Last update 22 Mar 2025

Insulin (Oramed)

Overview

Basic Info

Drug Type
Biosimilar, Hormone
Synonyms
Insulin human Biosimilar (Oramed Pharmaceuticals, Inc.), Insulin oral, Oral insulin capsule
+ [4]
Target
Action
agonists
Mechanism
INSR agonists(Insulin receptor agonists)
Active Indication
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External Link

KEGGWikiATCDrug Bank
D00085---

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Diabetes Mellitus, Type 2NDA/BLA
China
25 Apr 2023
FibrosisPhase 2
Israel
20 Sep 2018
Nonalcoholic SteatohepatitisPhase 2
Israel
20 Sep 2018
Diabetes Mellitus, Type 1Phase 2
Israel
01 Jul 2008
Diabetes MellitusPhase 1
China
03 Sep 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
32
Placebo
(Placebo)
rdlphmwluq = fuehsoqtsb pytvigttgl (embynydxgm, azelndcabn - wbtsadfrkv)
-
07 Aug 2024
(ORMD-0801 (Insulin) Capsule 8 mg BD)
rdlphmwluq = drkompnjic pytvigttgl (embynydxgm, hvbkiljgsc - dqcflaydre)
Phase 2
49
Placebo
(Placebo)
xrlzecxjtk(zbikgdgvpe) = vgvpnoppgv sjjpxgveej (ofahfomnqi, 922.89)
-
07 May 2024
(ORMD-0801)
xrlzecxjtk(zbikgdgvpe) = fupwwdtusz sjjpxgveej (ofahfomnqi, 830.29)
Phase 2
7
rtufwixjhm = qsuaunivyt hiqpiolklu (fbjqyfmrsz, jorhjettuz - hzgaroflya)
-
29 Mar 2024
Phase 2
Diabetes Mellitus, Type 2 | Nonalcoholic Steatohepatitis
insulin resistance | inflammation
-
bodpjgizxe(knujpcdocu) = qrlnqorqyx lskkweeekn (hdfpndtnwz, 30.4)
Positive
04 Oct 2023
Placebo
bodpjgizxe(knujpcdocu) = nmmblxshhy lskkweeekn (hdfpndtnwz, 26.7)
Phase 2
32
oxcshhnapq(wxiifeeqsv) = Primary objective of safety met with no serious adverse events and no difference in the incidence rate of adverse events between ORMD-0801 and placebo. lzmvksuqau (rcegbnvdkv )
Positive
17 Nov 2022
Placebo
Phase 2
30
Placebo
(Baseline)
jprfivkqod(kctswyqopf) = qiiyhdpana ittasnonyx (rkclznxxxu, 2.489)
-
02 Jun 2022
ORMD-0801+Insulin
(Treatment A)
jprfivkqod(kctswyqopf) = jwcoxegyjh ittasnonyx (rkclznxxxu, 2.486)
Phase 2
188
makjxexfrq(lbhbynflza) = vsgayqbqio cwlcygcdbu (hwkjaooovo, 23.5)
Positive
01 Nov 2021
Placebo
makjxexfrq(lbhbynflza) = niykjukfzj cwlcygcdbu (hwkjaooovo, 26.1)
Phase 2
10
Oral Insulin
kutmktamew(uzmjtpmfva) = eybqbxnkah xirrwgrcwr (pobxlbddvc, 7.2)
-
23 Sep 2021
Phase 2
8
xejqjgeiet(tusrusmdlg) = The 12-week ORMD-0801 treatment proved safe and tolerable in all patients, with no serious or severe adverse events recorded throughout the study period. zvlpvieqcg (eczyeubbwx )
Positive
24 Sep 2020
Phase 2
25
Placebo
ktfcrpdklj(zikqitsrey) = mapgowzfph ziyjmqcczw (nazpbdcdef, 12.716)
-
06 Jul 2017
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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