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Juvmo (tavapadon)

Parkinson's disease

Also known as CVL-751
Manufacturer
AbbVie
Regulatory submission
NDA submitted September 2025
Last updated
217 sources

Product information and disease descriptionProduct description

Phase of product development

8 evidence topics · 12 sources

Regulatory submission: NDA submitted September 2025

“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.” (opens the source at this quote in a new tab)

“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.” (opens the source at this quote in a new tab)

“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.” (opens the source at this quote in a new tab)

“In September 2025, AbbVie announced the submission of a New Drug Application (NDA) to the U.S. FDA for tavapadon, a novel selective dopamine D1/D5 receptor partial agonist, for the treatment of Parkinson's disease.” (opens the source at this quote in a new tab)

Launch: Expected by Citi analysts in the third quarter of 2026

“AbbVie did not respond to a Reuters request for comment on the drug’s launch and pricing.” (opens the source at this quote in a new tab)

“Citi analysts had previously said the launch was expected in the third quarter of 2026, but that uptake was likely to be gradual as negotiations progressed on the drug’s Medicare coverage.” (opens the source at this quote in a new tab)

“COMING SOON” (opens the source at this quote in a new tab)

“Learn more right at launch about JUVMO and stay current with product updates when you sign up below.” (opens the source at this quote in a new tab)

FDA approval: September 2026
FieldQuoted record
Drug name“Juvmo”
Active ingredient“tavapadon”
Approval date“9/25/2026”
FDA-approved use on approval date“To treat Parkinson’s disease in adults”

“JUVMO™ (tavapadon) tablets, for oral use” (opens the prescribing information at this quote)

“Initial U.S. Approval: 2026” (opens the prescribing information at this quote)

Planned submission timing stated at the final Phase 3 readout

“AbbVie is on track to submit the New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) in 2025.” (opens the source at this quote in a new tab)

“A New Drug Application (NDA) was submitted to the Food and Drug Administration (FDA) in 2025, with a decision expected in 2026.” (opens the source at this quote in a new tab)

Development history: discovery at Pfizer and transfer to Cerevel Therapeutics

“Pfizer is contributing a portfolio of pre-commercial neuroscience assets to Cerevel, which include three clinical-stage compounds and several pre-clinical compounds designed to target a broad range of CNS disorders including Parkinson’s, Alzheimer’s, epilepsy, schizophrenia and addiction.” (opens the source at this quote in a new tab)

“The most advanced assets in the portfolio are a D1 partial agonist which will likely enter Phase III in 2019 to treat the symptoms of Parkinson’s disease, and a Phase II ready selective GABA 2/3 agonist which will initially be studied for epilepsy.” (opens the source at this quote in a new tab)

“In August 2018, we entered into the Pfizer License Agreement pursuant to which we were granted an exclusive, sublicensable, worldwide license under certain Pfizer patent rights, and a non-exclusive, sublicensable, worldwide license under certain Pfizer know-how, to develop, manufacture and commercialize certain compounds and products” (opens the source at this quote in a new tab)

“We are also required to pay Pfizer tiered royalties on the aggregate net sales during each calendar year, determined on a product-by-product basis with respect to products under the Pfizer License Agreement, at percentages ranging from the low-single digits to mid-teens” (opens the source at this quote in a new tab)

“We initiated a registration-directed Phase 3 program for tavapadon beginning in January 2020, which includes two trials as monotherapy in early-stage Parkinson’s, known as TEMPO-1 and TEMPO-2, one trial as adjunctive therapy in late-stage Parkinson’s, known as TEMPO-3, and an open-label extension trial, known as TEMPO-4.” (opens the source at this quote in a new tab)

“It was initially developed by Pfizer and outlicensed to Cerevel Therapeutics, which was eventually acquired by AbbVie.” (opens the source at this quote in a new tab)

Development history: early-phase trials under Pfizer, including a terminated Phase 2 trial in advanced disease

“While this study suggested that tavapadon was generally well tolerated and provided motor benefit for the treatment of early-stage PD, enrollment was terminated early in this study due to its link to a concurrent phase 2 trial of tavapadon in advanced PD (NCT02687542) that failed to meet a prespecified efficacy threshold in an interim futility analysis” (opens the source at this quote in a new tab)

Development history: acquisition of Cerevel Therapeutics by AbbVie

“AbbVie (NYSE: ABBV) today announced that it has completed its acquisition of Cerevel Therapeutics (NASDAQ: CERE). With the completion of the acquisition, Cerevel is now part of AbbVie.” (opens the source at this quote in a new tab)

“Tavapadon, a first-in-class dopamine D1/D5 selective partial agonist for the management of Parkinson's disease, is currently in Phase 3 studies and has potential for both monotherapy and adjunctive treatment.” (opens the source at this quote in a new tab)

“AbbVie has acquired all outstanding Cerevel common stock for $45 .00 per share.” (opens the source at this quote in a new tab)

Development funding agreements with milestone and royalty repayment on approval

“Under the agreements, Cerevel Therapeutics received funding to support development of tavapadon and agreed to repay regulatory milestones, sales milestones and royalties contingent upon approval of tavapadon by the U.S. FDA.” (opens the source at this quote in a new tab)

“In all circumstances, total repayments under the funding agreements will not exceed $ 531 million in aggregate.” (opens the source at this quote in a new tab)

FDA expedited program designations

No evidence found.