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  1. pharmadog
  2. ›drugs
  3. ›Tzield
drug · antibody
save

teplizumab

pre_registrationupdated 3mo ago
by $SNY Sanofi🔗 ChEMBL
community read0 votes

🐶 often sniffed alongside

top 6
  • tagType 1 Diabetes2 co-mentions · 1 sources
  • tagType 2 Diabetes2 co-mentions · 1 sources
  • company$SNYSanofi1 co-mentions · 1 sources
  • company$SNYNFSanofi1 co-mentions · 1 sources
  • tagEndocrinology & Metabolism1 co-mentions · 1 sources
  • tagPDUFA1 co-mentions · 1 sources

Antibody drug with a maximum clinical stage of Approval (across all indications), with an approval for type 1 diabetes mellitus and 3 investigational indications.

targets

T-cell surface glycoprotein CD3 epsilon chain

all catalysts(1)

pdufa · 1
Apr 29, 2026
pdufa
$SNY43.72-0.14%
4mo ago
Sanofi — teplizumab (PDUFA)
teplizumab
→

Trials studying teplizumab

  • phase3A Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Stage 3 Type 1 Diabetesrecruitingn=723
  • —Long-Term Outcomes of Teplizumab in Routine Clinical Carerecruitingn=1,000
  • —Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs)recruitingn=60
  • —Registry for Stage 2 Type 1 Diabetesrecruitingn=200
  • phase2Efficacy and Safety of Teplizumab in Japanese Participants With Stage 2 Type 1 Diabetesrecruitingn=10
  • phase4Teplizumab in Pediatric Stage 2 Type 1 Diabetesactive not recruitingn=20
  • —Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab (PROTECT Extension)active not recruitingn=188
  • —A Longitudinal, Observational Study Comparing Real-World Experiences of Teplizumab-Treated and Untreated Participants With Stage 2 Type 1 Diabetes in the United Statesrecruitingn=550
more trials →

News(6)

  • Type 1 diabetes pipeline making ‘remarkable progress’ toward insulin independence
    After the trailblazing approval of Sanofi’s Tzield for stage 3 type 1 diabetes, several companies, including SAB Biotherapeutics and Eledon Pharmaceuticals, are vying for a spot in the landscape wi…
    biospace · 26d ago
  • FDA Approves New Indication for Tzield (teplizumab) for Certain Pediatric Patients with Recently Diagnosed Stage 3 Type 1 Diabetes
    On June 12, 2026, the U.S. Food and Drug Administration granted accelerated approval to Tzield (teplizumab) for a new indication, to delay the decline of insulin production in pediatric patients ag…
    fda_press · 2mo ago
  • STAT+: Lilly’s Ajax acquisition may have been worth it
    A syphilis drug shortage, Sanofi's diabetes drug approval, and more biotech news from The Readout
    stat · 2mo ago
  • STAT+: FDA approves Sanofi diabetes drug for children with stage 3 diabetes
    The FDA has approved a drug that was previously caught in a dispute between career staff and the political appointee head of the CDER.
    stat · 2mo ago
  • STAT+: Pharmalittle: We’re reading about Sanofi and an FDA voucher, FDA rethinking a rejection, and more
    Sanofi asked the FDA to pull teplizumab out of a speedy review voucher program after a political appointee disagreed with staff over its approval
    stat · 3mo ago
  • STAT+: Sanofi asks to pull diabetes drug out of FDA voucher program after political appointee interfered with review
    Sanofi has asked the FDA to pull its type 1 diabetes drug out of Commissioner Marty Makary’s new speedy drug review program.
    stat · 3mo ago
brand
Tzield
trade names
Tzield
generic
teplizumab-mzwv
MOA
T-cell surface glycoprotein CD3 epsilon chain other
indication
Type 1 Diabetes (Juvenile Diabetes)
phase
pre_registration
Data sources
ClinicalTrials.gov · OpenTargets
last refreshed 1m ago
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