Risankizumab

Generic Name: Risankizumab

Brand Names: Skyrizi 150 Mg Dose Pack, Skyrizi

Drug Type: Biotech

CAS Number: 1612838-76-2

Unique Ingredient Identifier: 90ZX3Q3FR7

Overview

Risankizumab is a fully humanized IgG1 monoclonal antibody (mAb) directed against interleukin 23 (IL-23). It gained its first global approval in Japan in March 2019, followed by approval in Canada, the US, and Europe in April 2019. Risankizumab is used to treat plaque psoriasis, psoriatic arthritis, and Crohn's disease. Risankizumab is being investigated for atopic dermatitis.

Background

Indication

Risankizumab is indicated to treat:

Associated Conditions

Moderate plaque-type psoriasis
Psoriasis
Psoriatic Arthritis
Severe Plaque Type Psoriasis
Active Psoriatic arthritis
Moderate, active Crohn´s Disease
Moderate, severe Psoriasis Vulgaris (Plaque Psoriasis)
Severe, active Crohn´s Disease

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled Syringe or an On-Body Injector in Healthy Adult Participants	2025/06/05	NCT07007091	Phase 1	Not yet recruiting	AbbVie
A Study to Assess the Bioavailability of Risankizumab Following Subcutaneous Administration With Prefilled Pen Relative to a Prefilled Syringe in Healthy Adult Participants	2025/04/27	NCT06946524	Phase 1	Recruiting	AbbVie
A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administration With On-Body Injector in Healthy Adult Participants	2025/04/22	NCT06937619	Phase 1	Recruiting	AbbVie
A Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab Compared to Vedolizumab	2025/03/18	NCT06880744	Phase 3	Recruiting	AbbVie
Study of Targeted Therapies for the Treatment of Adult Participants With Active Psoriatic Arthritis	2025/03/07	NCT06865105	Phase 2	Recruiting	AbbVie
Evaluation of Sonelokimab in Patients with Active Psoriatic Arthritis and Anti-TNFα Inadequate Response	2024/10/15	NCT06641089	Phase 3	Recruiting	MoonLake Immunotherapeutics AG
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Study Participants With Active Psoriatic Arthritis	2024/10/02	NCT06624228	Phase 3	Recruiting	UCB Biopharma SRL
A Study to Assess the Relative Bioavailability of Two Formulations of Risankizumab Following Subcutaneous Administration With Prefilled Syringes in Healthy Adult Participants	2024/08/26	NCT06571266	Phase 1	Completed	AbbVie
Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease	2024/08/12	NCT06548542	Phase 2	Recruiting	AbbVie
A Study to Assess Pharmacokinetic Exposures Following Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants	2024/07/05	NCT06487572	Phase 1	Completed	AbbVie

FDA Approved Products

Product Name	Manufacturer	Route	Strength	Approved	NDC Code

No FDA products found

No FDA products found for this drug

EMA Approved Products

Product Name	EMA Number	Auth. Holder	Country	Drug Type	Status	Issued	Opinion	Revision
Skyrizi	EMEA/H/C/004759	AbbVie Deutschland GmbH & Co. KG,Knollstrasse,67061 Ludwigshafen,Germany	Germany	N/A	Authorised	2019/04/26	2019/02/28	26

HSA Approved Products

Product Name	Manufacturer	Dosage Form	Strength	Approved	Approval Number
SKYRIZI SOLUTION FOR INJECTION IN PRE-FILLED CARTRIDGE WITH ON-BODY INJECTOR 360MG/2.4ML	Patheon Italia S.P.A. (Bulk Production and Primary Packager)	INJECTION, SOLUTION	360mg/2.4 mL	2023/09/27	SIN16870P
SKYRIZI SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 75MG/0.83ML	Boehringer Ingelheim Pharma GmbH & Co. KG	INJECTION, SOLUTION	75mg/0.83mL	2020/07/06	SIN15972P
SKYRIZI CONCENTRATE FOR SOLUTION FOR INFUSION 600MG/10ML	Patheon Italia S.P.A. (Bulk Production and Primary Packager)	INFUSION, SOLUTION CONCENTRATE	600mg/10mL	2023/09/27	SIN16869P
SKYRIZI SOLUTION FOR INJECTION IN PRE-FILLED PEN 150MG/ML	AbbVie Biotechnology Ltd. (Bulk Production and Primary Packager)	INJECTION, SOLUTION	150mg	2021/10/01	SIN16339P
SKYRIZI SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 150MG/ML	AbbVie Biotechnology Ltd. (Bulk Production and Primary Packager)	INJECTION, SOLUTION	150mg/mL	2021/10/01	SIN16338P

NMPA Approved Products

Product Name	Approval Number	Manufacturer	Dosage Form	Trade Name	Strength	Type	Status	Date	Import

No NMPA products found

No NMPA products found for this drug

PPB Approved Products

Product Name	Registration Code	Company	Category	Sale Type	Registration Date

No PPB products found

No PPB products found for this drug

TGA Approved Products

Product Name	ARTG ID	Sponsor	Status	Registration Date	Ingredient
SKYRIZI risankizumab 150 mg/mL solution for injection pre-filled pen	342814	AbbVie Pty Ltd	Active	2021/08/19	Risankizumab
SKYRIZI risankizumab 600 mg/10 mL concentrate solution for intravenous infusion vial	375984	AbbVie Pty Ltd	Active	2022/10/05	Risankizumab
SKYRIZI risankizumab 75 mg/0.83 mL solution for injection pre-filled syringe	304226	AbbVie Pty Ltd	Active	2019/07/16	Risankizumab
SKYRIZI risankizumab 150 mg/mL solution for injection pre-filled syringe	342813	AbbVie Pty Ltd	Active	2021/08/18	Risankizumab
SKYRIZI risankizumab 360 mg/2.4 mL solution for injection pre-filled cartridge with on-body delivery system	375976	AbbVie Pty Ltd	Active	2022/10/04	Risankizumab
SKYRIZI risankizumab 180 mg/1.2 mL solution for injection pre-filled cartridge with on-body delivery system	427219	AbbVie Pty Ltd	Active	2024/11/15	Risankizumab

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