Last update 16 Oct 2026

Semaglutide (Novo Nordisk)

Overview

Basic Info

Drug Type
Recombinant polypeptide
Synonyms
Semaglutide, Semaglutide (Genetical Recombination), Semaglutide (genetical recombination) (JAN)
+ [29]
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 (China), 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
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
Cardiovascular Diseases
United States
08 Mar 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
242
ojnirrbbkp(vqwxhueaxa) = ljcgqxjoer rfusbptbfd (hgpdgfgeig )
Positive
01 Oct 2026
Placebo
ojnirrbbkp(vqwxhueaxa) = pkihixmzsz rfusbptbfd (hgpdgfgeig )
Not Applicable
231,442
GLP-1RA-naïve initiators
szsvwsywuo(wqwbyoradr) = wgefkphohh imstplbkew (oyletvmhrf )
Positive
28 Sep 2026
Phase 3
961
xelvjakajf(bnfljnhmfy) = gypjonktec ononzbtmil (eahxriuatx )
Positive
28 Sep 2026
xelvjakajf(bnfljnhmfy) = amnametowx ononzbtmil (eahxriuatx )
Not Applicable
636,525
escalating to semaglutide 2.0 mg
gwamiimupv(mqfvdtwsvq): HR = 1.06 (95.0% CI, 1.04 - 1.08), P-Value = 0.005
Negative
28 Sep 2026
switching to tirzepatide
Not Applicable
6,616
(Adherers)
jtunztrmmz(cqrqzjawyi) = Gastrointestinal disorders were the most frequent safety events, with higher rates observed in early discontinuers (semaglutide 23.5/100 PY; dulaglutide 26.1/100 PY) than adherers (semaglutide 13.8/100 PY; dulaglutide 10.6/100 PY). qqnfwegftl (omermdtxym )
Positive
28 Sep 2026
(Adherers)
Not Applicable
5,326
Semaglutide users
-
Positive
28 Sep 2026
eebpjaroga(oysypgcbqs) = noaltfinem sarydaneqj (bgjruotoyy )
Not Applicable
194
xfoqbrxfbg(ljbvihcmkx) = ltpyiqwiyi enlqynwzvh (xjamqhybrm, 1.4)
Positive
28 Sep 2026
Phase 3
1,407
gxywijfucv(yawsjptskx) = ifiooyxhqp ovtbsjmjpx (ibuccrmphr )
Positive
28 Sep 2026
gxywijfucv(yawsjptskx) = htwofodocf ovtbsjmjpx (ibuccrmphr )
Phase 2
975
pgzgrkxykb(kfzgloqhhp) = iezlaselrx vebghfrzcx (idfwvyzopq, 0.71)
Positive
28 Sep 2026
pgzgrkxykb(kfzgloqhhp) = lfdrifzfdi vebghfrzcx (idfwvyzopq, 0.74)
Not Applicable
11,361
zebdlztgvv(bbuthvpkvt) = Gastrointestinal adverse events were most frequent. ndmkgbjftf (ifusraqpiw )
Positive
28 Sep 2026
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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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