SOLRIAMFETOL · HETERO LABS LIMITED
Development Insights
Details
- Status
- None (Tentative Approval)
- First Approved
- N/A
- Routes
- N/A
- Dosage Forms
- TABLET
SOLRIAMFETOL Approval History
Clinical Trial Registry
8 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04789174 SHARP results posted | JZP110-405 | Ph 4 | completed | Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study |
| NCT06404099 | Pro00112484_A OTA-21-015G | Ph 2 | completed | RECOVER-SLEEP: Platform Protocol, Appendix_A (Hypersomnia) |
| NCT06404086 | Pro00112484 OTA-21-015G | Ph 2 | completed | RECOVER-SLEEP: Platform Protocol |
| NCT06878976 | SOL-BED-303 | Ph 3 | enrolling by invitation | A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder |
| NCT06170970 SOLARIMS | IRB00295382 | Ph 2 | recruiting | Solriamfetol for the Treatment of Multiple Sclerosis Fatigue |
| NCT06103825 | IGN-B0301-03 | Ph 3 | completed | A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Solriamfetol in the Treatment of Excessive Daytime Sleepiness (EDS) in Patients with Obstructive Sleep Apnea (OSA) |
| NCT06590662 SOLR-IH | RECHMPL23_0432 | Ph 2 | not yet recruiting | Efficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia. |
| NCT07773883 | SOL-ADHD-303 | Ph 3 | enrolling by invitation | An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD |
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.
SOLRIAMFETOL FDA Label Details
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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