teplizumab

Phase 3Monoclonal antibody

Sanofi

teplizumab is one of 78 biologic programs targeting Type 1 Diabetes Mellitus. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Type 1 Diabetes MellitusRecruiting

Type 1 DiabetesActive, not recruiting

Type 1 Diabetes MellitusPhase 3

Recruiting

Type 1 DiabetesPhase 3

Active, not recruiting

Competition

Competitive Landscape

79 competitors in Type 1 Diabetes

#DrugCompanyPhaseTrials

Ozempic

Novo Nordisk

Phase 3

6 2

Stelara

Johnson & Johnson

Phase 3

1 3

Inpefa

LLexicon Pharmaceuticals

Phase 3

5 4

Tricor

JJagotec

Phase 3

2 5

Diamox

Teva

Phase 2

2 6

Kerendia

Bayer

Phase 2

1 7

Humira

Novartis

Phase 2

1 8

Prolia

OOrganon and Co

Phase 2

1 9

Bacillus Calmette-Guérin

Bristol-Myers Squibb

Phase 2

1 10

teplizumab

Sanofi

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Active, not recruiting

Type 1 Diabetes

NCT04598893

Recruiting

Type 1 Diabetes

NCT07457580

Q1 2028

Phase 2Recruiting

Type 1 Diabetes Mellitus

NCT06791291

Q4 2028

Phase 3Recruiting

Type 1 Diabetes Mellitus

NCT07088068

Q2 2030

Phase 2Recruiting

Type 1 Diabetes Mellitus

NCT07216391

Clinical

Trials by Indication[1]

Type 1 Diabetes9 trials

Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab

Completed·PProvention Bio, Inc.·Phase 3·NCT03875729·328 enrolled

A Study to Assess the Safety and Tolerability of Different Doses of AG019 Administered Alone or in Combination With Teplizumab in Participants With Recent-onset Diagnosed Type 1 Diabetes (T1D)

Completed·PPrecigen Actobio T1D, LLC·Phase 1/2·NCT03751007·45 enrolled

Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab (PROTECT Extension)

Active, not recruiting·PProvention Bio, a Sanofi Company··NCT04598893·188 enrolled

Show 6 more trials

Description of Patients With Type 1 Diabetes Treated With Teplizumab

Completed· Sanofi logo

Sanofi··NCT06892002·110 enrolled

Teplizumab for Prevention of Type 1 Diabetes In Relatives "At-Risk"

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT01030861·76 enrolled

A Longitudinal, Observational Study Comparing Real-World Experiences of Teplizumab-Treated and Untreated Participants With Stage 2 Type 1 Diabetes in the United States

Recruiting· Sanofi logo

Sanofi··NCT07260110·550 enrolled

Teplizumab in Pediatric Stage 2 Type 1 Diabetes

Active, not recruiting· Sanofi logo

Sanofi·Phase 4·NCT05757713·20 enrolled

A Real-World Retrospective Observational Study Characterizing Patients With Stage 2 Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs)

Recruiting· Sanofi logo

Sanofi··NCT07457580·60 enrolled

Long-Term Outcomes of Participants Treated With Teplizumab in Routine Clinical Care

Recruiting· Sanofi logo

Sanofi··NCT07360080·1,000 enrolled

Type 1 Diabetes Mellitus5 trials

The Protégé Study - Clinical Trial of MGA031 in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

Completed·MMacroGenics·Phase 2/3·NCT00385697·554 enrolled

Protege Encore Study- Clinical Trial of Teplizumab (MGA031) in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

Terminated·MMacroGenics·Phase 3·NCT00920582·254 enrolled

A Randomized, Double-blind, Phase 3 Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Recently Diagnosed Stage 3 Type 1 Diabetes (T1D)

Recruiting· Sanofi logo

Sanofi·Phase 3·NCT07088068·723 enrolled

Show 2 more trials

Adaptive Platform Trial to Delay Progression From Stage 2 to Stage 3 Type 1 Diabetes: Comparing Teplizumab With Low-dose Anti-Thymocyte Globulin (ATG) Protocol TN-40A

Recruiting·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT07216391·60 enrolled

Efficacy and Safety of Teplizumab in the Treatment of Japanese Pediatric and Adult Participants Aged 1 to 34 Years With Stage 2 Type 1 Diabetes: A Multicenter, Randomized, Open-label, Controlled Study.

Recruiting· Sanofi logo

Sanofi·Phase 2·NCT06791291·10 enrolled

Psoriasis1 trial

Safety Study of the Monoclonal Antibody Teplizumab (MGA031) in Subjects With Moderate or More Severe Psoriasis

Terminated·MMacroGenics·Phase 1/2·NCT00954915·1 enrolled

Sources

References

[1]
ClinicalTrials.gov — 15 trial records for teplizumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — teplizumab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for teplizumab. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Sanofi company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: Sanofi

teplizumab

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2028

Q4 2028

Q2 2030

Trials by Indication[1]

Type 1 Diabetes9 trials

Type 1 Diabetes Mellitus5 trials

Psoriasis1 trial

References

Drug Info

Quick Facts

Related News