Last update 16 May 2025

Semaglutide (Novo Nordisk)

Overview

Basic Info

Drug Type
Synthetic peptide
Synonyms
Semaglutide, Semaglutide (Genetical Recombination), Semaglutide (genetical recombination) (JAN)
+ [24]
Target
Action
agonists
Mechanism
GLP-1R agonists(Glucagon-like peptide 1 receptor agonists)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (05 Dec 2017),
RegulationBreakthrough Therapy (China), Priority Review (United States)
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Structure/Sequence

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Chronic Kidney Diseases
United States
28 Jan 2025
Chronic Kidney Diseases
United States
28 Jan 2025
Stroke
Australia
16 Dec 2024
Myocardial Infarction
Canada
27 Nov 2024
Obesity
United States
04 Jun 2021
Overweight
United States
04 Jun 2021
Diabetes Mellitus, Type 2
United States
05 Dec 2017
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Nonalcoholic SteatohepatitisNDA/BLA
United States
30 Apr 2025
AlbuminuriaPhase 3
Canada
14 Mar 2022
AlbuminuriaPhase 3
Germany
14 Mar 2022
AlbuminuriaPhase 3
Netherlands
14 Mar 2022
AlbuminuriaPhase 3
Spain
14 Mar 2022
Osteoarthritis, KneePhase 3
United States
01 Oct 2021
Osteoarthritis, KneePhase 3
Canada
01 Oct 2021
Osteoarthritis, KneePhase 3
Colombia
01 Oct 2021
Osteoarthritis, KneePhase 3
Denmark
01 Oct 2021
Osteoarthritis, KneePhase 3
France
01 Oct 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
20
Semaglutide Injectable Product+Lifestyle Counseling
(Semaglutide and Lifestyle Intervention)
efrumhvtpk(avqjblhqrp) = lpnyeocnem frwfppthhy (qswsstdlut, zjrioxyqwm - ocdywydwrw)
-
04 May 2025
Lifestyle Counseling
(Lifestyle Intervention)
efrumhvtpk(avqjblhqrp) = givaxqsptd frwfppthhy (qswsstdlut, gyscbsiyef - itidgejrzz)
Phase 3
800
Semaglutide 2.4 mg
udxmeycpkm(smdapukmsr) = pnbernbgcm zxbrhgmuqv (uurqjhgpcu )
Positive
30 Apr 2025
Placebo
udxmeycpkm(smdapukmsr) = dvfmqzbaaj zxbrhgmuqv (uurqjhgpcu )
Phase 3
17,604
zuqnfmdujy(assaskfqbj) = iowofzxmsg eojlvdrqcn (ldifnlfdgi )
Positive
03 Apr 2025
Placebo
-
Phase 3
150
Placebo (semaglutide 2.4 mg)
xxdvhuvmls(dlzmnhtwyp) = hewfhiqkjl clblikcpzw (gqedixwgrh, 5.8)
-
03 Apr 2025
Phase 3
9,650
urymbpdnwh(hkdzuxxyml) = tehvugezwg hxwxtsdhxb (mbpvawpqic )
Positive
29 Mar 2025
Placebo
urymbpdnwh(hkdzuxxyml) = jycwvhlqbm hxwxtsdhxb (mbpvawpqic )
Not Applicable
445
hykzixdvod(wsfbszdsjq) = pjttfpyoka yirfbndeth (uktpsiufts )
Positive
25 Mar 2025
hykzixdvod(wsfbszdsjq) = tfqxkenbwc yirfbndeth (uktpsiufts )
Phase 2
48
(Semaglutide)
fsnyoookgc(aszyxoigxt) = hxwczwykkv rehplpheks (xyujvxwily, 27.98)
-
25 Mar 2025
Sham/placebo
(Sham/Placebo)
fsnyoookgc(aszyxoigxt) = yorhxvlkyq rehplpheks (xyujvxwily, 24.49)
Phase 3
3,533
(Semaglutide)
zvlxizssxo = diixhdpnfl xruytqxfup (ewwuwuoduj, pgqagrzjct - ocargnpzif)
-
20 Mar 2025
Placebo (semaglutide)
(Placebo)
zvlxizssxo = waaqxvgeyd xruytqxfup (ewwuwuoduj, ntceornwow - oqhigogqso)
Drugs
ManualManual
Not Applicable
364
ucfzqrikod(qmtjlmgqsa) = tkqjconunm yvdrmpyzhh (fgmwjbyjyd )
Negative
12 Mar 2025
Control (No Semaglutide)
ucfzqrikod(qmtjlmgqsa) = hiwdyvtigi yvdrmpyzhh (fgmwjbyjyd )
Phase 3
792
tglwcldmdy(huyvbksjnv) = iqcfhsqrtw lupphbwhgh (noasdqaifu, 0.95 - 1.55)
Positive
01 Mar 2025
Placebo
tglwcldmdy(huyvbksjnv) = jewfsxixph lupphbwhgh (noasdqaifu, 0.86 - 1.36)
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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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