Glycerol Phenylbutyrate · Regulatory approval

FDA approval: Glycerol Phenylbutyrate

U.S. Food and Drug Administration · April 30, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

The FDA approved glycerol phenylbutyrate 1.1 g/mL oral liquid formulation (ANDA 207694) on 30 April 2026 as a sponsor (Lupin) original application. This regulatory action record does not contain clinical trial results, efficacy data, or comparative benefit information.

What was studied

Regulatory approval. Intervention: Glycerol phenylbutyrate 1.1 g/mL, liquid, oral formulation.

Key findings

Approval date: 30 April 2026 Formulation: liquid, oral, 1.1 g/mL concentration Application type: original (ORIG)

Safety

This is a regulatory action record and does not report clinical trial results, efficacy endpoints, or safety data. Approved indication(s), dosing recommendations, and safety profile are not stated in this record.

Who this may help

This record indicates regulatory authorization of the product but does not contain information on clinical efficacy, safety profile, or approved indications. Clinicians should consult the approved label and clinical data from the approval dossier for evidence of benefit.

Plain-language summary

FDA approval of glycerol phenylbutyrate oral liquid formulation; this is a regulatory action record without clinical trial data and does not establish efficacy or comparative benefit.

Study design

As stated by the source record.

InterventionGlycerol phenylbutyrate 1.1 g/mL, liquid, oral formulation

Reported figures

Quoted from the source exactly as published.

Approval status date2026-04-30

Clinical bottom line

Caveats

This is a regulatory action record and does not report clinical trial results, efficacy endpoints, or safety data.
Approved indication(s), dosing recommendations, and safety profile are not stated in this record.
No comparator study, control arm, or comparative effectiveness data are provided.
Sample size, study design, and population characteristics from supporting evidence are not included in this record.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

insufficient

This is a regulatory action, not a clinical study.

Directness

insufficient

Record does not report clinical outcomes or trial results.

Consistency

insufficient

No comparative data or consistency assessment provided.

Risk of bias

insufficient

Regulatory record does not assess or report bias metrics.

Sample adequacy

insufficient

No study population or sample size reported in this record.

Source abstract

Drugs@FDA record for application ANDA207694. This is a regulatory action record, not a clinical study. Brand name: GLYCEROL PHENYLBUTYRATE. Active ingredient: GLYCEROL PHENYLBUTYRATE. Sponsor: LUPIN. Submission type: ORIG (original application). Approval status date: 2026-04-30. Products: GLYCEROL PHENYLBUTYRATE, LIQUID, ORAL, GLYCEROL PHENYLBUTYRATE 1.1GM/ML.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

LupinGlycerol Phenylbutyrate