Drugs / IPX203
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | Parkinson disease | 2024-02-08 | “provided a Complete Response resubmission to the U.S. Food and Drug Administration (FDA) for IPX203” amneal.com ↗ |
| Filed | US (FDA) | — | Parkinson disease | 2022-08-31 | “today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for IPX203” amneal.com ↗ |
| Filed | EU (EMA) | — | Parkinson disease | — | “Zambon submitted IPX203 to the EMA for regulatory approval in June 2025.” zambon.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT03007888 | Nov 2016 → Aug 2017 | Parkinson disease | Impax Laboratories, LLC | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT03877510 | Apr 2019 → Mar 2022 | Parkinson disease | Impax Laboratories, LLC | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2026-08-28 | Zambon SpA | Regulatory Zambon announces European Commission approval of Hopledo® for Adults with Parkinson's Disease and Moderate to Severe Motor Fluctuations zambon.com ↗
Zambon today announced that the European Commission (EC) has granted marketing authorization for Hopledo® (modified-release levodopa/carbidopa) for the treatment of adult patients with Parkinson’s disease and moderate to severe motor fluctuations who have not been sufficiently stabilized with oral levodopa/dopa decarboxylase (DDC) inhibitor-based treatment regimens. |
| 2026-06-29 | Zambon SpA | Regulatory Zambon Announces Positive CHMP Opinion for Hopledo® (IPX203) for Adults with Parkinson’s Disease and Moderate to Severe Motor Fluctuations zambon.com ↗
Zambon today announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a marketing authorization by the European Medicines Agency (EMA) for Hopledo® (modified-release levodopa/carbidopa) for the treatment of adult patients with Parkinson’s disease and moderate to severe motor fluctuations who have not been sufficiently stabilized with oral levodopa/DDC inhibitor-based treatment regimens. |
| 2026-06-29 | Impax Laboratories, LLC | Regulatory Zambon and Amneal Announce Positive CHMP Opinion for Hopledo® (IPX203) for Adults with Parkinson’s Disease and Moderate to Severe Motor Fluctuations amneal.com ↗ |
| 2024-02-08 | Impax Laboratories, LLC | Regulatory Amneal Announces Complete Response Resubmission for IPX203 New Drug Application amneal.com ↗
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced that it has provided a Complete Response resubmission to the U.S. Food and Drug Administration (FDA) for IPX203, a novel, oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules for the treatment of Parkinson’s disease (PD). |
| 2023-08-24 | Impax Laboratories, LLC | Results JAMA Neurology Publishes Phase 3 Study Results Comparing IPX203 to Immediate-Release Carbidopa/Levodopa for Parkinson’s Disease amneal.com ↗
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) today announced that JAMA Neurology has published results from the RISE-PD clinical study assessing the efficacy and safety of IPX203 versus optimized immediate-release carbidopa/levodopa (IR CD/LD) for the treatment of Parkinson’s disease (PD). |
| 2023-07-03 | Impax Laboratories, LLC | Regulatory Amneal Receives U.S. FDA Complete Response Letter for IPX203 amneal.com ↗
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Company’s New Drug Application (NDA) for IPX203 for the treatment of Parkinson’s disease. |
| 2022-11-11 | Impax Laboratories, LLC | Regulatory Amneal Announces U.S. FDA Filing Acceptance of New Drug Application for IPX203 for the Treatment of Parkinson’s Disease amneal.com ↗
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) today announced the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for IPX203 for the treatment of Parkinson’s disease (PD). |
| 2022-08-31 | Impax Laboratories, LLC | Regulatory Amneal Announces Submission of New Drug Application to the U.S. FDA for IPX203 for the Treatment of Parkinson’s Disease amneal.com ↗ |
| 2017-11-09 | Impax Laboratories, LLC | Results Impax Reports Third Quarter 2017 Results amneal.com ↗
Treatment-emergent adverse events (TEAEs) reported in two or more subjects during IPX203 treatment included nausea, dizziness, and dyskinesia. |
| 2016-08-09 | Impax Laboratories, LLC | Results Impax Reports Second Quarter 2016 Financial Results amneal.com ↗
The results of the interim analysis showed that IPX203 exhibited a statistically significant improvement in the reduction of "off" time compared to both immediate-release CD-LD and Rytary. |
All press releases naming this drug 17 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | IPX203 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03877510 ↗ |
| Route | Oral | “oral administration” NCT03877510 ↗ |