APOKYN (apomorphine hydrochloride) · MDD US
APOKYN is FDA-approved to treat 1 condition (same as ONAPGO).
Development Insights
Details
- Status
- Discontinued
- First Approved
- 2004-04-20
- Routes
- SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
APOKYN Approval History
What APOKYN Treats
1 indicationsAPOKYN is approved for 1 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
Same approved indications as ONAPGO (same active ingredient).
MDD US's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02549573 PERFORM results posted | USWM-AP1-4002 | Ph 4 | terminated | Outpatient Physical Therapy Intervention in Subjects With Parkinson's Disease Currently Using APOKYN® |
| NCT01770145 AM IMPAKT results posted | USWM-AP1-4001 | Ph 4 | completed | Apokyn for Motor IMProvement of Morning AKinesia Trial (AM IMPAKT) |
| NCT03292016 results posted | CTH-203 | Ph 2 | completed | A Study That Compares the Extent to Which Apomorphine Becomes Available in the Body After Taking Either an Investigational Drug Containing Apomorphine or Apomorphine That is Injected Under the Skin in People With PD Complicated by "OFF" Episodes |
| NCT02006121 TOLEDO results posted | CT-37527-13-0124 2013-000980-10 | Ph 3 | completed | Clinical Trial of Apomorphine Subcutaneous Infusion in Patients With Advanced Parkinson's Disease |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
APOKYN FDA Label Details
Indications & Usage
FDA Label (PDF)APOKYN is FDA-approved to treat 1 condition — same approved indications as ONAPGO.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment