Is Berotralstat registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Berotralstat, including Orladeyo (150 mg, Capsule, hard, SAR 41530.50).

Is Berotralstat approved by the US FDA?

Drugs@FDA lists 2 application product lines for Berotralstat, including ORLADEYO (Prescription); ORLADEYO (Prescription).

Is Berotralstat authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Berotralstat: Orladeyo.

Are there safety signals or safety updates for Berotralstat?

US FDA: 1 entry (latest 2025-12-23).

Active substance

Berotralstat

SFDA 1
US FDA 2
EMA 1
Health Canada 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Orladeyo	150 mg	Capsule, hard · Oral use	28 Blister	SAR 41530.50	NCE · Prescription	BioCryst Pharmaceuticals, Inc	Valid

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
ORLADEYO	EQ 110MG BASE; EQ 150MG BASE	capsule · oral	BIOCRYST	Prescription	3 Dec 2020
ORLADEYO	EQ 72MG BASE/PACKET; EQ 96MG BASE/PACKET; EQ 108MG BASE/PACKET; EQ 132MG BASE/PACKET	pellets · oral	BIOCRYST	Prescription	11 Dec 2025

EMA European Union — centrally authorised medicines

Orladeyo Neopharmed Gentili Ireland Limited · Authorised · authorised 30 Apr 2021 · ATC B06AC06

Therapeutic indication (EMA)

Orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older weighing at least 40 kg. Orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in: children aged 2 to less than 12 years weighing at least 15 kg adolescents aged 12 and older weighing less than 40 kg

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ORLADEYO	02527693	150 MG	CAPSULE · ORAL	BIOCRYST PHARMACEUTICALS INC

Safety signals and safety-related labeling changes

US FDA 23 Dec 2025 ORLADEYO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for berotralstat →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.