Tildrakizumab Approved Naked monospecific

Antibody Information

Entry ID	144
INN	Tildrakizumab
Status	Approved
Drug code(s)	SCH 900222, MK-3222
Brand name	ILUMYA, Ilumetri
mAb sequence source	mAb humanized
General Molecular Category	Naked monospecific
Format, general category	Full length Ab
Format details	None
Isotype (Fc)	IgG1
Light chain isotype	kappa
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	None

Therapeutic information

Target(s)	IL-23p19
Indications of clinical studies	Psoriasis, Ankylosing spondylitis and Non-Radiographic Axial Spondyloarthritis, Psoriatic Arthritis
Primary therapeutic area	Immune-mediated / inflammatory disorders

Development stage information

Phase lengths*

*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).

Most advanced stage of development (global)	Approved EU, US, Japan, Australia
Status	Active
Start of clinical phase (IND filing or first Phase 1)	July 01, 2008
Start of Phase 2	October 15, 2010
Start of Phase 3	December 15, 2012
Date BLA/NDA submitted to FDA	March 23, 2017
Year of first approval (global)	2018
Date of first US approval	March 20, 2018
INN, US product name	Tildrakizumab, Tildrakizumab-asmn
US or EU approved indications	Moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy

Description/comment

None

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None

Company	Merck
Licensee/Partner	Sun, Almirall
Comments about company or candidate	BLA submitted for moderate-to-severe plaque psoriasis. Phase 3 study NCT01722331 started in December 2012; Phase 3 study NCT01729754 started in Feb 2013. July 27, 2016: Sun Pharma and Almirall today announced a licensing agreement on the development and commercialization of tildrakizumab for psoriasis in Europe.
Full address of company	Rahway, NJ 07065 USA North America United States of America https://www.merck.com/contact-us/