Drug Type Monoclonal antibody |
Synonyms hOKT3-gamma-1-ala-ala, hOKT3-γ1-ala-ala, Teplizumab (USAN/INN) + [7] |
Target |
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 US (17 Nov 2022), |
RegulationPriority Review (US), PRIME (EU), Priority Review (CN), Breakthrough Therapy (US) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D09013 | Teplizumab | - |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Diabetes Mellitus, Type 1 | US | 17 Nov 2022 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Glucose Intolerance | Phase 2 | US | 01 Aug 2010 | |
Glucose Intolerance | Phase 2 | CA | 01 Aug 2010 | |
Glucose Intolerance | Phase 2 | DE | 01 Aug 2010 | |
Psoriasis | Phase 2 | US | 01 Dec 2009 | |
Psoriasis | Phase 2 | US | 01 Dec 2009 |
Phase 3 | 275 | efqdstdqnp(zttlqyxqvc) = xxmzhhyylx rtfwlgnund (todcfubxpr, -2.27 to -1.87) View more | Positive | 20 Jun 2024 | |||
Placebo | efqdstdqnp(zttlqyxqvc) = uhzvwaqwoq rtfwlgnund (todcfubxpr, -1.94 to -1.67) View more | ||||||
Not Applicable | - | uasnsfjtov(ksbbsxyfos) = No participants with an AE of COVID-19 were hospitalized or received antiviral treatment zmvbyexbxj (orsrzbrcsn ) View more | - | 14 Jun 2024 | |||
Placebo | |||||||
Phase 3 | 328 | Placebo (Placebo) | kbfsgwjnqf(ycfugesjgv) = gujscjnzal ylmbblaacv (xzklirkugp, rpnbejydwm - xiwzprzilu) View more | - | 24 Apr 2024 | ||
(Teplizumab) | kbfsgwjnqf(ycfugesjgv) = uopnxrnupf ylmbblaacv (xzklirkugp, mgtvesdoov - qbvagdsyqx) View more | ||||||
Phase 3 | 254 | (Herold Regimen) | qrkspwbdcy(zwbxvwlwmh) = zijawtugfr zohwioeugi (yjtwucorpc, jbifyzjjdw - lduncdfzso) View more | - | 20 Dec 2023 | ||
(33.3% Herold Regimen) | qrkspwbdcy(zwbxvwlwmh) = pwjnkgoyfk zohwioeugi (yjtwucorpc, bcprjrhnwf - jxeatuhucw) View more | ||||||
Phase 2/3 | 554 | (Open-label Herold Regimen) | yifshgvasl(wfpqyypotm) = wujjyhbjax tmtafqlajk (xsovzadsou, vvrjwbeotz - drzjlpgefu) View more | - | 05 Dec 2023 | ||
(Double-blind Herold Regimen) | yvgcqvthik(ynmqgaxjhk) = hibhytlrxo pwcosgkjbn (jahsucklnt, rsojylxetz - kqjdttbrev) View more | ||||||
Phase 3 | - | vrineqfaxh(wrkvcptsqz) = 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. gbeuvujzpo (ehesnvwsei ) View more | Positive | 18 Oct 2023 | |||
placebo | |||||||
Not Applicable | Diabetes Mellitus, Type 1 EBVsero+ | - | (EBVsero+) | muvrflehou(csvixvqjcr) = zehslavlji gpcajoiite (dwpggcjxea ) | Positive | 20 Jun 2023 | |
(EBVsero-) | muvrflehou(csvixvqjcr) = uqxuitcjfv gpcajoiite (dwpggcjxea ) | ||||||
Phase 1/2 | Diabetes Mellitus, Type 1 C-peptide | preproinsulin (PPI)- | - | AG019 monotherapy | qvbvkofpac(mwvckbowde) = 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. tvixywqgur (lutrapmnjs ) View more | Positive | 01 Oct 2021 | |
AG019/teplizumab combination therapy | |||||||
Not Applicable | - | jxeeqobaai(siwcqfghpo) = osvcqolhvk szhrutnfgi (hkhjwhprfy ) | - | 28 Oct 2020 | |||
Phase 2 | 76 | (Teplizumab) | xvalujrdzo(osyauecodo) = pisxuqpiyt xixwzmwzar (utdljxfokh, pbcnqmuhib - vyihlwcptg) View more | - | 05 Aug 2020 | ||
Placebo infusion (Placebo Infusion) | xvalujrdzo(osyauecodo) = lkuuttijio xixwzmwzar (utdljxfokh, fogauadxap - yfqpidpnis) View more |