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

10 Jul 2025·JOURNAL OF MEDICINAL CHEMISTRY

Orally Bioavailable Dopamine D1/D5 Receptor-Biased Agonists to Study the Role of β-Arrestin in Treatment-Related Dyskinesia in Parkinson’s Disease

Article

Author: Dey, Fabian ; Rodríguez Sarmiento, Rosa María ; Vautrelle, Nicolas ; Berchtold, Stefan ; O′Connor, Eoin C. ; Duveau, Venceslas ; Amendola, Davide ; Manevski, Nenad ; Lindemann, Lothar ; Clairfeuille, Thomas

Dopamine replacement therapies for Parkinson's disease often produce dyskinesias with long-term use. Published studies suggest that introducing β-arrestin signaling might be protective for dyskinesia. We advanced known noncatecholamine D1/D5 receptor G protein-biased agonists and found that removal of oxygen in the linker from published compounds limited β-arrestin recruitment, whereas introduction of nitrogen on the central o-phenyl linker favored β-arrestin recruitment and provided orally bioavailable compounds. Cryogenic electron microscopy suggested key receptor-ligand interactions influencing the different bias behaviors. We discovered compound 24, a D1/D5 receptor agonist with β-arrestin recruitment and properties for use in vivo. We compared 24 with tavapadon, which shows weak efficacy for β-arrestin signaling, in a rat model of Parkinson's disease with L-DOPA-induced dyskinesias. At particular doses, compound 24 produced efficacy comparable to L-DOPA, but with fewer concomitant dyskinesias. This first in vivo study suggests that β-arrestin may have a positive influence on reducing dyskinesias following acute administration.

02 Jul 2025·ACS Chemical Neuroscience

Estimation of Dopamine D₁ Receptor Agonist Binding Kinetics Using Time-Resolved Functional Assays: Relation to Agonist-Induced Receptor Internalization by Investigational Antiparkinsonian Therapeutics

Article

Author: Svensson, Peder ; Sahlholm, Kristoffer ; Betari, Nibal ; Malo, Marcus ; Andersson, Daniel R

The dopamine D₁ receptor (D₁R) is prominently expressed in the striatum and cerebral cortex and is an attractive target for treating Parkinson's disease and cognitive impairment in schizophrenia. While newer, noncatechol D₁R agonists such as tavapadon have shown promise in recent clinical trials, the therapeutic utility of earlier catechol agonists such as A77636 was hampered by tolerance development. The mechanism underlying tolerance induction was suggested to involve very slow A77636 dissociation from the D₁R, promoting prominent arrestin recruitment and receptor internalization associated with delayed recycling to the cell surface. Here, we compared the signaling and binding kinetics of five D₁R agonists─dopamine, dihydrexidine, apomorphine, A77636, and tavapadon─using two time-resolved assays of agonist-induced β-arrestin2 recruitment and G protein-coupled inward rectifier potassium (GIRK, also known as Kir3) channel activation, respectively. Additionally, D₁R internalization was studied using cell-surface ELISA. Tavapadon and apomorphine did not induce significant D₁R internalization, whereas pronounced internalization was observed with A77636, dopamine, and dihydrexidine. GIRK response deactivation time courses upon agonist washout were longer for A77636 and tavapadon compared to dopamine, dihydrexidine, and apomorphine. Similarly, in the β-arrestin2 assay, signal decay upon antagonist addition was slower for A77636 and tavapadon compared to the other three agonists. Tavapadon and apomorphine were partial agonists in both assays, whereas A77636 and dihydrexidine showed efficacies similar to dopamine. While our results do not provide evidence for a direct correlation between agonist dissociation and liability to tolerance induction, the possibility remains that certain combinations of agonist characteristics, such as high efficacy paired with slow dissociation, are associated with tolerance induction by D₁R agonists.

20 May 2025·BIOCHEMISTRY

Pharmacological Characterization of Dopamine Receptor DRD1 Variants and Exploration of Their Allosteric Activation

Article

Author: Shao, Zhenhua ; Wu, Chao ; Yang, Zhiqian ; Wang, Kexin ; Shen, Siyuan ; Liu, Zhiyu ; Yan, Wei

G protein-coupled receptors (GPCRs) are major drug targets, yet genetic variations in these receptors can alter drug responses, leading to significant challenges in healthcare. Despite the prevalence of GPCR-targeting drugs, the effects of these genetic variations on receptor function remain underexplored. This study establishes a framework for allosterically rescuing loss-of-function (LoF) variants in GPCRs, using the dopamine receptor D1 (DRD1) as a model. We characterized 49 DRD1 variants from genetic databases and literature, finding that most variants exhibit reduced membrane expression. Structural analysis indicated that variants within the ligand-binding pocket or near critical activation motifs may impair ligand binding or hinder conformational changes during receptor activation, potentially disrupting orthosteric ligand induced signaling. We categorized the variants into three functional groups: those with enhanced G protein signaling, enhanced β-arrestin recruitment, or complete LoF. Among these, 16 variants disrupt G protein signaling, and 27 impair β-arrestin recruitment in HEK293 cells. Notably, defective G protein signaling caused by LoF variants such as T37^1.46K and L66^2.46F were effectively restored using allosteric modulators. These findings highlight the functional impact of DRD1 variants and demonstrate the therapeutic potential of relative selectivity of two signal pathways. This study advances precision medicine by offering strategies to restore receptor function and develop targeted therapies for GPCR-related disorders.

News (Medical) associated with Tavapadon

31 Oct 2025

·www.prnewswire.com

AbbVie Reports Third-Quarter 2025 Financial Results

Reports Third-Quarter Diluted EPS of $0.10 on a GAAP Basis, a Decrease of 88.6 Percent; Adjusted Diluted EPS of $1.86, a Decrease of 38.0 Percent; These Results Include an Unfavorable Impact of $1.50 Per Share Related to Acquired IPR&D and Milestones Expense Delivers Third-Quarter Net Revenues of $15.776 Billion, an Increase of 9.1 Percent on a Reported Basis or 8.4 Percent on an Operational Basis Third -Quarter Global Net Revenues from the Immunology Portfolio Were $7.885 Billion, an Increase of 11.9 Percent on a Reported Basis, or 11.2 Percent on an Operational Basis; Global Skyrizi Net Revenues Were $4.708 Billion; Global Rinvoq Net Revenues Were $2.184 Billion; Global Humira Net Revenues Were $993 Million Third -Quarter Global Net Revenues from the Neuroscience Portfolio Were $2.841 Billion, an Increase of 20.2 Percent on a Reported Basis, or 19.6 Percent on an Operational Basis; Global Vraylar Net Revenues Were $934 Million; Global Botox Therapeutic Net Revenues Were $985 Million; Combined Global Ubrelvy and Qulipta Net Revenues Were $642 Million Third -Quarter Global Net Revenues from the Oncology Portfolio Were $1.682 Billion, a Decrease of 0.3 Percent on a Reported Basis, or 1.3 Percent on an Operational Basis; Global Imbruvica Net Revenues Were $706 Million; Global Venclexta Net Revenues Were $726 Million; Global Elahere Net Revenues Were $170 Million Third -Quarter Global Net Revenues from the Aesthetics Portfolio Were $1.193 Billion, a Decrease of 3.7 Percent on a Reported Basis, or 4.2 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $637 Million; Global Juvederm Net Revenues Were $253 Million Raises 2025 Adjusted Diluted EPS Guidance Range from $10.38 - $10.58 to $10.61 - $10.65, which Includes an Unfavorable Impact of $2.05 Per Share Related to Acquired IPR&D and Milestones Expense Incurred Year-To-Date Through the Third Quarter 2025 Announces 2026 Dividend Increase of 5.5 Percent, Beginning with Dividend Payable in February 2026 NORTH CHICAGO, Ill., Oct. 31, 2025 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced financial results for the third quarter ended September 30, 2025. "AbbVie continues to deliver outstanding results, with significant momentum across key areas of our portfolio. We are also making great progress advancing our pipeline and investing in innovation to support AbbVie's long-term growth," said Robert A. Michael, chairman and chief executive officer, AbbVie. "Based upon the strength of our business and its promising outlook, we are once again raising our quarterly cash dividend." Third -Quarter Results Worldwide net revenues were $15.776 billion, an increase of 9.1 percent on a reported basis, or 8.4 percent on an operational basis. Global net revenues from the immunology portfolio were $7.885 billion, an increase of 11.9 percent on a reported basis, or 11.2 percent on an operational basis. Global Skyrizi net revenues were $4.708 billion, an increase of 46.8 percent on a reported basis, or 46.0 percent on an operational basis. Global Rinvoq net revenues were $2.184 billion, an increase of 35.3 percent on a reported basis, or 34.1 percent on an operational basis. Global Humira net revenues were $993 million, a decrease of 55.4 percent on a reported basis, or 55.7 percent on an operational basis. Global net revenues from the neuroscience portfolio were $2.841 billion, an increase of 20.2 percent on a reported basis, or 19.6 percent on an operational basis. Global Vraylar net revenues were $934 million, an increase of 6.7 percent. Global Botox Therapeutic net revenues were $985 million, an increase of 16.1 percent on a reported basis, or 15.8 percent on an operational basis. Global Ubrelvy net revenues were $354 million, an increase of 31.5 percent. Global Qulipta net revenues were $288 million, an increase of 64.1 percent on a reported basis, or 63.1 percent on an operational basis. Global net revenues from the oncology portfolio were $1.682 billion, a decrease of 0.3 percent on a reported basis, or 1.3 percent on an operational basis. Global Imbruvica net revenues were $706 million, a decrease of 14.8 percent. Global Venclexta net revenues were $726 million, an increase of 7.1 percent on a reported basis, or 4.9 percent on an operational basis. Global Elahere net revenues were $170 million, an increase of 23.3 percent on a reported basis, or 22.4 percent on an operational basis. Global net revenues from the aesthetics portfolio were $1.193 billion, a decrease of 3.7 percent on a reported basis, or 4.2 percent on an operational basis. Global Botox Cosmetic net revenues were $637 million, a decrease of 4.9 percent on a reported basis, or 5.4 percent on an operational basis. Global Juvederm net revenues were $253 million, a decrease of 2.2 percent on a reported basis, or 3.2 percent on an operational basis. On a GAAP basis, gross margin in the third quarter was 66.4 percent. The adjusted gross margin was 83.9 percent. On a GAAP basis, selling, general and administrative (SG&A) expense was 22.6 percent of net revenues. The adjusted SG&A expense was 21.6 percent of net revenues. On a GAAP basis, research and development (R&D) expense was 14.7 percent of net revenues. The adjusted R&D expense was 14.3 percent of net revenues. Acquired IPR&D and milestones expense was 17.0 percent of net revenues. On a GAAP basis, operating margin in the third quarter was 12.1 percent. The adjusted operating margin was 30.9 percent. Net interest expense was $667 million. On a GAAP basis, the tax rate in the quarter was 73.7 percent. The adjusted tax rate was 24.5 percent. Diluted earnings per share (EPS) in the third quarter was $0.10 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $1.86. These results include an unfavorable impact of $1.50 per share related to acquired IPR&D and milestones expense. Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates. Recent Events AbbVie announced the U.S. Food and Drug Administration (FDA) approval of a supplemental New Drug Application (sNDA) that updates the indication statement for Rinvoq (upadacitinib) for the treatment of adults with moderately to severely active ulcerative colitis (UC) and moderately to severely active Crohn's disease (CD). The updated indication statement allows the use of Rinvoq prior to the use of tumor necrosis factor (TNF) blocking agents in patients for whom use of these treatments is clinically inadvisable and who have received at least one approved systemic therapy. AbbVie announced positive topline results from the second of two pivotal studies of the Phase 3 UP-AA clinical program evaluating the safety and efficacy of Rinvoq in adult and adolescent patients with severe alopecia areata (AA). In the study, Rinvoq achieved the primary endpoint, demonstrating that 45.2% and 55.0% of patients with severe AA treated with Rinvoq 15 mg and 30 mg, respectively, reached 80% or more scalp hair coverage at week 24 as defined by the severity of alopecia tool (SALT) score ≤ 20. Key secondary endpoints, including improvements in eyebrows and eyelashes, as well as the percentage of subjects with 90% or more scalp coverage (SALT ≤ 10) and complete scalp hair coverage (SALT=0) at week 24, were also met. Rinvoq's safety profile in AA was generally consistent with that in approved indications, and no new safety signals were identified in this study. AbbVie announced topline results from two replicate Phase 3 studies evaluating the efficacy and safety of Rinvoq 15 mg in adult and adolescent patients living with non-segmental vitiligo (NSV). In the studies, Rinvoq achieved the co-primary endpoints of 50% reduction in total Vitiligo Area Scoring Index (T-VASI 50) from baseline and 75% reduction in Facial Vitiligo Area Scoring Index (F-VASI 75) from baseline at week 48. Additionally, across both studies, statistically significant differences were observed with Rinvoq versus placebo in key ranked secondary endpoints, including F-VASI 50 at week 48. The safety profile of Rinvoq in both studies was generally consistent with that observed in approved indications. AbbVie announced positive topline results from the Phase 3b/4 head-to-head SELECT-SWITCH study evaluating the efficacy and safety of Rinvoq compared to Humira (adalimumab) in adult patients with moderate to severe rheumatoid arthritis (RA), who had an inadequate response or intolerance to a single TNF inhibitor other than Humira. In the study, Rinvoq demonstrated superiority versus Humira in the primary endpoint of achieving low disease activity and demonstrated superiority for additional ranked secondary endpoints at week 12. Rinvoq's safety profile was consistent with previously reported studies, with no new safety risks identified. AbbVie announced that it completed its acquisition of Capstan Therapeutics. The acquisition adds a potential first-in-class in vivo targeted lipid nanoparticle (tLNP) anti-CD19 CAR-T therapy candidate for B cell-mediated autoimmune diseases as well as a proprietary tLNP platform designed to deliver RNA payloads, such as mRNA, capable of engineering specific cell types in vivo. AbbVie announced that it submitted a New Drug Application (NDA) to the FDA for tavapadon, a novel selective dopamine D1/D5 receptor partial agonist for the treatment of Parkinson's disease (PD). The submission is supported by data from the Phase 3 TEMPO program, which demonstrated symptomatic improvement across the PD spectrum. If approved, tavapadon will enhance AbbVie's position in PD by providing patients with a once daily oral treatment option. AbbVie announced positive topline results from the Phase 2 ELATE trial evaluating the safety and efficacy of Botox (onabotulinumtoxinA) for the treatment of upper limb essential tremor. Botox met the primary endpoint in the Phase 2 trial, demonstrating a statistically significant improvement from baseline in the Tremor Disability Scale-Revised (TREDS-R) total unilateral score compared to placebo. The trial also met all six secondary endpoints. Results from safety analyses were generally consistent with the well-established safety profile of Botox. AbbVie announced that it completed its acquisition of Gilgamesh Pharmaceuticals' lead investigational candidate, bretisilocin. Bretisilocin is a novel, short-acting serotonin (5-HT)2A receptor agonist and 5-HT releaser psychedelic compound with best-in-class potential, which is currently in Phase 2 clinical development for the treatment of patients with moderate-to-severe major depressive disorder (MDD). Positive topline results from a Phase 2a study of bretisilocin in MDD were previously announced, demonstrating a clinically impactful and statistically significant reduction in severity of depressive symptoms versus low dose active comparator, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. AbbVie announced submission of a new Biologics License Application (BLA) to the FDA for approval of pivekimab sunirine (PVEK), an investigational antibody-drug conjugate (ADC), for treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN). The submission is based on data from the Phase 1/2 CADENZA trial, a global study evaluating the safety and efficacy of PVEK in BPDCN. BPDCN is a rare and aggressive blood cancer with significant need for innovative treatment options for both newly diagnosed patients and for those whose prior treatments have resulted in relapsed or refractory (R/R) disease. At the European Society for Medical Oncology (ESMO) Congress, AbbVie presented new data from its ADC portfolio in patients with difficult-to-treat tumor types. Highlights included three oral presentations for Temab-A (telisotuzumab adizutecan) as a monotherapy or in combination across advanced, solid tumors, as well as new analysis of ABBV-706 for the treatment of R/R small cell lung cancer (SCLC). At the Society of Hematologic Oncology (SOHO) Annual Meeting, AbbVie announced updated results from the Phase 2 EPCORE NHL-6 trial evaluating the feasibility of dosing and monitoring patients in the outpatient setting for the first full dose of Epkinly (epcoritamab) monotherapy in adult patients with R/R diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line of systemic therapy. Results from the study demonstrated that the incidence and severity of cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) following treatment with epcoritamab were consistent with previous epcoritamab studies in R/R DLBCL. AbbVie announced plans to launch Elahere (mirvetuximab soravtansine-gynx) in the U.K. at a list price equal to the U.S., reflecting the advanced innovation and value of the treatment for adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens. AbbVie is committed to ensuring that developed nations fully recognize the value of our medicines in improving patient outcomes, consistent with the level of recognition in the U.S. Allergan Aesthetics announced several marketing initiatives, which include a new national, multichannel, campaign highlighting Botox Cosmetic's (onabotulinumtoxinA) market leadership, legacy and real-world patient experiences; the launch of a consumer education campaign that is aimed at providing clear, factual information about hyaluronic acid (HA) injectable fillers and the natural-looking results they can achieve; and the launch of SkinVive by Juvederm into 35 new markets. AbbVie announced it broke ground on a $195 million state-of-the-art active pharmaceutical ingredient (API) facility that will manufacture immunology, oncology and neuroscience medicines. This North Chicago, Ill. facility is expected to be fully operational and serving patients by 2027. The company also announced the start of construction on a $70 million expansion at its AbbVie Bioresearch Center (ABC) in Worcester, Mass., which will increase biologics manufacturing for immunology and oncology medicines. These projects are part of AbbVie's previously announced commitment to invest more than $10 billion of capital in the U.S. to broadly support innovation and expand critical manufacturing capabilities and capacity. Full-Year 2025 Outlook AbbVie is raising its adjusted diluted EPS guidance for the full year 2025 from $10.38 - $10.58 to $10.61 - $10.65, which includes an unfavorable impact of $2.05 per share related to acquired IPR&D and milestones expense incurred year-to-date through the third quarter 2025. The company's 2025 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the third quarter of 2025, as both cannot be reliably forecasted. Company Declares Dividend Increase of 5.5 Percent AbbVie is announcing today that its board of directors declared an increase in the company's quarterly cash dividend from $1.64 per share to $1.73 per share beginning with the dividend payable on February 17, 2026 to shareholders of record as of January 16, 2026. This reflects an increase of approximately 5.5 percent, continuing AbbVie's strong commitment to returning cash to shareholders through a growing dividend. Since the company's inception in 2013, AbbVie has increased its quarterly dividend by more than 330 percent. AbbVie is a member of the S&P Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years. About AbbVie AbbVie's mission is to discover and deliver innovative medicines 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: immunology, neuroscience, oncology, and eye care - and products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X (formerly Twitter), Facebook,Instagram, YouTube or LinkedIn. Conference Call AbbVie will host an investor conference call today at 8:00 a.m. Central Time to discuss our third-quarter performance. The call will be webcast through AbbVie's Investor Relations website at investors.abbvie.com. An archived edition of the call will be available after 11:00 a.m. Central Time. Non-GAAP Financial Results Financial results for 2025 and 2024 are presented on both a reported and a non-GAAP basis. Reported results were prepared in accordance with generally accepted accounting principles in the United States (GAAP) and include all revenue and expenses recognized during the period. Non-GAAP results adjust for certain non-cash items and for factors that are unusual or unpredictable, and exclude those costs, expenses, and other specified items presented in the reconciliation tables later in this release. AbbVie's management believes non-GAAP financial measures provide useful information to investors regarding AbbVie's results of operations and assist management, analysts and investors in evaluating the performance of the business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP. 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 2024 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. SOURCE AbbVie WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 2Phase 3Financial StatementAcquisition

31 Oct 2025

·firstwordpharma.com

Skyrizi, Rinvoq continue to fuel AbbVie's immunology surge in Q3

Soaring demand for AbbVie's immunology heavyweights Skyrizi and Rinvoq powered its third-quarter results ahead of forecasts. Together, the two therapies generated roughly half the drugmaker's total quarterly revenue of $15.8 billion, which was up 9.1% year-on-year, company officials said Friday.Skyrizi brought in $4.7 billion during the quarter, a nearly 47% jump from the same time last year, edging past forecasts of roughly $4.5 billion. Rinvoq posted $2.2 billion in sales, up a little over 35% year-over-year and slightly above projections.AbbVie's immunology division overall brought in $7.9 billion, up almost 12%, helping offset the ongoing decline of Humira, which saw sales cut in half to $993 million amid intensifying biosimilar competition. AbbVie has said it expects Skyrizi and Rinvoq to bring in a combined $31 billion in sales by 2027, including $20 billion from Skyrizi and $11 billion from Rinvoq."Investors will continue to monitor the competitive landscape for key indications, such as (inflammatory) bowel disease, but we continue to see Skyrizi and Rinvoq driving strong near-term growth for the company," remarked William Blair analyst Matt Phipps.The neuroscience division posted another strong quarter, with sales climbing about 20% to $2.8 billion. Antipsychotic medicine Vraylar rose 6.7% to $934 million, while migraine treatments Ubrelvy and Qulipta saw sales growing 31.5% and 64.1% to $354 million and $288 million, respectively. Chief Commercial Officer Jeff Stewart also highlighted the "very impressive" launch trajectory of its new Parkinson's disease therapy Vyalev, approved a little over a year ago, which generated $138 million in third-quarter revenue – up 40% on a sequential basis.The oncology portfolio held steady in the third quarter, generating $1.7 billion in revenue, roughly flat year-over-year as gains in newer products offset weakness in older ones. Imbruvica sales were down nearly 15% to $706 million amid rising competition. Elahere, the company's antibody-drug conjugate (ADC) for ovarian cancer, climbed a little over 23% to $170 million, while newer lymphoma drug Epkinly was up around 59% to $69 million.Over the long term, Phipps said "we see potential from the company's Parkinson's disease franchise (Vyalev and tavapadon) as meaningful growth drivers and strong potential from the company's late-stage ADC portfolio (ABBV706 and ABBV400)."Meanwhile, AbbVie boosted its full-year profit outlook, now anticipating adjusted earnings of $10.61 to $10.65 per share, up from a range of $10.38 to $10.58 previously. Analysts project earnings of $10.51 per share and $60.7 billion in sales for the year.

ADCFinancial Statement

26 Sep 2025

·news.abbvie.com

AbbVie Submits New Drug Application to U.S. FDA for Tavapadon for the Treatment of Parkinson's Disease

Neuroscience R&D News Submission supported by data from the Phase 3 TEMPO program that demonstrated symptomatic improvement across the Parkinson's disease spectrum Positive results across all three Phase 3 TEMPO trials reinforce the potential of tavapadon, a novel selective dopamine D1/D5 receptor partial agonist, in Parkinson's disease If approved, tavapadon will enhance AbbVie's leadership in Parkinson's disease by providing patients with a once daily oral treatment option NORTH CHICAGO, Ill., Sept. 26, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tavapadon, a novel selective dopamine D1/D5 receptor partial agonist that was studied as a once daily oral treatment for Parkinson's disease. The submission is based on results from the TEMPO clinical development program that evaluated the efficacy, safety and tolerability of tavapadon across a broad Parkinson's disease population. This includes two Phase 3 trials (TEMPO-1 and TEMPO-2) in early Parkinson's disease, and one Phase 3 trial (TEMPO-3) with tavapadon as adjunctive to levodopa in patients experiencing motor fluctuations. TEMPO-1 and TEMPO-2 demonstrated that patients experienced a statistically significant improvement from baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III combined score at week 26.1 TEMPO-3 demonstrated that patients experienced more "on" time, referring to the period when symptoms were well controlled without dyskinesia or involuntary movements.1 The submission is also based on an interim data cut from TEMPO-4, an open-label extension (OLE) trial to assess the long-term clinical benefit of tavapadon.1 "For many people living with Parkinson's disease, today's oral standard of care isn't effective enough to manage symptoms," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "We recognize the physical and mental impact that Parkinson's disease can cause and are committed to providing next-generation treatment options that will help individuals regain motor control and independence at all stages of this challenging disease." About the TEMPO Clinical Development Program The submission is supported by results from three placebo-controlled studies: TEMPO-1 and -2 enrolled patients with early Parkinson's disease (with or without an MAO-B inhibitor) and TEMPO-3 enrolled patients who are on fixed-dose levodopa and had motor fluctuations. An open-label extension study (TEMPO-4) is ongoing to assess the long-term safety and efficacy of tavapadon through 58 weeks of treatment. TEMPO-4 enrolled patients who completed participation in TEMPO-1 through 3, as well as patients on stable doses of levodopa who had not been in prior TEMPO trials. TEMPO-1 was a Phase 3 double-blind, randomized, placebo-controlled, parallel-group, 27-week trial to evaluate the efficacy, safety and tolerability of two fixed doses of tavapadon in early Parkinson's disease. The primary endpoint was the change from baseline in the MDS-UPDRS Parts II and III combined score. Key secondary endpoints included change from baseline in the MDS-UPDRS Parts II score and percentage of responders with "much improved" or "very much improved" on the Patient Global Impression of Change (PGIC). A total of 529 adults between the ages of 40-80 were enrolled in the trial. All had a confirmed diagnosis of Parkinson's disease and had disease duration (from time of diagnosis) of less than three years. Patients were randomized to receive tavapadon titrated to 5 milligrams, tavapadon titrated to 15 milligrams or placebo, orally and once daily. TEMPO-2 was a Phase 3 double-blind, randomized, placebo-controlled, parallel-group, 27-week trial to evaluate the efficacy, safety and tolerability of flexible doses of tavapadon (5-15 mg QD) in early Parkinson's disease. The primary endpoint was the change from baseline in the MDS-UPDRS Parts II and III combined score. Key secondary endpoints included change from baseline in the MDS-UPDRS Parts II score and percentage of responders with "much improved" or "very much improved" on the PGIC. A total of 304 adults between the ages of 40-80 were enrolled in the trial. All had a confirmed diagnosis of Parkinson's disease and had disease duration (from time of diagnosis) of less than three years. Patients were randomized to receive tavapadon 5-15 mg QD or placebo, orally and once daily. TEMPO-3 was a Phase 3 double-blind, randomized, placebo-controlled, parallel-group, flexible-dose, 27-week trial to evaluate the efficacy, safety and tolerability of tavapadon as an adjunctive therapy to LD for advanced Parkinson's disease. Patients were provided with a home diary to assess their motor function status (Hauser diary). The primary endpoint was change from baseline in the total "on" time without troublesome dyskinesia based on the two-day average of the self-completed Hauser diary. Secondary endpoints included change from baseline in total daily "off" time, change from baseline in total "on" and "off" time at earlier timepoints in the trial, and change from baseline in the MDS-UPDRS Part I, II and III scores. A total of 507 adults between the ages of 40-80 were enrolled in the trial. All had a confirmed diagnosis of Parkinson's disease, were experiencing motor fluctuations and were on a stable dose of LD for at least four weeks prior to screening. Patients were randomized to receive either tavapadon adjunctive to LD, tavapadon titrated to 5-15 milligrams, or placebo and LD, orally and once daily. The majority of adverse events were non-serious and mild or moderate in severity across TEMPO-1 through 3.1 The incidence of SAEs and deaths were low and comparable between placebo and tavapadon groups.1 The most common adverse reactions reported in ≥10% of patients were nausea, headache and dizziness for Parkinson's disease patients without levodopa, and nausea and dyskinesia for patients on adjunctive therapy with levodopa.1 More information on the studies can be found on www.clinicaltrials.gov: TEMPO-1: NCT04201093 TEMPO-2: NCT04223193 TEMPO-3: NCT04542499 TEMPO-4: NCT04760769 About Parkinson's Disease More than 11 million people worldwide are living with Parkinson's disease,2 a progressive and chronic neurological disorder characterized by tremor, muscle rigidity, slowness of movement and difficulty with balance.3 The motor symptoms of Parkinson's disease begin when approximately 60-80 percent of the dopamine-producing cells in the brain are lost, and symptoms continue to worsen slowly over the course of time.4 As Parkinson's disease progresses, patients 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 have more difficulty moving.5 Patients with advanced Parkinson's disease may also experience dyskinesia (involuntary movements) which can significantly hinder daily activities.5 While there is no known cure for the disease, there are treatments available to help reduce symptoms.4 About Tavapadon Tavapadon is an investigational, 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 is not approved by any health regulatory authority. About AbbVie in Neuroscience At AbbVie, our commitment to preserving personhood of people around the world living with neurological and psychiatric disorders is unwavering. With more than three decades of experience in neuroscience, we are providing meaningful treatment options today and advancing innovation for the future. AbbVie's Neuroscience portfolio consists of approved treatments in neurological conditions, including migraine, movement disorders, and psychiatric disorders, along with a robust pipeline of transformative therapies. We have made a strong investment in research and are committed to building a deeper understanding of neurological and psychiatric disorders. Every challenge makes us more determined and drives us to discover and deliver advancements for those impacted by these conditions, their care partners, and clinicians. For more information, visit www.abbvie.com. 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 – immunology, oncology, neuroscience, and eye care — and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @AbbVie on LinkedIn, Facebook, Instagram, X (formerly Twitter) 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 2024 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. Contact(s): U.S. Media: Kayla Azzato +1 (224) 355-5243 Kayla.azzato@abbvie.com Global Media: Amber Landis +1 (231) 557-6596 Amber.landis@abbvie.com Investors: Liz Shea +1 (847) 935-2211 Liz.shea@abbvie.com References 1 AbbVie. Data on file ABVRRTI79943. 2 Statistics. Parkinson's Foundation. Available at: https://www.parkinson.org/understanding-parkinsons/statistics. Accessed August 27, 2025. 3 About Parkinson's: Parkinson's 101. The Michael J. Fox Foundation for Parkinson's Research. Available at: https://www.michaeljfox.org/understanding-parkinsons/i-have-got-what.php. Accessed August 27, 2025. 4 Parkinson's Disease: Hope Through Research. National Institute of Neurological Disorders and Stroke. Available at: https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Hope-Through-Research/Parkinsons-Disease-Hope-Through-Research. Accessed August 27, 2025. 5 "Off" Time in Parkinson's Disease. The Michael J. Fox Foundation for Parkinson's Research. Available at: https://www.michaeljfox.org/time-parkinsons-disease. Accessed August 27, 2025. US-TAV-250006 SOURCE AbbVie

Clinical ResultPhase 3NDADrug Approval

100 Deals associated with Tavapadon

External Link

KEGG	Wiki	ATC	Drug Bank
D11431	Tavapadon	-	DB14899

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Parkinson Disease	NDA/BLA	United States	AbbVie, Inc.	26 Sep 2025
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

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04223193 (TEMPO-2, CTgov)	Phase 3	Parkinson Disease	304	Placebo (Placebo)	knzarjoyfo(drlrptjeei) = qxquoebhim fzeupfwnax (qquxdeqlhk, 0.89) View more	-	21 Nov 2025
				Tavapadon (Tavapadon)	knzarjoyfo(drlrptjeei) = xqzcnweopp fzeupfwnax (qquxdeqlhk, 0.99) View more
NCT04201093 (TEMPO-1, CTgov)	Phase 3	Parkinson Disease	529	Placebo (Placebo)	lmmitqsfcy(auscdkjwzq) = lvfkwukjss utzbkwxykf (ioiecknwrg, 0.82) View more	-	28 Jul 2025
				Tavapadon (Tavapadon 5 mg)	lmmitqsfcy(auscdkjwzq) = hyrkpnsccx utzbkwxykf (ioiecknwrg, 0.86) View more
NCT04542499 (TEMPO-3, CTgov)	Phase 3	Motor Disorders \| Parkinson Disease	507	Placebo (Placebo)	qmtirqsqto(thikjqbzon) = tgvavabapc fekvmrkefp (xsndiohnlg, 0.188) View more	-	25 Mar 2025
				Tavapadon (Tavapadon)	qmtirqsqto(thikjqbzon) = rjxdpyudum fekvmrkefp (xsndiohnlg, 0.207) View more
NCT04223193 (TEMPO-2, Company_Website) Manual	Phase 3	Parkinson Disease	304	Tavapadon	xxlhbvzjgn(nogkenwriu) = gtpjewmdhn hadjcdllxe (wkutuygllk ) Met	Positive	09 Dec 2024
				Placebo	xxlhbvzjgn(nogkenwriu) = empowwtper hadjcdllxe (wkutuygllk ) Met
NCT04201093 (TEMPO-1, NEWS) Manual	Phase 3	Parkinson Disease	-	tavapadon (5 mg/day)	glplozvwea(pillziamyz) = foyrnshmkx ululxnnhgb (vzwafoonud ) Met	Positive	27 Sep 2024
				tavapadon (15 mg/day)	glplozvwea(pillziamyz) = esbelwtred ululxnnhgb (vzwafoonud ) Met
NCT04542499 (TEMPO-3, NEWS) Manual	Phase 3	Parkinson Disease	-	Tavapadon	fpyijuzxmd(xkdybdgnif) = 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. pruyjoqlph (nzklloyyku ) Met View more	Positive	18 Apr 2024
NCT02847650 (Pubmed \| Ther Adv Neurol Disord) Manual	Phase 2	Parkinson Disease	57	PF-06649751	woknrrhuzm(yaisscjdoz) = fsxfakykdr pqmyqxveju (wniqqlidzw, 1.54)	Positive	06 Mar 2020
				Placebo	woknrrhuzm(yaisscjdoz) = nugxnhxspp pqmyqxveju (wniqqlidzw, 1.65)
NCT03185481 (CTgov)	Phase 2	Motor Disorders \| Parkinson Disease	5	PF-06649751	ivsjthbzix = bczycvoiai bdrkmpsugi (tzgucdomrt, jmsholgeiw - dofptihqpg) View more	-	12 Apr 2019
NCT02847650 (CTgov)	Phase 2	Young onset Parkinson disease	57	PF-06649751 (PF-06649751)	tlhfmdbvjj(cydntacnno) = ofcpwahbps yoftsgktkk (gbjumbbcpb, 1.54) View more	-	15 Jan 2019
				Placebo (Placebo)	tlhfmdbvjj(cydntacnno) = bvguqezoan yoftsgktkk (gbjumbbcpb, 1.65) View more
NCT02687542 (CTgov)	Phase 2	Motor Disorders \| Parkinson Disease	108	Placebo	fwujcgtakj(tytkmpovjf) = njsiacnnds gklwdnhgwd (tsvxpptavg, 0.4092) View more	-	24 Dec 2018

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