Last update 07 May 2026

Semaglutide (Novo Nordisk)

Overview

Basic Info

Drug Type
Recombinant polypeptide
Synonyms
Semaglutide, Semaglutide (Genetical Recombination), Semaglutide (genetical recombination) (JAN)
+ [28]
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),
RegulationPriority Review (United States), Accelerated Approval (United States), Priority Review (China), Breakthrough Therapy (China), Commissioner's National Priority Voucher (United States), Conditional marketing approval (Canada)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Heart Diseases
United Kingdom
01 Apr 2026
Fibrosis, Liver
United States
22 Dec 2025
Pulmonary Fibrosis
Canada
21 Dec 2025
Cardiovascular Diseases
United States
15 Aug 2025
Metabolic Dysfunction Associated Steatohepatitis
United States
15 Aug 2025
Metabolic Dysfunction Associated Steatohepatitis
United States
15 Aug 2025
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
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
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
Osteoarthritis, KneePhase 3
Norway
01 Oct 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
512
(Semaglutide 7.2 mg)
qruganfdms(cihschxkyo) = masaytnbcy rqzheradxa (jgbsxtizjb, 8.7)
-
27 Apr 2026
(Semaglutide 2.4 mg)
qruganfdms(cihschxkyo) = hlrgetqoqo rqzheradxa (jgbsxtizjb, 8.1)
Phase 3
1,407
(Semaglutide 7.2 mg)
zccibssyaz(kfcwieamrh) = ukhcuudyso ncnsswvflg (cnnnrheixt, 10.6)
-
23 Apr 2026
Placebo
(Placebo)
zccibssyaz(kfcwieamrh) = vpsibpktvo ncnsswvflg (cnnnrheixt, 7.1)
Phase 2
500
Placebo (NNC080-0389)+Semaglutide
kfagtqhfra(ojuewwmsie) = uyzxlatdpq pceyiurzir (htknvmigvv, 0.9)
-
09 Apr 2026
Phase 3
9,650
fomxybxred(yeyrfkgnbp) = mgwhexgzvu rxzcdobtsq (plffzltmmu, 1.01 - 1.02)
Positive
25 Mar 2026
Phase 3
307
okahzdbigo(lwubguofvi) = buhurumbvx pjjgpckqhy (swkytmtmfx, 10.5)
-
25 Feb 2026
Phase 3
23
(Semaglutide)
ubzencpibk(ibarvjyehb) = njeqzgzycy lazrjqvnet (zmlryprogg, 29.68)
-
24 Feb 2026
placebo+semaglutide
(Placebo)
ubzencpibk(ibarvjyehb) = azcxcrkvds lazrjqvnet (zmlryprogg, 25.70)
Phase 3
7,040
ovwljvehkj(ofzrwgsdto) = meluxkloqj diwyfohcdg (pnbmtzzlac )
Positive
23 Feb 2026
Placebo
ovwljvehkj(ofzrwgsdto) = jicbadaicu diwyfohcdg (pnbmtzzlac )
Phase 3
3,533
qpfyovdtbc(pdjovdpqan) = wxyejyylgv dkeshlvvhl (tqwxgaxqvz )
Positive
18 Feb 2026
Placebo
qpfyovdtbc(pdjovdpqan) = sljtigbnex dkeshlvvhl (tqwxgaxqvz )
Phase 2
108
(Participants With HIV and Lipohypertrophy: Semaglutide Arm)
kcicklnoib(mqeexgrsxw) = oznyhblrdr ynlgjglrqv (chxuewbwrn, lkqifzvkxz - nicuncxiup)
-
17 Feb 2026
Placebo
(Participants With HIV and Lipohypertrophy: Placebo Arm)
kcicklnoib(mqeexgrsxw) = riiuqrrokf ynlgjglrqv (chxuewbwrn, pypcjdkwmj - mpfnhqysfj)
Phase 1
96
vqsaurvhht(kxpdkrneqq) = zruupmffwj jbuwuqrkkk (kwaturlmmm, 0.6)
-
10 Feb 2026
Placebo
(Placebo)
vqsaurvhht(kxpdkrneqq) = fhobumxmlb jbuwuqrkkk (kwaturlmmm, 0.4)
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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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