semaglutide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
Glucagon-like Peptide (GLP) analogues 5267 910463-68-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • rybelsus
  • semaglutide
  • NNC 0113-0217
  • ozempic
Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1. GLP-1 is a physiological hormone that has multiple actions on glucose, mediated by the GLP-1 receptors. The principal mechanism of protraction resulting in the long half-life of semaglutide is albumin binding, which results in decreased renal clearance and protection from metabolic degradation. Furthermore, semaglutide is stabilized against degradation by the DPP-4 enzyme. Semaglutide reduces blood glucose through a mechanism where it stimulates insulin secretion and lowers glucagon secretion, both in a glucose-dependent manner. Thus, when blood glucose is high, insulin secretion is stimulated and glucagon secretion is inhibited. The mechanism of blood glucose lowering also involves a minor delay in gastric emptying in the early postprandial phase.
  • Molecular weight: 4113.64
  • Formula: C187H291N45O59
  • CLOGP:
  • LIPINSKI: None
  • HAC: 104
  • HDO: 57
  • TPSA: 1646.18
  • ALOGS:
  • ROTB: 149

Drug dosage:

DoseUnitRoute
10.50 mg O
0.11 mg P

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Feb. 8, 2018 EMA Novo Nordisk A/S
Dec. 5, 2017 FDA NOVO NORDISK INC
March 23, 2018 PMDA Novo Nordisk Pharma Ltd

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Pancreatitis 355.87 22.38 159 7635 42455 50554875
Nausea 314.71 22.38 456 7338 704942 49892388
Vomiting 203.94 22.38 298 7496 460460 50136870
Diabetic ketoacidosis 149.89 22.38 67 7727 17805 50579525
Euglycaemic diabetic ketoacidosis 110.42 22.38 33 7761 2786 50594544
Weight decreased 80.09 22.38 131 7663 221114 50376216
Diarrhoea 63.24 22.38 216 7578 588260 50009070
Heart sounds 60.72 22.38 15 7779 615 50596715
Prolonged expiration 58.71 22.38 15 7779 706 50596624
Decreased appetite 53.36 22.38 104 7690 200819 50396511
Dehydration 53.35 22.38 89 7705 152360 50444970
Glycosylated haemoglobin increased 53.24 22.38 28 7766 10578 50586752
Cholelithiasis 52.77 22.38 45 7749 37928 50559402
Cholecystitis 51.45 22.38 30 7764 13841 50583489
Inappropriate schedule of product administration 50.97 22.38 59 7735 71772 50525558
Drug ineffective 50.86 22.38 32 7762 819301 49778029
Diabetic retinopathy 49.84 22.38 17 7777 2193 50595137
Blood glucose increased 49.63 22.38 58 7736 71266 50526064
Mesenteric panniculitis 47.83 22.38 9 7785 97 50597233
Retinopathy 46.44 22.38 17 7777 2695 50594635
Thyroid mass 45.97 22.38 18 7776 3430 50593900
Flank pain 42.49 22.38 26 7768 13089 50584241
Eructation 42.12 22.38 21 7773 7100 50590230
Pancreatic carcinoma 41.77 22.38 20 7774 6194 50591136
Ketoacidosis 40.47 22.38 17 7777 3878 50593452
Depressive symptom 40.19 22.38 16 7778 3184 50594146
Abdominal pain 39.81 22.38 102 7692 236126 50361204
Sleep disorder due to a general medical condition 38.54 22.38 20 7774 7351 50589979
Blood glucose decreased 36.98 22.38 27 7767 18184 50579146
Drug titration error 36.78 22.38 10 7784 600 50596730
Product dispensing error 35.02 22.38 20 7774 8871 50588459
Off label use 34.31 22.38 154 7640 474272 50123058
Myoglobinuria 34.18 22.38 8 7786 260 50597070
Lipase increased 33.07 22.38 19 7775 8522 50588808
Nasal congestion 32.96 22.38 40 7754 51080 50546250
Maculopathy 32.42 22.38 12 7782 1962 50595368
Product communication issue 31.70 22.38 8 7786 358 50596972
Respiration abnormal 30.04 22.38 15 7779 5087 50592243
Injection site extravasation 29.88 22.38 17 7777 7484 50589846
Drug dose titration not performed 29.82 22.38 8 7786 456 50596874
Pneumonia 29.08 22.38 11 7783 378390 50218940
Gastrointestinal disorder 28.88 22.38 52 7742 94404 50502926
Pancreatitis acute 28.62 22.38 26 7768 23786 50573544
COVID-19 27.65 22.38 35 7759 46627 50550703
Appetite disorder 27.48 22.38 15 7779 6099 50591231
Lactic acidosis 26.37 22.38 29 7765 33326 50564004
Vision blurred 26.24 22.38 45 7749 78602 50518728
Impaired gastric emptying 25.00 22.38 16 7778 8702 50588628
Urethral caruncle 24.51 22.38 5 7789 84 50597246
Productive cough 24.32 22.38 35 7759 52659 50544671
Urine calcium/creatinine ratio increased 23.02 22.38 5 7789 115 50597215
Medullary thyroid cancer 22.78 22.38 5 7789 121 50597209
Hypoglycaemia 22.43 22.38 34 7760 53547 50543783

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Nausea 554.11 28.31 445 5182 288810 29280090
Vomiting 536.65 28.31 386 5241 211874 29357026
Pancreatitis 382.29 28.31 167 5460 34347 29534553
Diarrhoea 210.04 28.31 284 5343 332414 29236486
Diabetic ketoacidosis 146.35 28.31 68 5559 16005 29552895
Euglycaemic diabetic ketoacidosis 114.28 28.31 35 5592 2595 29566305
Eructation 111.43 28.31 38 5589 3968 29564932
Weight decreased 89.91 28.31 126 5501 150779 29418121
Retinopathy 87.04 28.31 26 5601 1769 29567131
Abdominal pain 86.59 28.31 117 5510 135240 29433660
Gastrointestinal disorder 73.11 28.31 53 5574 28653 29540247
Cholecystitis acute 72.76 28.31 30 5597 5289 29563611
Constipation 68.88 28.31 96 5531 114064 29454836
Glycosylated haemoglobin increased 67.92 28.31 34 5593 9392 29559508
Decreased appetite 51.55 28.31 96 5531 145246 29423654
Necrotising myositis 46.62 28.31 12 5615 469 29568431
Blood glucose increased 45.42 28.31 56 5571 58928 29509972
Pancreatitis acute 44.56 28.31 37 5590 24348 29544552
Vision blurred 44.33 28.31 46 5581 40130 29528770
Diabetic retinopathy 43.77 28.31 15 5612 1587 29567313
Obstructive pancreatitis 43.01 28.31 11 5616 419 29568481
Neuropathy vitamin B12 deficiency 42.79 28.31 7 5620 23 29568877
Abdominal discomfort 40.99 28.31 48 5579 47855 29521045
Abdominal distension 40.96 28.31 47 5580 45864 29523036
Bile duct stone 38.85 28.31 15 5612 2227 29566673
Gastrooesophageal reflux disease 38.27 28.31 38 5589 31458 29537442
Pancreatic carcinoma 37.87 28.31 21 5606 7129 29561771
Lipase increased 37.48 28.31 22 5605 8315 29560585
Flatulence 36.85 28.31 29 5598 17680 29551220
Cholelithiasis 33.41 28.31 28 5599 18644 29550256
Cholecystitis 32.97 28.31 21 5606 9176 29559724
Dyspepsia 30.56 28.31 33 5594 30092 29538808

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Nausea 545.16 21.09 650 9903 785150 63703029
Vomiting 513.72 21.09 533 10020 550584 63937595
Pancreatitis 326.88 21.09 170 10383 59437 64428742
Diabetic ketoacidosis 234.91 21.09 109 10444 29736 64458443
Euglycaemic diabetic ketoacidosis 215.35 21.09 65 10488 5345 64482834
Diarrhoea 208.32 21.09 399 10154 722305 63765874
Eructation 112.95 21.09 46 10507 9145 64479034
Weight decreased 108.90 21.09 179 10374 285560 64202619
Decreased appetite 98.89 21.09 170 10383 281119 64207060
Glycosylated haemoglobin increased 94.29 21.09 48 10505 15971 64472208
Abdominal pain 91.00 21.09 174 10379 312201 64175978
Cholelithiasis 85.62 21.09 66 10487 45440 64442739
Cholecystitis acute 81.63 21.09 39 10514 11321 64476858
Heart sounds 60.47 21.09 15 10538 588 64487591
Pancreatitis acute 59.30 21.09 52 10501 42803 64445376
Cholecystitis 56.69 21.09 37 10516 19599 64468580
Dehydration 56.05 21.09 115 10438 216648 64271531
Prolonged expiration 55.84 21.09 15 10538 808 64487371
Bile duct stone 54.67 21.09 23 10530 4955 64483224
Blood glucose increased 53.79 21.09 73 10480 98000 64390179
Constipation 52.74 21.09 116 10437 229221 64258958
Drug ineffective 48.55 21.09 40 10513 840207 63647972
Pancreatic carcinoma 46.68 21.09 26 10527 10347 64477832
Necrotising myositis 45.49 21.09 13 10540 881 64487298
Obstructive pancreatitis 44.59 21.09 12 10541 651 64487528
Sleep disorder due to a general medical condition 43.63 21.09 23 10530 8211 64479968
Flatulence 42.89 21.09 40 10513 35626 64452553
Neuropathy vitamin B12 deficiency 42.01 21.09 7 10546 32 64488147
Lactic acidosis 41.98 21.09 51 10502 61359 64426820
Vision blurred 41.79 21.09 62 10491 90254 64397925
Mesenteric panniculitis 39.70 21.09 9 10544 238 64487941
Lipase increased 38.81 21.09 26 10527 14376 64473803
Ketoacidosis 38.74 21.09 20 10533 6843 64481336
Retinopathy 38.47 21.09 16 10537 3349 64484830
Hypoglycaemia 37.76 21.09 59 10494 89833 64398346
Abdominal pain upper 37.36 21.09 86 10467 174944 64313235
Inappropriate schedule of product administration 36.60 21.09 59 10494 92227 64395952
Dyspepsia 35.54 21.09 54 10499 80258 64407921
Death 34.54 21.09 18 10535 482687 64005492
Diabetic retinopathy 34.16 21.09 14 10539 2825 64485354
Depressive symptom 34.02 21.09 16 10537 4480 64483699
Flank pain 33.79 21.09 25 10528 16164 64472015
Pneumonia 33.03 21.09 26 10527 559550 63928629
Drug titration error 31.91 21.09 10 10543 930 64487249
Blood glucose decreased 31.86 21.09 28 10525 23095 64465084
Vitamin B12 decreased 31.35 21.09 13 10540 2702 64485477
Vitreous haemorrhage 29.74 21.09 13 10540 3072 64485107
Abdominal distension 29.71 21.09 55 10498 95939 64392240
Thyroid mass 29.22 21.09 13 10540 3204 64484975
Maculopathy 28.98 21.09 12 10541 2484 64485695
Product communication issue 28.96 21.09 8 10545 479 64487700
Nasal congestion 27.65 21.09 41 10512 59617 64428562
Product label confusion 27.24 21.09 7 10546 317 64487862
Acute kidney injury 26.58 21.09 144 10409 449096 64039083
Asthma 26.32 21.09 52 10501 95173 64393006
COVID-19 26.30 21.09 42 10511 65098 64423081
Respiration abnormal 26.17 21.09 15 10538 6300 64481879
Thrombocytopenia 26.17 21.09 3 10550 223798 64264381
Appetite disorder 25.85 21.09 15 10538 6446 64481733
Urethral caruncle 24.80 21.09 5 10548 74 64488105
Myoglobinuria 23.28 21.09 8 10545 992 64487187
Rales 22.10 21.09 19 10534 15210 64472969
Drug dose titration not performed 22.08 21.09 7 10546 676 64487503
Urine calcium/creatinine ratio increased 21.68 21.09 5 10548 143 64488036
Gastrooesophageal reflux disease 21.30 21.09 44 10509 83099 64405080

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A10BJ06 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Glucagon-like peptide-1 (GLP-1) analogues
FDA CS M0160181 Glucagon-Like Peptide 1
FDA MoA N0000020058 Glucagon-like Peptide-1 (GLP-1) Agonists
FDA EPC N0000178480 GLP-1 Receptor Agonist
CHEBI has role CHEBI:35526 antidiabetic
CHEBI has role CHEBI:63726 neuroprotective agents
CHEBI has role CHEBI:71196 GLP-1 receptor agonist
CHEBI has role CHEBI:74518 anti-obestic agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Diabetes mellitus type 2 indication 44054006 DOID:9352
Weight loss indication 89362005




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.23 acidic
pKa2 3.31 acidic
pKa3 3.71 acidic
pKa4 3.97 acidic
pKa5 4.22 acidic
pKa6 4.53 acidic
pKa7 4.76 acidic
pKa8 9.65 acidic
pKa9 12.06 acidic
pKa10 12.28 acidic
pKa11 12.41 acidic
pKa12 12.5 acidic
pKa13 12.63 acidic
pKa14 12.76 acidic
pKa15 12.95 acidic
pKa16 12.98 acidic
pKa17 13.11 acidic
pKa18 13.18 acidic
pKa19 13.24 acidic
pKa20 13.3 acidic
pKa21 13.4 acidic
pKa22 13.51 acidic
pKa23 13.61 acidic
pKa24 13.66 acidic
pKa25 13.73 acidic
pKa26 13.77 acidic
pKa27 13.83 acidic
pKa28 13.87 acidic
pKa29 13.94 acidic
pKa30 11.05 Basic
pKa31 10.45 Basic
pKa32 7.88 Basic
pKa33 5.98 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
2MG/1.5ML (1.34MG/ML) OZEMPIC NOVO N209637 Dec. 5, 2017 RX SOLUTION SUBCUTANEOUS 8536122 March 20, 2026 OZEMPIC IS INDICATED AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS
4MG/3ML (1.34MG/ML) OZEMPIC NOVO N209637 April 9, 2019 RX SOLUTION SUBCUTANEOUS 8536122 March 20, 2026 OZEMPIC IS INDICATED AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS
8MG/3ML (2.68MG/ML) OZEMPIC NOVO N209637 March 28, 2022 RX SOLUTION SUBCUTANEOUS 8536122 March 20, 2026 AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS
14MG RYBELSUS NOVO N213051 Sept. 20, 2019 RX TABLET ORAL 8536122 March 20, 2026 METHOD OF TREATING TYPE 2 DIABETES MELLITUS
3MG RYBELSUS NOVO N213051 Sept. 20, 2019 RX TABLET ORAL 8536122 March 20, 2026 METHOD OF TREATING TYPE 2 DIABETES MELLITUS
7MG RYBELSUS NOVO N213051 Sept. 20, 2019 RX TABLET ORAL 8536122 March 20, 2026 METHOD OF TREATING TYPE 2 DIABETES MELLITUS
2MG/1.5ML (1.34MG/ML) OZEMPIC NOVO N209637 Dec. 5, 2017 RX SOLUTION SUBCUTANEOUS 8129343 Dec. 5, 2031 OZEMPIC IS INDICATED AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS
4MG/3ML (1.34MG/ML) OZEMPIC NOVO N209637 April 9, 2019 RX SOLUTION SUBCUTANEOUS 8129343 Dec. 5, 2031 OZEMPIC IS INDICATED AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS
8MG/3ML (2.68MG/ML) OZEMPIC NOVO N209637 March 28, 2022 RX SOLUTION SUBCUTANEOUS 8129343 Dec. 5, 2031 AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS
14MG RYBELSUS NOVO N213051 Sept. 20, 2019 RX TABLET ORAL 8129343 Dec. 5, 2031 METHOD OF TREATING TYPE 2 DIABETES MELLITUS
3MG RYBELSUS NOVO N213051 Sept. 20, 2019 RX TABLET ORAL 8129343 Dec. 5, 2031 METHOD OF TREATING TYPE 2 DIABETES MELLITUS
7MG RYBELSUS NOVO N213051 Sept. 20, 2019 RX TABLET ORAL 8129343 Dec. 5, 2031 METHOD OF TREATING TYPE 2 DIABETES MELLITUS
14MG RYBELSUS NOVO N213051 Sept. 20, 2019 RX TABLET ORAL 9278123 Dec. 16, 2031 METHOD OF TREATING TYPE 2 DIABETES MELLITUS
3MG RYBELSUS NOVO N213051 Sept. 20, 2019 RX TABLET ORAL 9278123 Dec. 16, 2031 METHOD OF TREATING TYPE 2 DIABETES MELLITUS
7MG RYBELSUS NOVO N213051 Sept. 20, 2019 RX TABLET ORAL 9278123 Dec. 16, 2031 METHOD OF TREATING TYPE 2 DIABETES MELLITUS
2MG/1.5ML (1.34MG/ML) OZEMPIC NOVO N209637 Dec. 5, 2017 RX SOLUTION SUBCUTANEOUS 10335462 June 21, 2033 A METHOD OF TREATING TYPE 2 DIABETES COMPRISING ADMINISTERING SEMAGLUTIDE ONCE WEEKLY IN A AMOUNT OF 1.0 MG TO A SUBJECT IN NEED THEREOF
4MG/3ML (1.34MG/ML) OZEMPIC NOVO N209637 April 9, 2019 RX SOLUTION SUBCUTANEOUS 10335462 June 21, 2033 A METHOD OF TREATING TYPE 2 DIABETES COMPRISING ADMINISTERING SEMAGLUTIDE ONCE WEEKLY IN A AMOUNT OF 1.0 MG TO A SUBJECT IN NEED THEREOF
0.25MG/0.5ML (0.25MG/0.5ML) WEGOVY NOVO N215256 June 4, 2021 RX SOLUTION SUBCUTANEOUS 9764003 June 21, 2033 METHOD FOR WEIGHT MANAGEMENT ACCORDING TO A DOSE ESCALATION SCHEDULE
0.5MG/0.5ML (0.5MG/0.5ML) WEGOVY NOVO N215256 June 4, 2021 RX SOLUTION SUBCUTANEOUS 9764003 June 21, 2033 METHOD FOR WEIGHT MANAGEMENT ACCORDING TO A DOSE ESCALATION SCHEDULE
1.7MG/0.75ML (1.7MG/0.75ML) WEGOVY NOVO N215256 June 4, 2021 RX SOLUTION SUBCUTANEOUS 9764003 June 21, 2033 METHOD FOR WEIGHT MANAGEMENT ACCORDING TO A DOSE ESCALATION SCHEDULE
1MG/0.5ML (1MG/0.5ML) WEGOVY NOVO N215256 June 4, 2021 RX SOLUTION SUBCUTANEOUS 9764003 June 21, 2033 METHOD FOR WEIGHT MANAGEMENT ACCORDING TO A DOSE ESCALATION SCHEDULE
2.4MG/0.75ML (2.4MG/0.75ML) WEGOVY NOVO N215256 June 4, 2021 RX SOLUTION SUBCUTANEOUS 9764003 June 21, 2033 METHOD FOR WEIGHT MANAGEMENT ACCORDING TO A DOSE ESCALATION SCHEDULE
14MG RYBELSUS NOVO N213051 Sept. 20, 2019 RX TABLET ORAL 10278923 May 2, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS
3MG RYBELSUS NOVO N213051 Sept. 20, 2019 RX TABLET ORAL 10278923 May 2, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS
7MG RYBELSUS NOVO N213051 Sept. 20, 2019 RX TABLET ORAL 10278923 May 2, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS
0.25MG/0.5ML (0.25MG/0.5ML) WEGOVY NOVO N215256 June 4, 2021 RX SOLUTION SUBCUTANEOUS 10888605 Aug. 24, 2038 METHOD FOR WEIGHT MANAGEMENT
0.5MG/0.5ML (0.5MG/0.5ML) WEGOVY NOVO N215256 June 4, 2021 RX SOLUTION SUBCUTANEOUS 10888605 Aug. 24, 2038 METHOD FOR WEIGHT MANAGEMENT
1.7MG/0.75ML (1.7MG/0.75ML) WEGOVY NOVO N215256 June 4, 2021 RX SOLUTION SUBCUTANEOUS 10888605 Aug. 24, 2038 METHOD FOR WEIGHT MANAGEMENT
1MG/0.5ML (1MG/0.5ML) WEGOVY NOVO N215256 June 4, 2021 RX SOLUTION SUBCUTANEOUS 10888605 Aug. 24, 2038 METHOD FOR WEIGHT MANAGEMENT
2.4MG/0.75ML (2.4MG/0.75ML) WEGOVY NOVO N215256 June 4, 2021 RX SOLUTION SUBCUTANEOUS 10888605 Aug. 24, 2038 METHOD FOR WEIGHT MANAGEMENT

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
14MG RYBELSUS NOVO N213051 Sept. 20, 2019 RX TABLET ORAL Sept. 20, 2022 NEW PRODUCT
3MG RYBELSUS NOVO N213051 Sept. 20, 2019 RX TABLET ORAL Sept. 20, 2022 NEW PRODUCT
7MG RYBELSUS NOVO N213051 Sept. 20, 2019 RX TABLET ORAL Sept. 20, 2022 NEW PRODUCT
2MG/1.5ML (1.34MG/ML) OZEMPIC NOVO N209637 Dec. 5, 2017 RX SOLUTION SUBCUTANEOUS Dec. 5, 2022 NEW CHEMICAL ENTITY
4MG/3ML (1.34MG/ML) OZEMPIC NOVO N209637 April 9, 2019 RX SOLUTION SUBCUTANEOUS Dec. 5, 2022 NEW CHEMICAL ENTITY
8MG/3ML (2.68MG/ML) OZEMPIC NOVO N209637 March 28, 2022 RX SOLUTION SUBCUTANEOUS Dec. 5, 2022 NEW CHEMICAL ENTITY
14MG RYBELSUS NOVO N213051 Sept. 20, 2019 RX TABLET ORAL Dec. 5, 2022 NEW CHEMICAL ENTITY
3MG RYBELSUS NOVO N213051 Sept. 20, 2019 RX TABLET ORAL Dec. 5, 2022 NEW CHEMICAL ENTITY
7MG RYBELSUS NOVO N213051 Sept. 20, 2019 RX TABLET ORAL Dec. 5, 2022 NEW CHEMICAL ENTITY
0.25MG/0.5ML (0.25MG/0.5ML) WEGOVY NOVO N215256 June 4, 2021 RX SOLUTION SUBCUTANEOUS Dec. 5, 2022 NEW CHEMICAL ENTITY
0.5MG/0.5ML (0.5MG/0.5ML) WEGOVY NOVO N215256 June 4, 2021 RX SOLUTION SUBCUTANEOUS Dec. 5, 2022 NEW CHEMICAL ENTITY
1.7MG/0.75ML (1.7MG/0.75ML) WEGOVY NOVO N215256 June 4, 2021 RX SOLUTION SUBCUTANEOUS Dec. 5, 2022 NEW CHEMICAL ENTITY
1MG/0.5ML (1MG/0.5ML) WEGOVY NOVO N215256 June 4, 2021 RX SOLUTION SUBCUTANEOUS Dec. 5, 2022 NEW CHEMICAL ENTITY
2.4MG/0.75ML (2.4MG/0.75ML) WEGOVY NOVO N215256 June 4, 2021 RX SOLUTION SUBCUTANEOUS Dec. 5, 2022 NEW CHEMICAL ENTITY
2MG/1.5ML (1.34MG/ML) OZEMPIC NOVO N209637 Dec. 5, 2017 RX SOLUTION SUBCUTANEOUS Jan. 16, 2023 REDUCE THE RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS (CARDIOVASCULAR DEATH, NON-FATAL MYOCARDIAL INFARCTION OR NON-FATAL STROKE) IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE
4MG/3ML (1.34MG/ML) OZEMPIC NOVO N209637 April 9, 2019 RX SOLUTION SUBCUTANEOUS Jan. 16, 2023 REDUCE THE RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS (CARDIOVASCULAR DEATH, NON-FATAL MYOCARDIAL INFARCTION OR NON-FATAL STROKE) IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE
14MG RYBELSUS NOVO N213051 Sept. 20, 2019 RX TABLET ORAL Jan. 16, 2023 ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME
3MG RYBELSUS NOVO N213051 Sept. 20, 2019 RX TABLET ORAL Jan. 16, 2023 ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME
7MG RYBELSUS NOVO N213051 Sept. 20, 2019 RX TABLET ORAL Jan. 16, 2023 ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME
0.25MG/0.5ML (0.25MG/0.5ML) WEGOVY NOVO N215256 June 4, 2021 RX SOLUTION SUBCUTANEOUS June 4, 2024 NEW PRODUCT
0.5MG/0.5ML (0.5MG/0.5ML) WEGOVY NOVO N215256 June 4, 2021 RX SOLUTION SUBCUTANEOUS June 4, 2024 NEW PRODUCT
1.7MG/0.75ML (1.7MG/0.75ML) WEGOVY NOVO N215256 June 4, 2021 RX SOLUTION SUBCUTANEOUS June 4, 2024 NEW PRODUCT
1MG/0.5ML (1MG/0.5ML) WEGOVY NOVO N215256 June 4, 2021 RX SOLUTION SUBCUTANEOUS June 4, 2024 NEW PRODUCT
2.4MG/0.75ML (2.4MG/0.75ML) WEGOVY NOVO N215256 June 4, 2021 RX SOLUTION SUBCUTANEOUS June 4, 2024 NEW PRODUCT
8MG/3ML (2.68MG/ML) OZEMPIC NOVO N209637 March 28, 2022 RX SOLUTION SUBCUTANEOUS March 28, 2025 ADDITION OF A 3RD MAINTENANCE DOSE OF SEMAGLUTIDE

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Glucagon-like peptide 1 receptor GPCR AGONIST IC50 9.42 SCIENTIFIC LITERATURE DRUG LABEL

External reference:

IDSource
53AXN4NNHX UNII
C3885068 UMLSCUI
CHEBI:167574 CHEBI
CHEMBL2108724 ChEMBL_ID
56843331 PUBCHEM_CID
DB13928 DRUGBANK_ID
D10025 KEGG_DRUG
9724 IUPHAR_LIGAND_ID
1991302 RXNORM
304634 MMSL
325192 MMSL
33346 MMSL
d08688 MMSL
764283003 SNOMEDCT_US
764284009 SNOMEDCT_US
4037164 VANDF
017424 NDDF
C000591245 MESH_SUPPLEMENTAL_RECORD_UI
9113 INN_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Ozempic HUMAN PRESCRIPTION DRUG LABEL 1 0169-4130 INJECTION, SOLUTION 1.34 mg SUBCUTANEOUS NDA 30 sections
Ozempic HUMAN PRESCRIPTION DRUG LABEL 1 0169-4130 INJECTION, SOLUTION 1.34 mg SUBCUTANEOUS NDA 30 sections
Ozempic HUMAN PRESCRIPTION DRUG LABEL 1 0169-4132 INJECTION, SOLUTION 1.34 mg SUBCUTANEOUS NDA 30 sections
Ozempic HUMAN PRESCRIPTION DRUG LABEL 1 0169-4132 INJECTION, SOLUTION 1.34 mg SUBCUTANEOUS NDA 30 sections
Ozempic HUMAN PRESCRIPTION DRUG LABEL 1 0169-4136 INJECTION, SOLUTION 1.34 mg SUBCUTANEOUS NDA 30 sections
Ozempic HUMAN PRESCRIPTION DRUG LABEL 1 0169-4136 INJECTION, SOLUTION 1.34 mg SUBCUTANEOUS NDA 30 sections
RYBELSUS HUMAN PRESCRIPTION DRUG LABEL 1 0169-4303 TABLET 3 mg ORAL NDA 29 sections
RYBELSUS HUMAN PRESCRIPTION DRUG LABEL 1 0169-4307 TABLET 7 mg ORAL NDA 29 sections
RYBELSUS HUMAN PRESCRIPTION DRUG LABEL 1 0169-4314 TABLET 14 mg ORAL NDA 29 sections
WEGOVY HUMAN PRESCRIPTION DRUG LABEL 1 0169-4501 INJECTION, SOLUTION 1 mg SUBCUTANEOUS NDA 31 sections
WEGOVY HUMAN PRESCRIPTION DRUG LABEL 1 0169-4505 INJECTION, SOLUTION 0.50 mg SUBCUTANEOUS NDA 31 sections
WEGOVY HUMAN PRESCRIPTION DRUG LABEL 1 0169-4517 INJECTION, SOLUTION 1.70 mg SUBCUTANEOUS NDA 31 sections
WEGOVY HUMAN PRESCRIPTION DRUG LABEL 1 0169-4524 INJECTION, SOLUTION 2.40 mg SUBCUTANEOUS NDA 31 sections
WEGOVY HUMAN PRESCRIPTION DRUG LABEL 1 0169-4525 INJECTION, SOLUTION 0.25 mg SUBCUTANEOUS NDA 31 sections
Ozempic HUMAN PRESCRIPTION DRUG LABEL 1 0169-4772 INJECTION, SOLUTION 2.68 mg SUBCUTANEOUS NDA 30 sections
Ozempic HUMAN PRESCRIPTION DRUG LABEL 1 50090-5138 INJECTION, SOLUTION 1.34 mg SUBCUTANEOUS NDA 29 sections
Ozempic HUMAN PRESCRIPTION DRUG LABEL 1 50090-5139 INJECTION, SOLUTION 1.34 mg SUBCUTANEOUS NDA 29 sections
WEGOVY HUMAN PRESCRIPTION DRUG LABEL 1 50090-5824 INJECTION, SOLUTION 0.25 mg SUBCUTANEOUS NDA 31 sections
Ozempic HUMAN PRESCRIPTION DRUG LABEL 1 50090-5949 INJECTION, SOLUTION 1.34 mg SUBCUTANEOUS NDA 30 sections
Ozempic HUMAN PRESCRIPTION DRUG LABEL 1 70518-2143 INJECTION, SOLUTION 1.34 mg SUBCUTANEOUS NDA 28 sections