Drugs / FOSLEVODOPA
FOSLEVODOPA
also known as
ABBV-951 · 3-hydroxy-o-phosphono-l-tyrosine · FOSLEVODOPA COMPONENT OF ABBV-951 · Foslevodopa component of vyalev · Foslevodopa/Foscarbidopa · Levodopa-4'-monophosphate
Small molecule targets ADRB1 via activation
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Rejected (CRL) | US (FDA) | — | parkinsonism with polyneuropathy | 2024-06-25 | “U.S. Food and Drug Administration (FDA) issues Complete Response Letter (CRL) for ABBV-951 based on observations from an inspection” abbvie.com ↗ |
| Rejected (CRL) | US (FDA) | — | parkinsonism with polyneuropathy | 2023-03-22 | “today announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for ABBV-951” abbvie.com ↗ “AbbVie announced it received a Complete Response Letter (CRL) from the FDA for the New Drug Application (NDA) for ABBV-951” abbvie.com ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT05094050 | Jan 2022 → Mar 2023 | Parkinson disease | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT03374917 | Apr 2018 → Mar 2019 | Parkinson disease | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT03033498 | May 2017 → Jun 2019 | Parkinson disease | AbbVie | Completed | No outcome recorded |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT04750226 | Feb 2021 → Apr 2026 | Parkinson disease | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT04380142 | Oct 2020 → Sep 2021 | Parkinson disease | AbbVie | Completed | Met primary |
| Phase 3 | NCT03781167 | Apr 2019 → Aug 2022 | Parkinson disease | AbbVie | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2024-10-17 | AbbVie | Regulatory U.S. FDA Approves VYALEV™ (foscarbidopa and foslevodopa) for Adults Living with Advanced Parkinson's Disease abbvie.com ↗
AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved VYALEV™ (foscarbidopa and foslevodopa) as the first and only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of motor fluctuations in adults with advanced Parkinson's disease (PD). |
| 2024-07-25 | AbbVie | Regulatory AbbVie Reports Second-Quarter 2024 Financial Results abbvie.com ↗
AbbVie announced it received a Complete Response Letter (CRL) from the FDA for the New Drug Application (NDA) for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in adults with advanced Parkinson's disease (PD). |
| 2024-06-25 | AbbVie | Regulatory AbbVie Provides U.S. Regulatory Update on ABBV-951 (Foscarbidopa/Foslevodopa) abbvie.com ↗
AbbVie (NYSE: ABBV) today announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in adults with advanced Parkinson's disease. |
| 2023-03-22 | AbbVie | Regulatory AbbVie Provides Regulatory Update on ABBV-951 (Foscarbidopa/Foslevodopa) New Drug Application abbvie.com ↗
AbbVie (NYSE: ABBV) today announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in adults with advanced Parkinson's disease. |
| 2022-05-20 | AbbVie | Regulatory AbbVie Submits New Drug Application to U.S. FDA for Investigational ABBV-951 (Foscarbidopa/Foslevodopa) for the Treatment of Advanced Parkinson's Disease abbvie.com ↗
AbbVie (NYSE: ABBV) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in patients with advanced Parkinson's disease (PD). |
| 2022-03-29 | AbbVie | Results AbbVie to Showcase Breadth of Neuroscience Portfolio and Pipeline at American Academy of Neurology (AAN) 2022 Annual Meeting abbvie.com ↗
Safety and Efficacy of 24-Hour/Day Subcutaneous Infusion of Foslevodopa/Foscarbidopa in Advanced Parkinson's Disease During a Phase 3 Study: 6-Month Interim Results |
| 2021-10-29 | AbbVie | Results AbbVie Reports Third-Quarter 2021 Financial Results abbvie.com ↗
AbbVie announced ABBV-951 (foslevodopa/foscarbidopa) met the primary endpoint in a pivotal Phase 3 trial in patients with advanced Parkinson's Disease (PD). |
| 2021-10-28 | AbbVie | Results AbbVie Announces ABBV-951 (Foslevodopa/Foscarbidopa) Showed Improvement in Controlling Motor Fluctuations Compared to Oral Levodopa/Carbidopa Medication in Pivotal Phase 3 Trial in Patients with Advanced Parkinson's Disease abbvie.com ↗
AbbVie (NYSE: ABBV) today announced that continuous 24 hours/day subcutaneous infusion of ABBV-951 (foslevodopa/foscarbidopa) was statistically superior to oral levodopa/carbidopa in reducing motor fluctuations in patients with advanced Parkinson's disease (PD) in a Phase 3, randomized, double-blind, double-dummy, active-controlled study. |
| 2019-11-01 | AbbVie | Results AbbVie Reports Third-Quarter 2019 Financial Results abbvie.com ↗
Final data from the Phase 1b study evaluating the safety and tolerability of the investigational medicine ABBV-951 in patients with advanced PD demonstrated that ABBV-951 is safe and tolerable |
All press releases naming this drug 11 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | FOSLEVODOPA | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594379 ↗ |
| Known as | 3-hydroxy-o-phosphono-l-tyrosine | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594379 ↗ |
| Known as | ABBV-951 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05094050 ↗ |
| Known as | FOSLEVODOPA COMPONENT OF ABBV-951 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594379 ↗ |
| Known as | Foslevodopa component of vyalev | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594379 ↗ |
| Known as | Foslevodopa/Foscarbidopa | “The purpose of this study was to assess the safety and tolerability of ABBV-951 (Foslevodopa/Foscarbidopa) in participants with Parkinson's disease (PD).” NCT03781167 ↗ |
| Known as | Levodopa-4'-monophosphate | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594379 ↗ |
| Action | Activate | “Beta-1 adrenergic receptor agonist” CHEMBL4594379 ↗ |
| Modality | Small molecule | — CHEMBL4594379 ↗ |
| Route | Subcutaneous | “ABBV-951 administered by subcutaneous infusion.” NCT03033498 ↗ |
| Target | ADRB1 | “Beta-1 adrenergic receptor agonist” CHEMBL4594379 ↗ |