Drugs / Crexont
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | CREXONT | — | 2024-08-07 | fda.gov ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT07138560 | Jul 2025 → Dec 2026 expected | Parkinson disease | The Cleveland Clinic | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-06-05 | Impax Laboratories, LLC | Results Amneal Announces Full Study Population Interim Phase 4 ELEVATE-PD Results, Reinforcing Previously Reported Benefits of CREXONT® in Parkinson's Disease amneal.com ↗
After patients switched from prior therapies, treatment with CREXONT delivered meaningful increases in “Good On” time, reductions in “Off” time, and improved motor symptom control. |
| 2026-04-20 | Impax Laboratories, LLC | Results Amneal Announces Additional Positive Interim Phase 4 ELEVATE-PD Results with CREXONT® for Parkinson’s Disease, Including Over 3 More Hours of Daily “Good On” Time When Switching from RYTARY® amneal.com ↗
After patients switched from prior therapies, treatment with CREXONT delivered meaningful increases in “Good On” time, reductions in “Off” time, and improved motor symptom control. |
| 2025-12-05 | Impax Laboratories, LLC | Results Amneal Announces Positive Interim Phase 4 ELEVATE-PD Results With CREXONT® for Parkinson’s Disease amneal.com ↗ |
| 2025-04-07 | Impax Laboratories, LLC | Results Amneal Announces New Data from Phase 3 Study Showing Significant Improvements in Sleep Quality with CREXONT® (Carbidopa and Levodopa) Extended-Release Capsules in Parkinson’s Disease amneal.com ↗
The new analysis showed that patients on CREXONT, compared to IR CD/LD, also experienced statistically significant improvements across all PDSS-2 subdomains, including reduced disturbed sleep (-1.07, p <0.0001), improved nighttime motor symptoms (‑0.62, p <0.0059) and PD symptoms at night (-0.65, p <0.0017). |
| 2024-08-07 | Impax Laboratories, LLC | Regulatory Amneal Receives U.S. FDA Approval for IPX203 for Treatment of Parkinson’s Disease to Be Launched as CREXONT® (Carbidopa and Levodopa) Extended-Release Capsules amneal.com ↗
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved CREXONT ® (carbidopa and levodopa) extended-release capsules for the treatment of Parkinson’s disease (PD). |
All press releases naming this drug 7 releases
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Crexont | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07138560 ↗ |