TheraRadar
Data updated: Mar 29, 2026

RELYVRIO

SODIUM PHENYLBUTYRATE
Approved 2022-09-29
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
1
Priority Reviews
3
Years on Market

Details

Status
Discontinued
First Approved
2022-09-29
Routes
ORAL
Dosage Forms
FOR SUSPENSION

Companies

AMYLYX
Active Ingredient: SODIUM PHENYLBUTYRATE , TAURURSODIOL

RELYVRIO Approval History

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What RELYVRIO Treats

1 FDA approvals

Originally approved for its first indication in 2022 .

  • Other (1)
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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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.

RELYVRIO FDA Label Details

Pro

RELYVRIO Patents & Exclusivity

Latest Patent: Jul 2040
Exclusivity: Sep 2029

Patents (5 active)

US11583542 Expires Jul 27, 2040
US10857162 Expires Dec 24, 2033
US10251896 Expires Dec 24, 2033
US9872865 Expires Dec 24, 2033
US11071742 Expires Dec 24, 2033

Exclusivity

NCE Until Sep 2027
ODE-411 Until Sep 2029
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA216660 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.