Data updated: May 26, 2026
ADZENYS ER (amphetamine)
CNS
Approved 2017-09-15
1
Indication
--
Phase 3 Trials
8
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2017-09-15
- Patent Cliff
- 2032
- Routes
- ORAL
- Dosage Forms
- SUSPENSION, EXTENDED RELEASE
ADZENYS ER Approval History
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2017 to 2022
What ADZENYS ER Treats
1 FDA approvalsOriginally approved for its first indication in 2017 .
- Other (1)
📋
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03242772 results posted | Pro00085179 1P50HD093074-01 | Ph 2 | terminated | Impact of Combined Medication and Behavioral Treatment for ASD & ADHD |
| NCT02959892 results posted | TAK-041-1002 U1111-1184-1947, 2016-002346-23 | Ph 1 | completed | A Single-Dose Positron Emission Tomography (PET) Study to Determine the Effect of TAK-041 on Amphetamine-Induced Dopamine Release in the Central Nervous System (CNS) |
| NCT02020408 results posted | 090661 R01MH092793 | Ph 4 | completed | Monoamine Contributions to Neurocircuitry in Eating Disorders |
| NCT00733993 results posted | DA09262 P50DA009262, DPMCDA | Ph 1, Ph 2 | completed | Caffeine and Cocaine |
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
|
Loading...
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.
ADZENYS ER FDA Label Details
View full patent landscape →
3 OB patents · 1 families ·
20 international docs across 3 countries
Pro Intelligence Preview
Deep insights for ADZENYS ER
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2032
- • 3 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Unlock Full Intelligence
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.