Teplizumab clinical trials
Teplizumab is named as an intervention in 7 current clinical trials in our Germany, USA, UK, France, Belgium, Spain, Italy, Poland, Czechia, Canada, Japan, Israel, China, Netherlands, Switzerland, Brazil, Australia and Turkey registers. 5 are recruiting patients now. The most common phase is Observational. The sponsor with the most trials is Sanofi (5). The most-studied condition is Type 1 Diabetes.
Where Teplizumab is approved
All regulators →Of the three regulators tracked here, the first to approve Teplizumab was the US, on 17 Nov 2022. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Teplizumab
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Teplizumab works
All drug targets →- T-cell surface glycoprotein CD3 epsilon chain other OtherTarget: CD3E CD3 epsilon subunit of T-cell receptor complex✓ In ChEMBL and the Guide to Pharmacology
- MelanomaPhase 3
- Psoriatic arthritisPhase 2
- HypoglycemiaPhase 1/2
- PsoriasisPhase 1/2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1743078, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 12252, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Teplizumab
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Teplizumab. 1 is current, and 1 of it recommends it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Teplizumab for delaying the onset of stage 3 type 1 diabetes in people 8 years and over with stage 2 type 1 diabetes NICE TA1176 | Recommended | 9 Jul 2026 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Teplizumab
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 1 product on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: TeizeildEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Trials by status
Trials by phase
Clinical trials of Teplizumab
7 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Teplizumab across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
1 single-substance product containing Teplizumab on the HPRA medicines list.
- Teizeild 1 mg/mL concentrate for solution for infusionSanofi Winthrop Industrie · EU/1/25/1998/001-003
Supply shortages
No entry for Teplizumab in the EMA, FDA or German BfArM shortage lists we track.
Recent approvals
- TeizeildEMA · 8 Jan 2026 · Sanofi Winthrop Industrie
Conditions studied with Teplizumab
5 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Sanofi | 5 |
| Provention Bio, a Sanofi Company | 1 |
| Abdullah Kars | 1 |
By country register
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Teplizumab trials
How many clinical trials are testing Teplizumab?
7 current trials in our Germany, USA, UK, France, Belgium, Spain, Italy, Poland, Czechia, Canada, Japan, Israel, China, Netherlands, Switzerland, Brazil, Australia and Turkey registers name Teplizumab (also registered as SAR446681) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Teplizumab trials recruiting patients?
Yes. 5 of the 7 trials are recruiting: 3 with sites in Germany, 3 with sites in USA, 2 with sites in UK, 2 with sites in France, 2 with sites in Belgium, 2 with sites in Spain, 2 with sites in Italy, 1 with sites in Poland, 1 with sites in Czechia, 1 with sites in Canada, 2 with sites in Japan, 2 with sites in Israel, 1 with sites in China, 1 with sites in Netherlands, 1 with sites in Switzerland, 1 with sites in Brazil and 1 with sites in Australia. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Teplizumab clinical trials?
Sanofi (5), Provention Bio, a Sanofi Company (1) and Abdullah Kars (1). The number in brackets is how many trials each organisation leads.
Is Teplizumab licensed in Ireland?
Yes. The HPRA medicines list includes 1 single-substance product containing Teplizumab, for example Teizeild 1 mg/mL concentrate for solution for infusion (Sanofi Winthrop Industrie). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Teplizumab shortage?
Not in the lists we track: Teplizumab has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Teplizumab works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Teplizumab works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Teplizumab (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.