Drugs / Teplizumab
Teplizumab
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Teizeild | — | 2026-01-08 | europa.eu ↗ |
Trials 16 · a red edge is where a trial was stopped
| 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 | ||||||
| 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 | No outcome recorded |
| 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 | ||||||
| Phase 2/3 | NCT00385697 | Oct 2006 → Jun 2010 | type 1 diabetes mellitus | MacroGenics | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| 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 | No outcome recorded |
| Phase 3 | NCT00920582 | Sep 2009 → Apr 2012 | type 1 diabetes mellitus | MacroGenics | Terminated | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT05757713 | Jul 2023 → Aug 2026 overdue | type 1 diabetes mellitus | Sanofi | Active not recruiting | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT07216391 Comparator | Jul 2026 → Nov 2029 expected | type 1 diabetes mellitus | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Not yet 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 |
Press releases naming this drug 7 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-06-12 | Sanofi | 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 ↗ |
| 2026-04-22 | Sanofi | Press Release: Sanofi's Tzield approved in the US to delay the onset of stage 3 type 1 diabetes in young children sanofi.com ↗ |
| 2026-01-05 | Sanofi | Press Release: Sanofi’s Tzield accepted for priority review in the US for young children with stage 2 type 1 diabetes sanofi.com ↗ |
| 2025-10-20 | Sanofi | 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 ↗ |
| 2025-09-10 | Sanofi | Press Release: Tzield approved in China as first disease-modifying therapy for adult and pediatric patients with stage 2 type 1 diabetes sanofi.com ↗ |
| 2023-10-18 | Sanofi | 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 ↗ |
| 2023-03-13 | Sanofi | Press Release: Sanofi to acquire Provention Bio, adding to portfolio TZIELD, the first disease-modifying treatment for the delay of Stage 3 type 1 diabetes (T1D) sanofi.com ↗ |
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 ↗ |