TheraRadar
Data updated: Jun 28, 2026

SOLRIAMFETOL HYDROCHLORIDE

Trial Activity: Stable 3 active trials
Approved 2019-03-20
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Duke University conducting 2 trials (33%)
11 indications explored (Broad Platform)
→ excessive daytime sleepiness (2 trials)
→ long covid (2 trials)
→ long covid-19 (2 trials)
1
Indication
--
Phase 3 Trials
7
Years on Market

Details

Status
Prescription
First Approved
2019-03-20
Routes
ORAL
Dosage Forms
TABLET

Companies

ALKEM LABS LTD Hikma
Active Ingredient: SOLRIAMFETOL HYDROCHLORIDE

SOLRIAMFETOL HYDROCHLORIDE Approval History

Original
New Indication
New Form
Label Update
4 FDA actions from 2026 to 2026
Jun 2026 ORIGINAL
Update
FDA Letter

What SOLRIAMFETOL HYDROCHLORIDE Treats

1 FDA approvals

Originally approved for its first indication in 2026 .

  • Other (1)
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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 HYDROCHLORIDE FDA Label Details

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SUNOSI

Full clinical data, patents, trials, and competitive landscape for solriamfetol hydrochloride.

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Data Sources

FDA Approval: ANDA218722 → Trials: ClinicalTrials.gov →

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