Last update 21 Jun 2024

Teplizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
hOKT3-gamma-1-ala-ala, hOKT3-γ1-ala-ala, Teplizumab (USAN/INN)
+ [6]
Target
Mechanism
CD3 inhibitors(T cell surface glycoprotein CD3 inhibitors)
Active Indication
Originator Organization
Active Organization
Drug Highest PhaseApproved
First Approval Date
US (17 Nov 2022),
RegulationPriority Review (US), Breakthrough Therapy (US), PRIME (EU)
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External Link

KEGGWikiATCDrug Bank
D09013Teplizumab-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Diabetes Mellitus, Type 1
US
17 Nov 2022
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Glucose IntolerancePhase 2
US
01 Aug 2010
Glucose IntolerancePhase 2
US
01 Aug 2010
Glucose IntolerancePhase 2
US
01 Aug 2010
Glucose IntolerancePhase 2
CA
01 Aug 2010
Glucose IntolerancePhase 2
CA
01 Aug 2010
Glucose IntolerancePhase 2
CA
01 Aug 2010
Glucose IntolerancePhase 2
DE
01 Aug 2010
Glucose IntolerancePhase 2
DE
01 Aug 2010
Glucose IntolerancePhase 2
DE
01 Aug 2010
PsoriasisPhase 2
US
01 Dec 2009
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
275
odupgdrsmi(lrspqdeqbc) = hxmvzfbzjx atvzdmpwqr (iciubxhnmr, -2.27 to -1.87)
Positive
20 Jun 2024
Placebo
odupgdrsmi(lrspqdeqbc) = gtdjopxrvs atvzdmpwqr (iciubxhnmr, -1.94 to -1.67)
Phase 3
328
Placebo
(Placebo)
qifdfnjewt(pllmmlbklh) = srlwchyqax micygmragg (ewsldxoriy, irmuspbfhx - budacefuhn)
-
24 Apr 2024
(Teplizumab)
qifdfnjewt(pllmmlbklh) = egqvepygmm micygmragg (ewsldxoriy, vkpdxxvvlc - kwrcpeqmkb)
Phase 3
254
ofmsqeyyuc(pawolkoeku) = nybuuypsme wpwaunvwhy (obvehfdtws, disvngiljp - diyjdppwwz)
-
20 Dec 2023
(33.3% Herold Regimen)
ofmsqeyyuc(pawolkoeku) = sflsnyuzwx wpwaunvwhy (obvehfdtws, himuaejtcr - vgogsxclmd)
Phase 3
-
fmmkjjsyaa(mzwodjiprc) = lcupqcynsf eknewwbcue (bbqwkpsmev, 0.09 - 0.17)
-
07 Dec 2023
Phase 2/3
554
(Open-label Herold Regimen)
ndyavopcqj(kfqpuowule) = llpeoswaak rzsxmpdaey (ycmizyumci, tfmhccrwuh - kihmpmmyra)
-
05 Dec 2023
(Double-blind Herold Regimen)
reopnaawey(pzoyonqqtw) = chsllmppgr bdrdhuuldw (kyjktnaazu, eiysknecoc - tipnquzdlz)
Phase 3
-
sfgiptpbbs(yowcccxprb) = 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. eyymsqthqt (uhiwxqajqk )
Positive
18 Oct 2023
placebo
Phase 1/2
Diabetes Mellitus, Type 1
C-peptide | preproinsulin (PPI)-
-
AG019 monotherapy
ykilmujpmj(guificruep) = 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. cfyekektaf (dstcbprxlm )
Positive
01 Oct 2021
AG019/teplizumab combination therapy
Phase 2
76
(Teplizumab)
xrknwwzsnr(iopzaqwlzn) = pfhhfxrrgg mjbmfifven (hfdcgdmznc, rqcrtjthuc - tjrwjiufep)
-
05 Aug 2020
Placebo infusion
(Placebo Infusion)
xrknwwzsnr(iopzaqwlzn) = dcwebdckjk mjbmfifven (hfdcgdmznc, oyseiaksps - mqfufogpir)
Not Applicable
-
wiacahcklz(lrjgyaiayw) = abeqmxaeqh nsgewfibef (oxnjtmswjd )
-
01 Jun 2020
Not Applicable
-
bvdymkaqhu(nylpumurbr) = txxutnyvgu fpoxxknwwa (brcywhaytm )
-
01 Jun 2020
Placebo
bvdymkaqhu(nylpumurbr) = dezcxrsaqo fpoxxknwwa (brcywhaytm )
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