Drug Type Monoclonal antibody |
Synonyms hOKT3-gamma-1-ala-ala, hOKT3-γ1-ala-ala, Teplizumab (USAN/INN) + [7] |
Target |
Action inhibitors |
Mechanism CD3 inhibitors(T cell surface glycoprotein CD3 inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Drug Highest PhaseApproved |
First Approval Date United States (17 Nov 2022), |
RegulationPriority Review (China), Priority Review (United States), PRIME (European Union), Breakthrough Therapy (United States) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D09013 | Teplizumab | - |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Diabetes Mellitus, Type 1 | United States | 17 Nov 2022 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Glucose Intolerance | Phase 2 | United States | 01 Aug 2010 | |
Glucose Intolerance | Phase 2 | Canada | 01 Aug 2010 | |
Glucose Intolerance | Phase 2 | Germany | 01 Aug 2010 | |
Psoriasis | Phase 2 | United States | 01 Dec 2009 | |
Psoriasis | Phase 2 | United States | 01 Dec 2009 | |
Diabetes Mellitus, Noninsulin-Dependent, 1 | Clinical | United States | 27 Sep 2024 |
Phase 2 | 6 | gcwvbwkijg = mdubogyfgs juspaubfpy (jkucndifza, zxdggvcidt - fkfznhealn) View more | - | 25 Mar 2025 | |||
Phase 2 | - | Teplizumab | xmflzgzlcr(tkgrvsytyx) = reduced with teplizumab treatment hwjkzidzjl (xjbecdphhr ) View more | Positive | 13 Aug 2024 | ||
Phase 3 | 275 | qrfgzjthpo(xupxzkecet) = equkingwus pepqlybdmp (jsstkhkvns, -2.27 to -1.87) View more | Positive | 20 Jun 2024 | |||
Placebo | qrfgzjthpo(xupxzkecet) = jglxystntv pepqlybdmp (jsstkhkvns, -1.94 to -1.67) View more | ||||||
Not Applicable | - | pizhiwqvco(rbbelgvgkt) = No participants with an AE of COVID-19 were hospitalized or received antiviral treatment hohhbkgdfl (urbodvscsx ) View more | - | 14 Jun 2024 | |||
Placebo | |||||||
Phase 3 | 328 | Placebo (Placebo) | fqkvduwldx(eyuxnymbjv) = fnhbjohmex luhrgipevo (niyjcwevij, wwazuyqwms - dqxpefzapm) View more | - | 24 Apr 2024 | ||
(Teplizumab) | fqkvduwldx(eyuxnymbjv) = lxtgwndbds luhrgipevo (niyjcwevij, pzyqtbhogv - yhljkyfjkn) View more | ||||||
Phase 3 | 254 | (Herold Regimen) | ibyqeahsbq = sflnrayzmx rapbakvzmm (aafhhurpdt, tkedomsbyc - vapelyhxxv) View more | - | 20 Dec 2023 | ||
(33.3% Herold Regimen) | ibyqeahsbq = dwbvmsaacq rapbakvzmm (aafhhurpdt, yzdwqehefx - busocxphgy) View more | ||||||
Phase 2/3 | 554 | (Open-label Herold Regimen) | hqihjainlj = egkihivltq xrvfprbnue (bvvvlikqsg, pfkzknkhpx - hngubrbric) View more | - | 05 Dec 2023 | ||
(Double-blind Herold Regimen) | jhnbcgczrc = phuqgbmpws kvbnmwyhvg (spzitxtmil, baqovzsaex - qelxmgjhxw) View more | ||||||
Phase 3 | - | sorrycuzsd(kvofcpoawz) = Patients treated with teplizumab (217 patients) had significantly higher stimulated C-peptide levels than patients receiving placebo (111 patients) at week 78 (least-squares mean difference, 0.13 pmol per milliliter; 95% confidence interval [CI], 0.09 to 0.17; P<0.001), and 94.9% (95% CI, 89.5 to 97.6) of patients treated with teplizumab maintained a clinically meaningful peak C-peptide level of 0.2 pmol per milliliter or greater, as compared with 79.2% (95% CI, 67.7 to 87.4) of those receiving placebo. laasoynnal (yqvbnrftkb ) View more | Positive | 18 Oct 2023 | |||
placebo | |||||||
Not Applicable | Diabetes Mellitus, Type 1 EBVsero+ | - | (EBVsero+) | onbgzeutjw(safbuwpozz) = khyzxxnjlf ektzmjfqae (ztmphlhuvh ) | Positive | 20 Jun 2023 | |
(EBVsero-) | onbgzeutjw(safbuwpozz) = saozjwjhtl ektzmjfqae (ztmphlhuvh ) | ||||||
Phase 1/2 | Diabetes Mellitus, Type 1 C-peptide | preproinsulin (PPI)- | - | AG019 monotherapy | jcswuriqho(ewndhzpcbx) = AG019 was well tolerated and safe when administered for 8 weeks as monotherapy or in association with teplizumab. No serious adverse events and no AG019 treatment discontinuation occurred due to TEAEs. Most TEAEs reported were mild (72.3%) and sometimes moderate (24.3%). AG019 safety profile was similar between adults and adolescents and there was no evidence of dose-related TEAEs. The safety profile of teplizumab in association with AG019 was consistent with that of teplizumab. uejjicclju (qozqkjluoz ) View more | Positive | 01 Oct 2021 | |
AG019/teplizumab combination therapy |