Sodium Phenylbutyrate
Orphan DrugFDA Approved
Description
Sodium phenylbutyrate is a medication used to treat urea cycle disorders. It helps to reduce the amount of ammonia in the blood.
Indications & Therapeutic Use
Urea Cycle Disorders
Global Availability (4 countries)
| Country | Access Route | Regulatory Pathway | Lead Time | Status |
|---|---|---|---|---|
| — | — | — | — | |
| — | — | — | — | |
| — | — | — | — | |
| — | — | — | — |
Available Through
This drug is available for procurement through the following fulfilment partner.
Fulfilment Partner
Sodium Phenylbutyrate
| Generic Name | Sodium Phenylbutyrate |
| Brands | 1 brand available |
| Active Ingredient | Sodium Phenylbutyrate |
| Drug Class | Urea Cycle Disorders |
| Manufacturer | Horizon Therapeutics |
| Dosage Forms | Tablets, Powder |
| Medical Code | A16AX03 |
| Orphan Status | Yes — Orphan Drug |
| Cold Chain | Not Required |
| Reg. Status | FDA Approved |
| Countries | 4 countries |
Authority Signals
Last Verified3/21/2026
Data ConfidenceHigh (AI + Pharmacist)
Source Citations5 Validated Nodes