teplizumab

Trade name: Tzield

mAbapprovedOrphan Drug ^FDABreakthrough Therapy ^FDA

Approved

Nov 17, 2022

Teplizumab, sold under the brand name Tzield, is a humanized anti-CD3 monoclonal antibody that is the first approved treatment indicated to delay the onset of stage 3 type 1 diabetes in people with stage 2 type 1 diabetes. — Wikipedia

Clinical trial activity

25 trials · 26 clinical orgs · 1 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Apr 1, 2000 (NCT00285194)

Timeline

2000s

Jan 1, 2000
Earliest Phase 1 Sponsor(trial)
Jan 1, 2002
Earliest Phase 2 Sponsor(trial)
Sep 29, 2006
Orphan Drug Designation
Jan 1, 2009
Earliest Phase 3 Sponsor(trial)

2020s

Nov 17, 2022
Provention Bio, Inc. — Earliest FDA Approval
Nov 17, 2022
Provention Bio, Inc. — Marketing Organization
Nov 17, 2022
Provention Bio, Inc. — NDA Secondary Org
Nov 17, 2022
Provention Bio, Inc. — NDA Organization

Indications

Approved for

Diabetes Mellitus, Type 1 (approved 2022)

Studied for

Mechanism of action

T-cell surface glycoprotein CD3 epsilon chainOTHER
CD3E other
It binds to an epitope of the CD3-epsilon chain expressed on mature T cells. Modulates the T-cell receptor (TCR)¿CD3 complex resulting in the cells becoming 'blind' to antigen (antigenic immunomodulation of the TCR complex).
- T-cell surface glycoprotein CD3 epsilon chain (CD3E) ↗
T-cell surface glycoprotein CD3 epsilon chainImmunity, passive
CD3E immunity, passive
- T-cell surface glycoprotein CD3 epsilon chain (CD3E) ↗
Tumor necrosis factor receptor superfamily member 17Immunity, passive
TNFRSF17 immunity, passive
- Tumor necrosis factor receptor superfamily member 17 (TNFRSF17) ↗

Approval history

approvedPriority reviewBreakthroughNov 17, 2022

Chemistry & pharmacology

Chirality: Single Stereoisomer
Inorganic: No
Polymer: No
Delivery: Parenteral
Availability: Prescription Only
Multi-specific: No

Oral

Parenteral

Yes

Topical

First in class

Sources

Also known as

anti-cd3 monoclonal antibody
hokt3gamma1
hokt3 gamma 1 (ala-ala)
hokt3gamma1 (ala-ala)
hokt3gamma1(ala-ala)
hokt3γ1
humanized okt3 gamma1(ala-ala)
humanized okt3gamma1(ala-ala)
humanzied okt3
mga031
okt3gamma1 ala-ala, humanized
teplizumab
teplizumab
teplizumab

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT07216391	Phase 2	Dec 1, 2025	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NCT07088068	Phase 3	Aug 6, 2025	Sanofi
NCT06882915	Phase 1	May 1, 2025	Zhejiang University
NCT06791291	Phase 2	Mar 26, 2025	Sanofi
NCT05757713	Phase 4	Jul 25, 2023	Provention Bio, Inc.
NCT05898373	Phase 1/Phase 2 (Phase 2)	Jun 7, 2023	—
NCT05869227	Phase 3	Apr 28, 2023	Southern Medical University, Sun Yat-Sen University
NCT04270942	Phase 2	Mar 31, 2020	Provention Bio, Inc.
NCT04197882	Phase 1	May 27, 2019	Chinese Academy of Medical Sciences
NCT03875729	Phase 3	Apr 5, 2019	Provention Bio, Inc.
NCT03751007	Phase 1/Phase 2 (Phase 2)	Oct 27, 2018	Intrexon, Katholieke Universiteit Leuven, Precigen Actobio, TFS Trial Form Support, Yale University
NCT01459419	Phase 2	Nov 1, 2011	InSpira Medical, Therapix Biosciences Ltd.
NCT01189422	Phase 1	Aug 1, 2010	Eli Lilly, MacroGenics
NCT01030861	Phase 2	Aug 1, 2010	American Diabetes Association, Juvenile Diabetes Research Foundation, National Center for Research Resources (NCRR), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), Type 1 Diabetes TrialNet
NCT00954915	Phase 1/Phase 2 (Phase 2)	Dec 1, 2009	Eli Lilly, MacroGenics
NCT00920582	Phase 3	Sep 1, 2009	Eli Lilly, MacroGenics
NCT00870818	Phase 2/Phase 3 (Phase 3)	Feb 1, 2009	Eli Lilly, MacroGenics
NCT00385697	Phase 2/Phase 3 (Phase 3)	Oct 1, 2006	Eli Lilly, MacroGenics
NCT00378508	Phase 2	Sep 1, 2006	Juvenile Diabetes Research Foundation, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of California, San Francisco, Yale University
NCT00239720	Phase 2	Mar 16, 2006	Immune Tolerance Network, National Institute of Allergy and Infectious Diseases (NIAID), University of Chicago

Showing 20 of 25 trials

Page 1 / 2

Organizations

Research & Development (26)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Eli Lilly	For profit	5	0	3	2006
MacroGenics	For profit	5	5	3	2006
Juvenile Diabetes Research Foundation	Academic/Hospital	4	0	1	2000
National Institute of Allergy and Infectious Diseases (NIAID)	Government	4	3	1	2002
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Government	4	3	2	2003
Yale University	Academic/Hospital	4	1	1	2002
Immune Tolerance Network	Academic/Hospital	3	0	1	2002
Provention Bio, Inc.	For profit	3	3	3	2019
National Center for Research Resources (NCRR)	Government	2	1	1	2001
Sanofi	For profit	2	2	2	2025
American Diabetes Association	Academic/Hospital	1	0	1	2010
Chinese Academy of Medical Sciences	Academic/Hospital	1	1	1	2019
InSpira Medical	Academic/Hospital	1	1	1	2011
Intrexon	For profit	1	1	1	2018
Katholieke Universiteit Leuven	Academic/Hospital	1	0	1	2018
National Institutes of Health (NIH)	Government	1	0	1	2010
Precigen Actobio	For profit	1	0	1	2018
Southern Medical University	Academic/Hospital	1	0	1	2023
Sun Yat-Sen University	Academic/Hospital	1	1	1	2023
TFS Trial Form Support	For profit	1	0	1	2018

26 organizations

Page 1 / 2

Marketing (3)

Organization	Org type	Relationship	Date
Provention Bio, Inc.	For profit	MKTG	Nov 17, 2022
Provention Bio, Inc.	For profit	NDA2	Nov 17, 2022
Provention Bio, Inc.	For profit	NDA	Nov 17, 2022