Is Dulaglutide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 4 valid registrations of Dulaglutide, including TRULICITY 0.75 mg Solution for Injection in Prefilled Pen (0.75 mg, Solution for injection, SAR 362.40); TRULICITY 1.5 mg Solution for Injection in Prefilled Pen (1.5 mg, Solution for injection, SAR 362.40); Trulicity (4.5 mg, Solution for injection in pre-filled pen, SAR 362.40); Trulicity (3 mg, Solution for injection in pre-filled pen, SAR 362.40).

Is Dulaglutide approved by the US FDA?

Drugs@FDA lists 1 application product line for Dulaglutide, including TRULICITY (Prescription).

Is Dulaglutide authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Dulaglutide: Trulicity.

Is Dulaglutide on the WHO Model List of Essential Medicines?

Yes — 18.5.2. Hypoglycaemic agents (core list): Therapeutic equivalent to semaglutide for Type 2 diabetes mellitus.

Are there safety signals or safety updates for Dulaglutide?

EMA PRAC: 7 entries; US FDA: 1 entry (latest 2026-03-12).

Active substance

Dulaglutide

SFDA 4
US FDA 1
EMA 1
Health Canada 2
US price lines 4
NHS prices 4
WHO EML 1
Safety 8

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
TRULICITY 0.75 mg Solution for Injection in Prefilled Pen	0.75 mg	Solution for injection · Subcutaneous use	4 Pre-filled pen	SAR 362.40	Biological · Prescription	Eli Lilly and Company	Valid
TRULICITY 1.5 mg Solution for Injection in Prefilled Pen	1.5 mg	Solution for injection · Subcutaneous use	4 Pre-filled pen	SAR 362.40	Biological · Prescription	Eli Lilly and Company	Valid
Trulicity	4.5 mg	Solution for injection in pre-filled pen · Subcutaneous use	4 Pre-filled pen	SAR 362.40	Biological · Prescription	Eli Lilly and Company	Valid
Trulicity	3 mg	Solution for injection in pre-filled pen · Subcutaneous use	4 Pre-filled pen	SAR 362.40	Biological · Prescription	Eli Lilly and Company	Valid

Indications — CHI Daman Drug Formulary

DIABETES MELLITUS TYPE 2

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

Product	Strength	Form · route	Applicant	Status	First approved
TRULICITY	0.75MG/0.5ML; 1.5MG/0.5ML; 3MG/0.5ML; 4.5MG/0.5ML	injectable · injection	ELI LILLY AND CO	Prescription	18 Sep 2014

EMA European Union — centrally authorised medicines

Trulicity Eli Lilly Nederland B.V. · Authorised · authorised 21 Nov 2014 · ATC A10BJ05

Therapeutic indication (EMA)

Trulicity is indicated for the treatment of patients 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance or contraindications in addition to other medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
TRULICITY	02448599	0.75 MG / 0.5 ML	SOLUTION · SUBCUTANEOUS	ELI LILLY CANADA INC
TRULICITY	02448602	1.5 MG / 0.5 ML	SOLUTION · SUBCUTANEOUS	ELI LILLY CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	TRULICITY 0.75 MG/0.5 ML PEN	$487.57264	per ML	23 Sep 2026
US NADAC	TRULICITY 1.5 MG/0.5 ML PEN	$487.54289	per ML	23 Sep 2026
US NADAC	TRULICITY 3 MG/0.5 ML PEN	$487.5022	per ML	23 Sep 2026
US NADAC	TRULICITY 4.5 MG/0.5 ML PEN	$487.41808	per ML	23 Sep 2026
NHS Drug Tariff	Dulaglutide 0.75mg/0.5ml solution for injection pre-filled disposable devices	£73.25	4 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Dulaglutide 1.5mg/0.5ml solution for injection pre-filled disposable devices	£73.25	4 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Dulaglutide 3mg/0.5ml solution for injection pre-filled disposable devices	£73.25	4 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Dulaglutide 4.5mg/0.5ml solution for injection pre-filled disposable devices	£73.25	4 pre-filled disposable injection	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

18.5.2. Hypoglycaemic agents · core
Therapeutic equivalent to semaglutide for Type 2 diabetes mellitus

Safety signals and safety-related labeling changes

US FDA 12 Mar 2026 TRULICITY — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 14 Jun 2019 PRAC signal: Increased risk of cholangiocarcinoma in adults with type 2 diabetes
Action for MAH: update of the product information: No
EMA PRAC 17 Jan 2019 PRAC signal: Increased risk of cholangiocarcinoma in adults with type 2 diabetes
Action for MAH: update of the product information: No
EMA PRAC 29 Nov 2018 PRAC signal: Diabetic ketoacidosis
Action for MAH: update of the product information: Yes
EMA PRAC 14 Jun 2018 PRAC signal: Diabetic ketoacidosis
Action for MAH: update of the product information: No
EMA PRAC 17 May 2018 PRAC signal: Acute kidney injury
Action for MAH: update of the product information: No
EMA PRAC 11 Jan 2018 PRAC signal: Gastrointestinal stenosis and obstruction
Action for MAH: update of the product information: Yes
EMA PRAC 1 Sep 2017 PRAC signal: Gastrointestinal stenosis and obstruction
Action for MAH: update of the product information: No

All safety entries for dulaglutide →

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.