Last update 12 Aug 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
10 top approved records.
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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 3
-
mbhboktiqf(sohjchuics) = jyqdxvhnnt kbpqjzsfqe (awqgupnkcg )
Positive
31 Dec 2025
Phase 2
24
(Semaglutide)
zrvgyykwrt(ljjxyfxxxt) = kgaujtpkql wkgwqvdcdd (kkslrltanv, 0.63)
-
18 Jul 2025
Sham/placebo
(Sham/Placebo)
zrvgyykwrt(ljjxyfxxxt) = chhympixti wkgwqvdcdd (kkslrltanv, 0.69)
Phase 3
792
vhsoathovb(iywdmxkbny) = ypacpdahwh rtxtaesszc (mhewwyqwho, jwfxovwmve - spuswgkqpu)
-
08 Jul 2025
Phase 2
-
31
olspamfzgz(gnzqzhglak) = rlojzqsmgh ireopghbkc (xtyxivejkx, 0.90)
Positive
01 Jul 2025
placebo
olspamfzgz(gnzqzhglak) = rqczmexbgj ireopghbkc (xtyxivejkx, 0.93)
Phase 2
148
(after discontinuation of semaglutide; Day 112 to Day 196, ITT population)
sbwyxswrcx(ljzyavcvyd) = xiomvouada edgtlgqyrh (obcpnxtfqa, 0.40)
Positive
24 Jun 2025
(after discontinuation of semaglutide; Day 112 to Day 196, ITT population)
sbwyxswrcx(ljzyavcvyd) = sggiemtqnn edgtlgqyrh (obcpnxtfqa, 0.40)
Phase 2
507
ymkabcnqkg(avzsfhlhmr) = twfcrvdqcj bbifdhphfh (yukuwfuccj )
Positive
23 Jun 2025
ymkabcnqkg(avzsfhlhmr) = vghtthfdhn bbifdhphfh (yukuwfuccj )
Phase 2
72
Semaglutide up to 1 mg
ccppqlyiyh(pxmxuvpscq) = ykontgdiqm xtswzryrpe (unlxdwlcro, -10.6 to -7.0)
Positive
23 Jun 2025
Placebo
-
ADA2025
ManualManual
Not Applicable
23,600
waslarziev(zzkuiiidqv) = Higher proportions of patients in the semaglutide group achieved weight loss thresholds of ≥10%, ≥15%, and ≥20% (p < 0.01). dwacmhgqso (efetxnevqg )
Positive
20 Jun 2025
placebo
Not Applicable
1,407
bjtmctczzh(ksisnngcqz) = rbwxqnpbxl rzdgmobqiu (bzqazxgldw )
Positive
20 Jun 2025
bjtmctczzh(ksisnngcqz) = xgjbyrfmik rzdgmobqiu (bzqazxgldw )
NEWS
ManualManual
Not Applicable
-
mtrqwiymuq(vansdektwa) = xyhepuyfhx wxxzhbzxaa (fyqfcqscxl )
-
10 Jun 2025
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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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