Drugs / Teplizumab
Teplizumab
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed type 1 diabetes mellitus 2 milestones | |||||
| Filed | US (FDA) | Tzield | type 1 diabetes mellitus | 2026-01-05 | “The US Food and Drug Administration (FDA) has accepted for priority review the supplemental biologic license application (sBLA)” sanofi.com ↗ |
| Filed | US (FDA) | — | type 1 diabetes mellitus | 2022-02-22 | “On February 22, 2022 , Provention announced that it had resubmitted the Biologics License Application (BLA) for teplizumab” macrogenics.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Teizeild | — | 2026-01-08 | europa.eu ↗ |
Trials 16
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT07610213 | Jan 2027 → Dec 2029 expected | type 1 diabetes mellitus | Abdullah Kars | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT01189422 | Aug 2010 → Feb 2011 | type 1 diabetes mellitus | MacroGenics | Terminated | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT03751007 | Oct 2018 → Oct 2021 | type 1 diabetes mellitus | Precigen Actobio T1D, LLC | Completed | No outcome recorded |
| Phase 1/2 | NCT00954915 | Dec 2009 → Jul 2010 | psoriasis | MacroGenics | Terminated | No outcome recorded |
| Phase 1/2 | NCT00008801 | — | type 1 diabetes mellitus | National Center for Research Resources (NCRR) | Unknown | No outcome recorded |
| Phase 26 trials · 1 met primary | ||||||
| Phase 2 | NCT06791291 | Jul 2025 → Mar 2028 expected | type 1 diabetes mellitus | Sanofi | Recruiting | No outcome recorded |
| Phase 2 | NCT04270942 | Feb 2020 → Jan 2024 | type 1 diabetes mellitus | Provention Bio, a Sanofi Company | Completed | No outcome recorded |
| Phase 2 | NCT00378508 | Sep 2006 → Aug 2011 | type 1 diabetes mellitus | Yale University | Completed | No outcome recorded |
| Phase 2 | NCT00239720 | Mar → Dec 2006 | psoriatic arthritis | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded |
| Phase 2 | NCT00129259 | Sep 2005 → Mar 2011 | type 1 diabetes mellitus | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Met primary |
| Phase 2 | NCT00806572 | May 2002 → Jul 2004 | type 1 diabetes mellitus | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded |
| Phase 2/31 trial · 1 missed | ||||||
| Phase 2/3 | NCT00385697 | Oct 2006 → Jun 2010 | type 1 diabetes mellitus | MacroGenics | Completed | Missed primary |
| Phase 33 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT07088068 | Aug 2025 → Jun 2028 expected | type 1 diabetes mellitus | Sanofi | Recruiting | No outcome recorded |
| Phase 3 | NCT03875729 | Apr 2019 → May 2023 | type 1 diabetes mellitus | Provention Bio, Inc. | Completed | Met primary |
| Phase 3 | NCT00920582 | Sep 2009 → Apr 2012 | type 1 diabetes mellitus | MacroGenics | Terminated | Missed primary Stop: Business |
| Phase 41 trial | ||||||
| Phase 4 | NCT05757713 | Jul 2023 → Aug 2026 | type 1 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT07216391 Comparator | Jul 2026 → Nov 2029 expected | type 1 diabetes mellitus | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Recruiting | No outcome recorded |
| Phase 2 | NCT01030861 Comparator | Aug 2010 → Nov 2018 | autoimmune disease, glucose intolerance | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2026-06-12 | Sanofi | Regulatory Press Release: Sanofi’s Tzield approved in the US as the first disease-modifying therapy for patients recently diagnosed with stage 3 type 1 diabetes sanofi.com ↗
The US Food and Drug Administration (FDA) has granted accelerated approval to Tzield (teplizumab-mzwv) to delay the decline in endogenous (own) insulin production in children aged eight to 17 years recently diagnosed with stage 3 T1D. |
| 2026-04-22 | Sanofi | Regulatory Press Release: Sanofi's Tzield approved in the US to delay the onset of stage 3 type 1 diabetes in young children sanofi.com ↗
The US Food and Drug Administration (FDA) has approved the supplemental biologic license application for Tzield (teplizumab-mzwv), expanding the indication from eight years and older to as young as one year of age to delay the onset of stage 3 type 1 diabetes (T1D) in patients diagnosed with stage 2 T1D. |
| 2026-01-12 | Sanofi | Regulatory Press Release: Sanofi’s Teizeild approved in the EU for patients with stage 2 type 1 diabetes sanofi.com ↗
The European Commission has approved Teizeild (teplizumab) to delay the onset of stage 3 type 1 diabetes (T1D) in adult and pediatric patients eight years of age and older with stage 2 T1D. |
| 2026-01-05 | Sanofi | Regulatory Press Release: Sanofi’s Tzield accepted for priority review in the US for young children with stage 2 type 1 diabetes sanofi.com ↗
The US Food and Drug Administration (FDA) has accepted for priority review the supplemental biologic license application (sBLA) for Tzield (teplizumab-mzwv) to expand the current age indication from eight years and above, to as young as one year old and above to delay the onset of stage 3 type 1 diabetes (T1D) in patients diagnosed with stage 2 T1D. |
| 2025-11-14 | Sanofi | Regulatory Press Release: Sanofi’s Teizeild recommended for EU approval by the CHMP for patients with stage 2 type 1 diabetes sanofi.com ↗
Sanofi’s Teizeild recommended for EU approval by the CHMP for patients with stage 2 type 1 diabetes |
| 2025-10-20 | Sanofi | Regulatory Press Release: Sanofi’s Tzield accepted for expedited review in the US for stage 3 type 1 diabetes through FDA Commissioner's National Priority Voucher pilot program sanofi.com ↗
We welcome that Tzield has been accepted for expedited review by the FDA under the Commissioner’s National Priority Voucher pilot program, potentially enabling us to go further and faster for patients and lead the way with breakthrough science, |
| 2025-09-10 | Sanofi | Regulatory Press Release: Tzield approved in China as first disease-modifying therapy for adult and pediatric patients with stage 2 type 1 diabetes sanofi.com ↗
Today, it is also approved in China, the UK, Canada, Israel, the Kingdom of Saudi Arabia, the United Arab Emirates, and Kuwait for the same indication. |
| 2023-10-18 | Sanofi | Results Press Release: TZIELD® Phase 3 data presented at ISPAD shows potential to slow the progression of Stage 3 type 1 diabetes in newly diagnosed children and adolescents; full data simultaneously published in The New England Journal of Medicine sanofi.com ↗
TZIELD met the study’s primary endpoint, demonstrating superior beta cell preservation assessed by significantly slowing the decrease in mean C-peptide levels (area under the curve [AUC] after a 4-hour mixed meal tolerance test) at trial completion, compared to placebo. |
| 2022-11-17 | MacroGenics | Regulatory MacroGenics Earns $60 Million Milestone with U.S. FDA Approval of Teplizumab macrogenics.com ↗
MacroGenics Earns $60 Million Milestone with U.S. FDA Approval of Teplizumab |
| 2010-10-21 | Eli Lilly and Company | Results Lilly Reports Third-Quarter 2010 Results lilly.com ↗
The DMC concluded that the primary efficacy endpoint of the study, a composite of a patient's total daily insulin usage and HbA1c level at 12 months, was not met. |
| 2010-10-20 | MacroGenics | Results MacroGenics and Lilly Announce Pivotal Clinical Trial of Teplizumab Did Not Meet Primary Efficacy Endpoint macrogenics.com ↗
MacroGenics and Lilly Announce Pivotal Clinical Trial of Teplizumab Did Not Meet Primary Efficacy Endpoint |
| 2010-10-20 | Eli Lilly and Company | Results MacroGenics and Lilly Announce Pivotal Clinical Trial of Teplizumab Did Not Meet Primary Efficacy Endpoint lilly.com ↗
The DMC concluded that the primary efficacy endpoint of the study, a composite of a patient's total daily insulin usage and HbA1c level at 12 months, was not met. |
All press releases naming this drug 18 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 20 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Teplizumab | “Our aim was to determine whether two courses of teplizumab, an Fc receptor-nonbinding anti-CD3 monoclonal antibody, reduces the decline in C-peptide levels in patients with T1D...” PMID 23835333 ↗ Jul 2013 |
| Known as | hOKT3gamma1 (Ala-Ala) | “hOKT3gamma1 (Ala-Ala) is a man-made antibody that is commonly used to prevent organ rejection.” NCT00239720 ↗ |
| Known as | mAb hOKT3gamma1(Ala-Ala) | “mAb hOKT3gamma1(Ala-Ala), MGA031, Teplizumab” NCT00378508 ↗ |
| Known as | MGA031 | “Subcutaneously Administered Teplizumab (MGA031) in Adults With Type 1 Diabetes Mellitus” NCT01189422 ↗1“mAb hOKT3gamma1(Ala-Ala), MGA031, Teplizumab” NCT00378508 ↗ |
| Known as | Tzield | “Teplizumab, a monoclonal antibody (manufactured by Provention Bio and marketed as Tzield), was recently approved by the Food and Drug Administration as the first preventative...” PMID 37158990 ↗ May 2023 |
| Action | Deplete | “this antibody selectively attacks the immune cells responsible for beta cell destruction” NCT00129259 ↗ |
| Modality | Monoclonal antibody | “anti-CD3 monoclonal antibody hOKT3gamma1 (Ala-ala)” NCT00008801 ↗ |
| Route | Intravenous | “anti-CD3 monoclonal antibody (mAb) intravenously (IV)” NCT00129259 ↗ |