics LLC

NCT05581823

/ CompletedPhase 1

A Phase 1, Open-label, Fixed-sequence, Crossover Trial to Evaluate the Effects of Cytochrome P450 (CYP) 3A4 Induction by Carbamazepine on the Steady-state Pharmacokinetics of Tavapadon in Healthy Adult Participants

The primary purpose of this study is to evaluate the effect of carbamazepine, a strong CYP3A4 inducer, on the steady-state pharmacokinetics (PK) of tavapadon in healthy adult participants.

Start Date19 Oct 2022

Sponsor / Collaborator

Cerevel Therapeutics LLC

100 Clinical Results associated with Tavapadon

100 Translational Medicine associated with Tavapadon

100 Patents (Medical) associated with Tavapadon

Literatures (Medical) associated with Tavapadon

01 Sep 2026·NEUROLOGICAL SCIENCES

“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”

Review

Author: Mohammad, Anas ; Nadeem, Abdullah ; Hamad, Maaz ; Rashid, Ahmad Akhtar ; Rashid, Akhtar ; Naz, Sabiha ; Malik, Umamah

BACKGROUND:

Selective D1/D5 dopamine receptor partial agonists are proposed to provide motor benefit without the impulse control disorders and somnolence associated with D2/D3 dopamine agonists. With tavapadon under regulatory review, no quantitative synthesis of this drug class exists.

METHODS:

Embase, MEDLINE, PubMed, Scopus and ClinicalTrials.gov were searched from inception to 31 May 2026 for randomised, double-blind, placebo-controlled trials of selective D1/D5 partial agonists in Parkinson's disease (PROSPERO CRD420261347585). Random-effects models (REML) were used. Risk of bias was assessed with RoB 2 and certainty of evidence with GRADE.

RESULTS:

Seven trials (1,540 participants) were included; five entered quantitative synthesis. In early-stage monotherapy, tavapadon improved the combined MDS-UPDRS Parts II and III score by 10.55 points versus placebo (95% CI - 13.11 to - 7.99; two trials). In levodopa-treated patients with motor fluctuations, good ON-time increased by 1.09 h per day (0.57 to 1.61; two trials). Adverse events (RR 1.36, 1.09 to 1.71), nausea (6.38, 3.23 to 12.59), dizziness (3.03, 2.15 to 4.27) and discontinuation due to adverse events (2.72, 1.07 to 6.96) were more frequent with tavapadon. Serious adverse events were not increased (Peto OR 1.13, 0.69 to 1.85). Impulse control disorder (RR 2.02, 0.51 to 8.00; nine events, one trial) and somnolence (1.20, 0.37 to 3.92) were rated at very low certainty. No outcome reached high certainty.

CONCLUSION:

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.

01 Aug 2026·DRUGS

Recent Developments in the Drug Treatment of Parkinson’s Disease

Review

Author: Leiter, Simon ; Mahlknecht, Philipp ; Poewe, Werner

Parkinson's disease (PD) is a common neurodegenerative disorder caused by a spread of misfolded α-synuclein and ascending neuronal degeneration mainly in dopaminergic neurons, leading to progressive nigrostriatal dysfunction and disruption of other pathways. It is clinically defined by its cardinal motor features of bradykinesia, rest tremor and rigidity, which are usually accompanied by a variety of non-motor symptoms. Here we provide a review on recent developments in the pharmacological treatment of PD with a focus on recently approved drugs, new modes of delivery and agents that are in advanced stages of clinical development. Pharmacological dopamine substitution remains the mainstay of symptomatic treatment approaches to control PD motor symptoms. While levodopa is still considered the gold-standard of symptomatic efficacy, its chronic use is associated with the development of response oscillations and drug-induced dyskinesias in a majority of patients. Thus, much effort has been put into developing more continuous ways of levodopa delivery. 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). Additionally, different preparations for subcutaneous and sublingual administration of apomorphine, a dopamine agonist with equivalent efficacy to levodopa, are available for the treatment of PD motor fluctuations. 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. Beyond the approval of different botulinum toxin preparations for the treatment of sialorrhea, efforts to address the plethora of non-motor symptoms of the disease have not translated to novel PD-specific approvals over the last few years. PD symptoms can usually be satisfactorily controlled in the early to mid-stages, but the progressive course of the disease inevitably leads to increasing functional disability underlining the yet unmet need for disease-modifying therapies. While there is currently no conclusive evidence for disease-modifying efficacy on any of the numerous efforts, we summarize recent late-stage clinical trial evidence focusing on glucagon-like peptide 1 (GLP1) agonists, approaches targeting the glucocerebrosidase (GBA) pathway and inhibition of the leucine-rich repeat kinase 2 (LRRK2), as well as α-synuclein based treatments.

01 Aug 2026·LANCET NEUROLOGY

Safety, tolerability, and efficacy of flexible-dose tavapadon for Parkinson's disease (TEMPO-2): a phase 3, randomised, placebo-controlled, double-blind trial

Article

Author: Peckham, Elizabeth ; Boiser, Joey ; Leoni, Matthew ; Fernandez, Hubert H ; Fietzek, Urban M ; Bhatia, Perminder ; Cloud, Leslie ; Tringali, Stacey ; Combs, Cari ; Chang, Ih ; Sanchez, Raymond ; Zadikoff, Cindy ; Molho, Eric ; Tarakad, Arjun ; Matarazzo, Michele

BACKGROUND:

Current dopaminergic therapies for Parkinson's disease carry significant limitations: levodopa can cause long-term motor complications, while D2/D3 receptor-targeting dopamine agonists can produce non-motor adverse effects. Tavapadon is an oral, once-daily, selective D1/D5 agonist that might improve Parkinson's disease motor symptoms. We aimed to evaluate the safety, tolerability and efficacy of flexible-dose tavapadon in people with early-stage Parkinson's disease.

METHODS:

TEMPO-2 was a phase 3, randomised, double-blind, placebo-controlled trial conducted at 75 clinical sites (both hospital or academic and community settings) across 13 countries. Adults aged 40-80 years with early-stage Parkinson's disease (<3 years' disease duration) who were treatment-naive or had less than 3 months of previous dopaminergic treatment were eligible. Participants were randomly assigned 1:1 to flexible-dose tavapadon (5-15 mg) or placebo orally once daily for 27 weeks. The primary endpoint was change from baseline to week 26 in the combined score of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III (reflecting activities of daily living and motor performance). Safety endpoints included adverse events, clinical laboratory values, vital signs, and electrocardiograms. The primary endpoint was assessed in the modified intent-to-treat population (participants who received one dose or more of study drug and had both a baseline and one or more post-baseline MDS-UPDRS assessments) and safety was assessed in the safety analysis set (all participants who received one dose or more of tavapadon or placebo). This study is registered with ClinicalTrials.gov (NCT04223193) and is now complete.

FINDINGS:

Between Jan 6, 2020, and Feb 22, 2024, 473 individuals were screened and 304 were randomly assigned to receive tavapadon 5-15 mg (n=151) or placebo (n=153). The majority of participants were male (169 [56%] of 304 male; 135 [44%] of 304 female), the mean age was 62·9 (SD 9·2) years, and the mean disease duration was 0·86 (0·79) years. 80 (26%) of 304 participants discontinued from the trial (57 [38%] of 151 on tavapadon and 23 [15%] of 153 on placebo), most commonly due to adverse events (42 [14%] of 304; 36 [24%] of 151 on tavapadon and six [4%] of 153 on placebo). The primary endpoint of change from baseline to week 26 in the MDS-UPDRS Parts II and III combined score was significantly improved with tavapadon versus placebo (least squares mean [LSM] decrease of 10·3 [95% CI -12·2 to -8·3] points vs 1·2 [-2·9 to 0·6] points; LSM treatment difference -9·1 [95% CI -11·7 to -6·5]; p<0·0001). Most adverse events were non-serious and mild to moderate in severity. More adverse events were observed with tavapadon than with placebo (115 [76%] of 151 participants vs 84 [55%] of 153 participants). The incidence of adverse events in the tavapadon group was higher during the titration phase (92 [61%] of 151) than during the dose adjustment (44 [37%] of 151) and maintenance (47 [43%] of 151) phases. The most commonly reported adverse events with tavapadon versus placebo (>10% of participants) were nausea (45 [30%] of 151] vs five [3%] of 153), headache (25 [17%] vs eight [5%]), and dizziness (24 [16%] vs five [3%]).

INTERPRETATION:

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.

FUNDING:

AbbVie.

News (Medical) associated with Tavapadon

30 Sep 2026

·www.biopharmadive.com

PhRMA names next CEO; Pierre Fabre takes third swing at Ebvallo approval

Today, a brief rundown of news involving PhRMA and Pierre Fabre Laboratories, as well as updates from Mirum Pharmaceuticals and AbbVie that you may have missed.The pharmaceutical industrys top lobbying group has named a new leader. The Pharmaceutical Research and Manufacturers of America, or PhRMA, said Tuesday that former congressman Eric Cantor will become its next president and CEO effective Nov. 9. Cantor represented Virginia in the U.S. House of Representatives from 2000 to 2014 and was the House majority leader during the final three years of that stint. Cantor also played an important role in the development of the 21st Century Cures Act and campaigned for legislation that established Medicare Part D, the federal program that pays for certain prescription drugs, PhRMA noted. Hell succeed Steve Ubl, who has led PhRMA since 2015 and will continue on as a strategic adviser through Jan. 15.Pierre Fabre Laboratories has resubmitted an approval request for a cell therapy U.S. regulators have rejected twice. Called Ebvallo, the treatment was originally developed by partner Atara Biotherapeutics and has been available in Europe since late 2022 as a treatment for a lethal complication of Epstein-Barr virus infections. The Food and Drug Administration, though, turned Ebvallo back in 2025 due to manufacturing issues. It spurned Ebvallo again in January, sparking claims by Atara that the agency had backpedaled on a previous agreement. Pierre Fabre has since come to terms with the FDA on a new application built around updated data from a single-arm trial as well as information from expanded access programs and commercial use in Europe.An experimental drug Mirum Pharmaceuticals acquired in a buyout last year has succeeded in the first of two Phase 3 trials against chronic hepatitis D infections. According to Mirum, a once-weekly low dose and once-monthly high dose of its prospect brelovitug significantly suppressed levels of the hepatitis D virus in 56% and 45% of treatment recipients, respectively, after 24 weeks. None of those in a third study arm, who had a delayed start to treatment, hit that mark. Mirum obtained brelovitug in a $620 million buyout of startup Bluejay Therapeutics. It could seek a regulatory clearance if a second late-stage trial, which should report results later this year, is also positive.Mirum separately announced on Friday that the FDA approved one of its drugs for the ultra-rare bone disease Fibrodysplasia ossificans progressiva, or FOP. Incyte had already completed pivotal testing of the therapy, zilurgisertib, when it licensed the drug to Mirum in May for $16 million up front. Fridays clearance makes the drug available to adults and children at least 12 years of age with FOP. Itll be sold as Atebrioz and compete for market share with medicines from Regeneron Pharmaceuticals and Ipsen.The FDA on Monday also approved a new AbbVie medication for Parkinsons disease. Called Juvmo and formerly tavapadon AbbVie acquired the treatment in a nearly $9 billion buyout of Cerevel Therapeutics in 2023. It succeeded in testing months after the purchase was announced, enabling AbbVie to recoup some value on a deal the company has partially written off due to other study failures. Juvmo is a first-of-its-kind medicine that precisely targets two different dopamine receptors. In testing, it helped control symptoms as well as reduce the amount of time when the effects of other medications stop working. '

Phase 3Drug ApprovalAcquisitionExecutive ChangeClinical Result

29 Sep 2026

·firstwordpharma.com

AbbVie's Cerevel-sourced partial dopamine agonist wins US nod for Parkinson's

The FDA on Friday approved AbbVie's Juvmo (tavapadon) to treat adults with Parkinson's disease, according to a listing on the agency's approvals database. The pharma gained the D1/D5 partial agonist through its $8.7-billion takeout of Cerevel Therapeutics, announced in late 2023. However, the centrepiece of that deal, experimental schizophrenia treatment emraclidine, failed in mid-stage testing shortly after the acquisition closed (see – Spotlight On: Three things to watch at AbbVie). Despite the setback, AbbVie has continued to invest in the neurology space, including psychedelics through its purchase last year of Gilgamesh Pharmaceuticals (see – Spotlight On: AbbVie adds to string of big neuro bets). The approval was backed by a trio of Phase III successes for Juvmo. AbbVie reported in late 2024 that the candidate met its primary endpoint of significantly improving motor function in the TEMPO-2 study, which recruited 304 adults with a confirmed Parkinson's diagnosis for less than three years. At week 26, patients treated with a flexible, oral tavapadon dose of 5-15 mg once daily experienced a reduction of 10.3 points from baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III combined score, compared with a 1.2-point drop for placebo. Juvmo also notched wins in TEMPO-1, another monotherapy trial, as well as TEMPO-3, which evaluated the candidate as an adjunctive therapy in levodopa-treated adults. According to the drugmaker's RxAbbVie site, Juvmo's label includes warnings for hypotension, compulsive behaviors, hallucinations and psychotic-like behaviour, as well as dyskinesia. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultAcquisitionDrug Approval

28 Sep 2026

·www.prnewswire.com

U.S. FDA Approves AbbVie's JUVMO™ (tavapadon) for Parkinson's Disease

JUVMO™ is the first and only selective D1/D5 receptor agonist approved for adults with Parkinson's disease1 Taken once daily with or without levodopa therapy, JUVMO offers patients a differentiated approach to motor symptom control across the Parkinson's disease continuum Approval is supported by the Phase 3 TEMPO program demonstrating significant improvements in daily functioning, increased "on" time without troublesome dyskinesia and a favorable safety profile NORTH CHICAGO, Ill., Sept. 28, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved JUVMO™ (tavapadon) tablets as the first and only selective D1/D5 receptor agonist for the treatment of adults with Parkinson's disease, a progressive neurological disorder that affects millions of people worldwide. JUVMO Is a New Kind of Treatment for Parkinson's Disease "The approval of JUVMO marks the first dopaminergic breakthrough for Parkinson's disease in decades," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "People living with Parkinson's and the clinicians who care for them have long faced difficult tradeoffs between motor control, treatment burden and tolerability. Clinicians now have a new treatment option that targets dopamine pathways differently and reduces the difficult tradeoffs associated with D2/D3 selective dopamine agonists." Needed Innovation in the Parkinson's Disease Treatment Landscape For people living with Parkinson's disease, maintaining consistent control of motor symptoms becomes increasingly challenging as the disease progresses. Oral levodopa remains the foundation of treatment and is often effective at controlling symptoms, but many patients require higher and more frequent doses over time. These adjustments can help restore symptom control yet may also contribute to treatment-related complications such as dyskinesia. About 70% of people living with Parkinson's disease have their oral levodopa dose increased within the first year of therapy.2 These challenges highlight the need for new treatment approaches that can help address the evolving needs of people living with Parkinson's disease. After 85 weeks on JUVMO, 93% of clinical trial participants had not increased their oral levodopa dose and 94% of participants with early Parkinson's disease had not started oral levodopa.3 Dopamine agonists have long been used to help manage symptoms and reduce reliance on oral levodopa escalation. However, currently available dopamine agonists primarily target D2/D3 receptors and their use may be limited by tolerability concerns. JUVMO introduces a different approach, selectively targeting D1/D5 receptors to provide health care providers and patients with a new option for managing motor symptoms across the Parkinson's disease continuum. Why the Approval of JUVMO Matters for People across the Spectrum of the Disease "Parkinson's disease treatment has long required health care providers to balance the need for dependable motor symptom control with considerations around treatment tolerability," said Hubert Fernandez, M.D., professor of neurology at the Cleveland Clinic Lerner College of Medicine and global principal TEMPO trial investigator. "Now we have a novel therapy that selectively targets D1/D5 receptors, which addresses a longstanding need for innovation and provides health care providers with greater flexibility to tailor treatment to individual patient needs." Perspective from the Parkinson's Community "For people with Parkinson's and their families, progress means having treatment options that deliver meaningful benefit in everyday life," said Brian Fiske, PhD, chief scientist of The Michael J. Fox Foundation for Parkinson's Research. "Each therapy approval is an important milestone in building a diverse treatment pipeline needed to meet the full range of unmet needs across the Parkinson's community." AbbVie expects to make JUVMO available to patients in the U.S. in October 2026. FDA Approval Was Supported by Phase 3 TEMPO Clinical Trial Data Phase 3 data from the TEMPO clinical trial program demonstrated the efficacy and safety of JUVMO in people with early Parkinson's disease who were not taking oral levodopa (TEMPO-1 and 2) and as an adjunct to oral levodopa in people with Parkinson's disease experiencing motor fluctuations (TEMPO-3).1 In TEMPO-1 at week 26, JUVMO significantly improved activities of daily living scores versus placebo, as measured by MDS-UPDRS Part II, which includes everyday tasks like dressing, eating and personal hygiene (placebo: +0.9; 5 mg: -1.6; 15 mg: -1.7; p <0.0001 each dose versus placebo).1 Compared to baseline, JUVMO improved activities of daily living scores by 22-23% whereas the placebo group worsened by 12%. Additionally, JUVMO significantly improved activities of daily living and motor skills, as measured by MDS-UPDRS Part II + III combined scores, versus placebo (placebo: +1.8; 5 mg: -9.7; 15 mg: -10.2; p <0.0001 each dose versus placebo) at week 26.4 JUVMO also significantly improved MDS-UPDRS Part II scores versus placebo in TEMPO-2 at week 26 (placebo: 0.0; 5-15 mg: -1.5; p =0.0007).1 JUVMO also significantly improved MDS-UPDRS Part II + III combined scores versus placebo in TEMPO-2 at week 26 (placebo: -1.2; 5-15mg: -10.3; p <0.0001).5 In TEMPO-3 at week 26, JUVMO 5-15 mg + oral levodopa significantly increased total daily "on" time without troublesome dyskinesia versus placebo + oral levodopa (1.7 hours versus 0.6 hours, p <0.0001).1 Total daily "off" time decreased by 1.9 hours with JUVMO + oral levodopa, compared to a decrease of 0.9 hours with placebo + oral levodopa (p =0.0006). Sustained efficacy was observed out to 85 weeks for those who continued in the open-label extension period (TEMPO-4).3 Of those on JUVMO + oral levodopa for 85 weeks, 93% did not increase their oral levodopa dose (96/103). Of those on JUVMO without levodopa, 94% did not initiate levodopa (257/273).3 The majority of treatment-emergent adverse events (TEAEs) were non-serious and mild or moderate in severity.1 The most common TEAEs for JUVMO without oral levodopa, reported in ≥5% of patients, were nausea, headache, dizziness, fatigue, dysgeusia, vomiting, dry mouth and anxiety. For JUVMO + oral levodopa, the most common TEAEs, reported in ≥5% of patients, were nausea, dyskinesia, dizziness, headache, hallucinations and orthostatic hypotension. About Parkinson's Disease More than 11 million people worldwide are living with Parkinson's disease,6 a progressive and chronic neurological disorder characterized by tremor, muscle rigidity, slowness of movement and difficulty with balance.7 The motor symptoms of Parkinson's disease begin when approximately 60-80% of the dopamine-producing cells in the brain are lost and symptoms continue to worsen slowly over the course of time.8 As Parkinson's disease progresses, patients may experience complications, including motor and non-motor fluctuations and dyskinesia. Patients report switching from an "on" state (when symptoms are generally well controlled) to an "off" state, during which symptoms such as tremor and stiffness may reappear and patients may have more difficulty moving.9 Patients with later-stage Parkinson's disease may also experience dyskinesia (involuntary movements), which can significantly hinder daily activities.9 USE JUVMO is a prescription medicine used for the treatment of Parkinson's disease in adults. It is not known if JUVMO is safe and effective in children. IMPORTANT SAFETY INFORMATION Tell your healthcare provider about all your medical conditions and all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements, as JUVMO (tavapadon) and certain other medicines may affect each other and how they work. JUVMO may cause serious side effects. Talk to your healthcare provider before starting JUVMO and while on JUVMO if you have had or have any of the following: Lo w blood pr essure. This is a common side effect and may be serious. JUVMO can lower your blood pressure and make you feel dizzy, especially when you stand up (orthostatic hypotension). Do not get up too fast from sitting or after lying down. You may be more likely to feel dizzy after starting JUVMO or when your dose is increased. Unusual urges. Some people taking medicines for Parkinson's disease, including JUVMO, have had unusual urges. This may include gambling, compulsive eating, compulsive shopping, and increased sex drive. Seeing, hearing, or feeling things that are not real (hallucinations). This is a common side effect and may be serious. Tell your healthcare provider if you have a mental health problem such as hallucinations. Uncontrolled sudden movements (dyskinesia). This is a common side effect and may be serious. If you have new dyskinesia or your dyskinesia gets worse, tell your healthcare provider. This may be a sign that your dose of JUVMO or other Parkinson's medicines may need to be adjusted. The most common side effects of JUVMO include nausea, headache, change in taste, feeling tired (fatigue), vomiting, dry mouth, and anxiety. These are not all the possible side effects of JUVMO. For more information, ask your healthcare provider or pharmacist. JUVMO tablet for oral use is available as 5 mg, 10 mg, and 15 mg tablets, as well as 0.25 mg and 1 mg tablets contained in a Titration Pack. Please see the full Prescribing Information, including Patient Information. Talk to your healthcare provider if you have questions. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/PatientAccessSupport to learn more. About AbbVie in Neuroscience At AbbVie, we believe people and their care partners living with difficult-to-treat nervous system disorders deserve more, and that purpose fuels our relentless drive to discover breakthrough science and deliver innovative medicines. We are helping to shape the future of neuroscience with a diverse portfolio of approved and investigational treatments designed to address some of the greatest burdens and unmet needs across psychiatry, migraine and pain, movement disorders and neurodegeneration. Our neuroscience therapies are making a meaningful impact for people around the world today, and our continued research reflects our commitment to exploring new approaches that have the potential to advance standards of care and create possibilities for patients living with these challenging conditions. Discover more at . About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. References JUVMO [package insert]. North Chicago, IL: AbbVie Inc. AbbVie. Data on file: H26.DoF.043. AbbVie. Data on file: ABVRRTI83605. Pahwa R, Moro E, Espay AJ, et al. Fixed-dose tavapadon for early Parkinson disease: a randomized clinical trial. JAMA Neurol. 2026;83(5):452-460. doi:10.1001/jamaneurol.2026.0590 Fernandez HH, Bhatia P, Cloud L, et al. Safety, tolerability, and efficacy of flexible-dose tavapadon for Parkinson's disease (TEMPO-2): a phase 3, randomised, placebo-controlled, double-blind trial. Lancet Neurol. 2026;25(8):721-730. doi:10.1016/S1474-4422(26)00215-2 Luo Y, et al. Global, regional, national epidemiology and trends of Parkinson's disease from 1990 to 2021: findings from the Global Burden of Disease Study 2021. Frontiers in Aging Neuroscience. 2025 Jan 10;16:1498756. About Parkinson's: Parkinson's 101. The Michael J. Fox Foundation for Parkinson's Research. Available at: . Accessed June 17, 2026. Parkinson's Disease: Hope Through Research. National Institute of Neurological Disorders and Stroke. Available at: . Accessed June 17, 2026. Freitas ME, Hess CW, Fox SH. Motor complications of dopaminergic medications in Parkinson's disease. Semin Neurol. 2017 Apr;37(2):147-157. doi: 10.1055/s-0037-1602423 SOURCE AbbVie 21% more press release views with Request a Demo

Phase 3Drug ApprovalClinical Result

100 Deals associated with Tavapadon

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KEGG	Wiki	ATC	Drug Bank
D11431	Tavapadon	-	DB14899

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Parkinson Disease	United States	AbbVie, Inc.	25 Sep 2026

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Motor Disorders	Phase 3	United States	AbbVie, Inc.	23 Sep 2020
Motor Disorders	Phase 3	Australia	AbbVie, Inc.	23 Sep 2020
Motor Disorders	Phase 3	Bulgaria	AbbVie, Inc.	23 Sep 2020
Motor Disorders	Phase 3	Canada	AbbVie, Inc.	23 Sep 2020
Motor Disorders	Phase 3	Czechia	AbbVie, Inc.	23 Sep 2020
Motor Disorders	Phase 3	France	AbbVie, Inc.	23 Sep 2020
Motor Disorders	Phase 3	Germany	AbbVie, Inc.	23 Sep 2020
Motor Disorders	Phase 3	Hungary	AbbVie, Inc.	23 Sep 2020
Motor Disorders	Phase 3	Israel	AbbVie, Inc.	23 Sep 2020
Motor Disorders	Phase 3	Italy	AbbVie, Inc.	23 Sep 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04542499 (Pubmed \| JAMA Neurol)	Phase 3	Parkinson Disease	507	Tavapadon	nfdnvipitn(uihvcefpfa) = yibzwgvhnq clcscaadcb (ugxehdctct ) View more	Positive	01 May 2026
				Placebo	nfdnvipitn(iqqonykeyo) = uqehxtjsvc cmpnzjepfl (toobycavgx ) View more
NCT04760769 (TEMPO-4, AAN2026)	Phase 3	Parkinson Disease	337	Tavapadon	dlwrppilry(jlcazyzmvq) = mhnqmlhzfx thovhnjigj (sjxqzqtqsn )	Positive	25 Apr 2026
				Tavapadon+Levodopa	dlwrppilry(jlcazyzmvq) = xsdhrxxvqc thovhnjigj (sjxqzqtqsn ) View more
NCT04201093 (TEMPO-1, AAN2026)	Phase 3	Parkinson Disease	833	Tavapadon	ehxsovrzwh(jotvldpffo) = olgoedzews gkckeowxmk (lydtuybskw ) View more	Positive	25 Apr 2026
				Placebo	ehxsovrzwh(jotvldpffo) = ddnrlxswyu gkckeowxmk (lydtuybskw ) View more
NCT04223193 (TEMPO-2, CTgov)	Phase 3	Parkinson Disease	304	Placebo (Placebo)	zcaeqdesiu(tzitqxsbcx) = pwnsbjkrxb hpauwwfvfy (cfgafxyote, 0.89) View more	-	21 Nov 2025
				Tavapadon (Tavapadon)	zcaeqdesiu(tzitqxsbcx) = ypdzakcxcw hpauwwfvfy (cfgafxyote, 0.99) View more
NCT04201093 (TEMPO-1, CTgov)	Phase 3	Parkinson Disease	529	Placebo (Placebo)	tdggowurlv(gtbhtiscyj) = kmeolakkky krhkcotswg (tvjqewhofg, 0.82) View more	-	28 Jul 2025
				Tavapadon (Tavapadon 5 mg)	tdggowurlv(gtbhtiscyj) = bjwtanbrhc krhkcotswg (tvjqewhofg, 0.86) View more
NCT04542499 (TEMPO-3, CTgov)	Phase 3	Motor Disorders \| Parkinson Disease	507	Placebo (Placebo)	fsbuxvspim(ggogqcuues) = yjnjhsaawy yjmbsumllk (wuzgluldip, 0.188) View more	-	25 Mar 2025
				Tavapadon (Tavapadon)	fsbuxvspim(ggogqcuues) = xwuhabqvwa yjmbsumllk (wuzgluldip, 0.207) View more
NCT04223193 (TEMPO-2, Company_Website) Manual	Phase 3	Parkinson Disease	304	Tavapadon	glavdmarxc(xfitkphdsb) = kohrepznwj mebjhqfavu (vtcgmfutoo ) Met	Positive	09 Dec 2024
				Placebo	glavdmarxc(xfitkphdsb) = werdtdkivr mebjhqfavu (vtcgmfutoo ) Met
NCT04201093 (TEMPO-1, NEWS) Manual	Phase 3	Parkinson Disease	-	tavapadon (5 mg/day)	absjluzans(mtlaxzindk) = lqoonaecdp cguvxinmuo (rxzzvhxoqy ) Met	Positive	27 Sep 2024
				tavapadon (15 mg/day)	absjluzans(mtlaxzindk) = bvcxatbwbt cguvxinmuo (rxzzvhxoqy ) Met
NCT04542499 (TEMPO-3, NEWS) Manual	Phase 3	Parkinson Disease	-	Tavapadon	xiiczwhgjv(ljjctptcko) = Patients treated with tavapadon adjunctive to LD experienced a clinically meaningful increase of 1.1 hours in total “on” time without troublesome dyskinesia compared to those treated with LD and placebo. mywxzkteuo (qshcmebrko ) Met View more	Positive	18 Apr 2024
NCT02847650 (Pubmed \| Ther Adv Neurol Disord) Manual	Phase 2	Parkinson Disease	57	PF-06649751	sekhlbiubb(stsjfskbpk) = titbccynfv zmyrvpgxcc (xysvpqkpye, 1.54)	Positive	06 Mar 2020
				Placebo	sekhlbiubb(stsjfskbpk) = cgbsfptbqn zmyrvpgxcc (xysvpqkpye, 1.65)

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