Public record

Semaglutide: the public record

20 tables from US federal sources. Latest data date: Nov 11, 2026.

Each table is computed from the named federal dataset as of its data date; the method is under each one.

Label

FDA label facts for semaglutide

The FDA label read for semaglutide (OZEMPIC, application NDA213051) was last revised on 2026-01-30. It carries a boxed warning headed "WARNING: RISK OF THYROID C-CELL TUMORS". Of the 4 population sections checked, 4 are present: pregnancy, lactation, pediatric use, geriatric use.

FDA label facts for semaglutide: the figures
MeasureValueNote
Label revision date2026-01-30
Label readOZEMPICNDA213051, brand-name application
Boxed warningYesheading as printed: "WARNING: RISK OF THYROID C-CELL TUMORS"
Pregnancy sectionPresent
Lactation sectionPresent
Pediatric use sectionPresent
Geriatric use sectionPresent

Source: FDA drug label via openFDA, viewable on NIH DailyMed, data as of Nov 11, 2026

How this was calculated

Selected the most recently revised prescription label for this single ingredient from an original manufacturer, preferring a brand-name application. Checked which sections exist and quoted headings and sentences exactly as printed.

Scope: One label: the newest prescription label for single-ingredient semaglutide from an original manufacturer, not specific to Wegovy

Read from one label. Labels for other brands, strengths or forms of the same ingredient can differ. A missing section heading does not mean there is no guidance. Read the full label before relying on it.

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Approvals

FDA approval history for semaglutide

The earliest FDA approval on file for a semaglutide product is 2017-12-05. Drugs@FDA lists 6 applications for it and 47 approved supplements, the most recent on 2026-08-27.

FDA approval history for semaglutide: the figures
MeasureValueNote
Earliest FDA approval on file2017-12-05
Applications with an approval on file6
New drug applications (NDA)5
Generic applications (ANDA)1
Approved supplements47label, manufacturing and efficacy changes
Most recent supplement approval2026-08-27
Sponsoring companies3

Source: FDA, Drugs@FDA, data as of Nov 11, 2026

How this was calculated

Selected applications with a product whose only active ingredient is this substance, then counted approved original and supplemental submissions. The earliest approved original submission is the first approval.

Scope: Applications with a single-ingredient semaglutide product in Drugs@FDA, all sponsors and strengths

Older approvals can be missing dates, and tentative approvals are not counted. An approved application does not mean the product is currently marketed.

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Patents and generics

Patents and generic approvals for semaglutide

The FDA Orange Book lists 0 approved generic applications for semaglutide across 29 listed products. 30 listed patents have not yet expired, the last on 2041-02-17.

Patents and generic approvals for semaglutide: the figures
MeasureValueNote
Brand-name applications (NDA)4
Approved generic applications (ANDA)0
Listed patents not yet expired30
Latest listed patent expiry2041-02-17
Latest listed exclusivity expiry2029-03-19exclusivity code NS
Earliest approval date on file2017-12-05
Products not marked discontinued28 of 29

Source: FDA, Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations), data as of Oct 9, 2026

How this was calculated

Selected Orange Book products whose only active ingredient is this substance, then counted applications by type and the distinct patents and exclusivities listed against them. Expired patents are left out.

Scope: All single-ingredient semaglutide products in the Orange Book, every brand and strength, files dated 2026-10-09

An approved generic or an expired patent does not show that a generic is on sale. Launch timing also depends on litigation, settlements and supply. Biologics and compounded products are not in the Orange Book.

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Medicare Part D

Medicare Part D claims for semaglutide by age group

Of 11,876,226 Medicare Part D claims for semaglutide in 2024, 9,247,488 (77.9%) were for enrollees aged 65 and over and 2,628,738 were for enrollees under 65.

Medicare Part D claims for semaglutide by age group: the figures
MeasureValueNote
All Part D claims, 202411,876,226
Claims for enrollees aged 65 and over9,247,488
Claims for enrollees under 652,628,738mostly people who qualify through disability
Share of claims for enrollees aged 65 and over77.9%share of claims, not of patients

Source: CMS, Medicare Part D Prescribers by Geography and Drug, data as of 2024

How this was calculated

Summed the national rows for every brand and generic row with this generic name. Claims under 65 are total claims minus claims for enrollees 65 and over.

Scope: National Part D claims for single-ingredient semaglutide products, 2024, split at age 65

Medicare mostly covers people 65 and over, so this split describes Medicare enrollees and not use in the general population.

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Medicare Part D

Medicare Part D claims for semaglutide by state

California had the most Medicare Part D claims for semaglutide in 2024 (1,176,301), followed by Texas (1,023,411) and New York (837,399). Prescribers in 59 states and territories wrote 11,876,178 claims in all.

Medicare Part D claims for semaglutide by state: the figures
MeasureValueNote
All states and territories, 202411,876,178 claims
States and territories with reported claims59
California1,176,301 claims$1.36B gross drug cost
Texas1,023,411 claims$1.35B gross drug cost
New York837,399 claims$1.10B gross drug cost
Florida815,754 claims$1.06B gross drug cost
Pennsylvania538,950 claims$674.4M gross drug cost

Source: CMS, Medicare Part D Prescribers by Geography and Drug, data as of 2024

How this was calculated

Summed claims and drug cost by prescriber state over every brand and generic row with this generic name. Combination products excluded. Rows CMS suppressed for small counts are left out.

Scope: Part D claims for single-ingredient semaglutide products by the prescriber's state, 2024; all brands, not only Ozempic

State counts follow population size and where the prescriber practises. They are not per-person rates and do not show any state's coverage rules.

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Medicare Part D

Medicare Part D spending on semaglutide

Medicare Part D spending on semaglutide products was $15.16B in 2024 across 11,880,490 claims, compared with $10.86B in 2023 (+39.6%). Average spending per claim was $1,276, before rebates.

Medicare Part D spending on semaglutide: the figures
MeasureValueNote
Total spending, 2024$15.16B
Total spending, 2023$10.86B
Change in spending, 2023 to 2024+39.6%
Claims (prescription fills), 202411,880,490
Average spending per claim, 2024$1,276
Ozempic: spending, 2024$12.97B10,417,182 claims
Rybelsus: spending, 2024$1.89B1,251,733 claims
Wegovy: spending, 2024$301.3M211,575 claims

Source: CMS, Medicare Part D Spending by Drug, data as of 2024

How this was calculated

Summed total spending and claims over every brand and generic row with this generic name in the CMS file, using the Overall manufacturer rows. Combination products excluded. Average per claim is spending divided by claims.

Scope: Every single-ingredient semaglutide product in Part D (Ozempic, Rybelsus, Wegovy), 2024. Not limited to Wegovy.

Gross drug cost before manufacturer rebates, so net cost is lower. Part D excludes some uses by law (for example erectile dysfunction, weight loss and hair growth), so claims reflect covered uses only. Compounded products are not included.

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Medicaid

Medicaid prescriptions for semaglutide by state

State Medicaid programmes paid for 5,889,063 semaglutide prescriptions in 2025, with $6.61B reimbursed before rebates. California reported the most (2,000,880), followed by New York (488,820) and Pennsylvania (485,053); 52 states and territories reported any.

Medicaid prescriptions for semaglutide by state: the figures
MeasureValueNote
Prescriptions paid by Medicaid, 20255,889,063
Total reimbursed before rebates, 2025$6.61B
States and territories reporting52with at least one count CMS did not suppress
California2,000,880 prescriptions$2.33B reimbursed
New York488,820 prescriptions$579.2M reimbursed
Pennsylvania485,053 prescriptions$573.2M reimbursed
North Carolina363,890 prescriptions$454.8M reimbursed
Michigan284,140 prescriptions$344.0M reimbursed

Source: CMS, Medicaid State Drug Utilization Data 2025, data as of 2025

How this was calculated

Matched each Medicaid product code to the FDA NDC Directory by labeler and product code, kept finished single-ingredient products, then summed prescriptions and reimbursement by state. National roll-up and suppressed rows dropped.

Scope: All single-ingredient semaglutide products in the FDA NDC Directory, fee-for-service and managed care, 2025

Counts under 11 are suppressed by CMS and left out, so totals are a floor. Amounts are before rebates. Differences between states reflect programme size and coverage rules. Compounded products are not included.

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Pharmacy cost

Pharmacy acquisition cost (NADAC) for semaglutide

Retail pharmacies paid an average of $332.02 per mL for OZEMPIC 0.25-0.5 MG/DOSE (2 MG/3 ML) PEN as of 2026-11-11, compared with $322.33 twelve months earlier (+3.0%). This is a pharmacy purchase cost, not a patient price.

Pharmacy acquisition cost (NADAC) for semaglutide: the figures
MeasureValueNote
OZEMPIC 0.25-0.5 MG/DOSE (2 MG/3 ML) PEN$332.02 per mL12 months earlier $322.33 (+3.0%)
OZEMPIC 1 MG/DOSE (4 MG/3 ML) PEN$331.94 per mL12 months earlier $322.31 (+3.0%)
OZEMPIC 2 MG/DOSE (8 MG/3 ML) PEN$332.00 per mL12 months earlier $322.25 (+3.0%)
OZEMPIC 1.5 MG TABLET$33.15 per unitno price on file 12 months earlier
OZEMPIC 4 MG TABLET$33.19 per unitno price on file 12 months earlier
OZEMPIC 9 MG TABLET$33.19 per unitno price on file 12 months earlier

Source: CMS, National Average Drug Acquisition Cost (NADAC), data as of Nov 11, 2026

How this was calculated

Matched NADAC product codes to the FDA NDC Directory, kept finished single-ingredient products, and listed the product descriptions with the most package codes. The earlier price is the same package code in the file one year before.

Scope: Brand-name product of semaglutide in the weekly NADAC file of 2026-11-11, compared with the file of 2025-11-12

NADAC is the average invoice price retail pharmacies pay, from a voluntary survey. It leaves out rebates, dispensing fees and markups, and it is not what a patient or insurer pays. Compounded products are not surveyed.

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Adverse event reports

FDA adverse event reports naming burping and semaglutide

Through 2026-10-28, FDA had received 1,524 adverse event reports for semaglutide that name burping (eructation), out of 111,027 reports for the drug in all. 894 of these reports concerned female patients and 531 male patients.

FDA adverse event reports naming burping and semaglutide: the figures
MeasureValueNote
Reports naming burping (eructation)1,524
All reports for semaglutide111,027
Share of this drug's reports naming it1.4%share of reports received, not of people taking the drug
Of those: female patients894reflects who takes the drug and who files reports
Of those: male patients531
Of those: sex not recorded99

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, data as of Oct 28, 2026

How this was calculated

Counted FAERS reports listing this active substance and at least one of these reaction terms: eructation. A report can name several reactions and several drugs. Counts by year use the date FDA received the report.

Scope: Reports where FDA recorded semaglutide as a single-ingredient active substance (any brand, not only Ozempic), MedDRA term eructation

FAERS reports are unverified and do not prove the drug caused the event. Reporting rises with use, publicity and lawsuits, so these counts cannot give rates or risks and cannot be compared between drugs.

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Adverse event reports

FDA adverse event reports naming constipation and semaglutide

Through 2026-10-28, FDA had received 6,473 adverse event reports for semaglutide that name constipation, out of 111,027 reports for the drug in all. 4,213 of these reports concerned female patients and 1,771 male patients.

FDA adverse event reports naming constipation and semaglutide: the figures
MeasureValueNote
Reports naming constipation6,473
All reports for semaglutide111,027
Share of this drug's reports naming it5.8%share of reports received, not of people taking the drug
Of those: female patients4,213reflects who takes the drug and who files reports
Of those: male patients1,771
Of those: sex not recorded489

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, data as of Oct 28, 2026

How this was calculated

Counted FAERS reports listing this active substance and at least one of these reaction terms: constipation. A report can name several reactions and several drugs. Counts by year use the date FDA received the report.

Scope: Reports where FDA recorded semaglutide as a single-ingredient active substance (any brand, not only Wegovy), MedDRA term constipation

FAERS reports are unverified and do not prove the drug caused the event. Reporting rises with use, publicity and lawsuits, so these counts cannot give rates or risks and cannot be compared between drugs.

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Adverse event reports

FDA adverse event reports naming diarrhoea and semaglutide

Through 2026-10-28, FDA had received 8,785 adverse event reports for semaglutide that name diarrhoea, out of 111,027 reports for the drug in all. 5,159 of these reports concerned female patients and 2,917 male patients.

FDA adverse event reports naming diarrhoea and semaglutide: the figures
MeasureValueNote
Reports naming diarrhoea8,785
All reports for semaglutide111,027
Share of this drug's reports naming it7.9%share of reports received, not of people taking the drug
Of those: female patients5,159reflects who takes the drug and who files reports
Of those: male patients2,917
Of those: sex not recorded709

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, data as of Oct 28, 2026

How this was calculated

Counted FAERS reports listing this active substance and at least one of these reaction terms: diarrhoea. A report can name several reactions and several drugs. Counts by year use the date FDA received the report.

Scope: Reports where FDA recorded semaglutide as a single-ingredient active substance (any brand, not only Ozempic), MedDRA term diarrhoea

FAERS reports are unverified and do not prove the drug caused the event. Reporting rises with use, publicity and lawsuits, so these counts cannot give rates or risks and cannot be compared between drugs.

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Adverse event reports

FDA adverse event reports naming gallstones or gallbladder inflammation and semaglutide

Through 2026-10-28, FDA had received 1,382 adverse event reports for semaglutide that name gallstones or gallbladder inflammation, out of 111,027 reports for the drug in all. 852 of these reports concerned female patients and 417 male patients.

FDA adverse event reports naming gallstones or gallbladder inflammation and semaglutide: the figures
MeasureValueNote
Reports naming gallstones or gallbladder inflammation1,382
All reports for semaglutide111,027
Share of this drug's reports naming it1.2%share of reports received, not of people taking the drug
Of those: female patients852reflects who takes the drug and who files reports
Of those: male patients417
Of those: sex not recorded113

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, data as of Oct 28, 2026

How this was calculated

Counted FAERS reports listing this active substance and at least one of these reaction terms: cholelithiasis, cholecystitis, cholecystitis acute. A report can name several reactions and several drugs. Counts by year use the date FDA received the report.

Scope: Reports with semaglutide as a single-ingredient active substance (any brand), 3 MedDRA terms for gallstones or gallbladder inflammation

FAERS reports are unverified and do not prove the drug caused the event. Reporting rises with use, publicity and lawsuits, so these counts cannot give rates or risks and cannot be compared between drugs.

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Adverse event reports

FDA adverse event reports naming injection site reactions and semaglutide

Through 2026-10-28, FDA had received 2,506 adverse event reports for semaglutide that name injection site reactions, out of 111,027 reports for the drug in all. 1,811 of these reports concerned female patients and 525 male patients.

FDA adverse event reports naming injection site reactions and semaglutide: the figures
MeasureValueNote
Reports naming injection site reactions2,506
All reports for semaglutide111,027
Share of this drug's reports naming it2.3%share of reports received, not of people taking the drug
Of those: female patients1,811reflects who takes the drug and who files reports
Of those: male patients525
Of those: sex not recorded170

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, data as of Oct 28, 2026

How this was calculated

Counted FAERS reports listing this active substance and at least one of these reaction terms: injection site reaction, injection site pain, injection site erythema, injection site swelling, injection site pruritus. A report can name several reactions and several drugs. Counts by year use the date FDA received the report.

Scope: Reports with semaglutide as a single-ingredient active substance (any brand), 5 MedDRA terms for injection site reactions

FAERS reports are unverified and do not prove the drug caused the event. Reporting rises with use, publicity and lawsuits, so these counts cannot give rates or risks and cannot be compared between drugs.

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Adverse event reports

FDA adverse event reports naming low blood sugar and semaglutide

Through 2026-10-28, FDA had received 785 adverse event reports for semaglutide that name low blood sugar (hypoglycaemia), out of 111,027 reports for the drug in all. 492 of these reports concerned female patients and 214 male patients.

FDA adverse event reports naming low blood sugar and semaglutide: the figures
MeasureValueNote
Reports naming low blood sugar (hypoglycaemia)785
All reports for semaglutide111,027
Share of this drug's reports naming it0.7%share of reports received, not of people taking the drug
Of those: female patients492reflects who takes the drug and who files reports
Of those: male patients214
Of those: sex not recorded79

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, data as of Oct 28, 2026

How this was calculated

Counted FAERS reports listing this active substance and at least one of these reaction terms: hypoglycaemia. A report can name several reactions and several drugs. Counts by year use the date FDA received the report.

Scope: Reports where FDA recorded semaglutide as a single-ingredient active substance (any brand, not only Ozempic), MedDRA term hypoglycaemia

FAERS reports are unverified and do not prove the drug caused the event. Reporting rises with use, publicity and lawsuits, so these counts cannot give rates or risks and cannot be compared between drugs.

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Adverse event reports

FDA adverse event reports naming nausea and semaglutide

Through 2026-10-28, FDA had received 15,568 adverse event reports for semaglutide that name nausea, out of 111,027 reports for the drug in all. 10,572 of these reports concerned female patients and 3,718 male patients.

FDA adverse event reports naming nausea and semaglutide: the figures
MeasureValueNote
Reports naming nausea15,568
All reports for semaglutide111,027
Share of this drug's reports naming it14.0%share of reports received, not of people taking the drug
Of those: female patients10,572reflects who takes the drug and who files reports
Of those: male patients3,718
Of those: sex not recorded1,278

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, data as of Oct 28, 2026

How this was calculated

Counted FAERS reports listing this active substance and at least one of these reaction terms: nausea. A report can name several reactions and several drugs. Counts by year use the date FDA received the report.

Scope: Reports where FDA recorded semaglutide as a single-ingredient active substance (any brand, not only Ozempic), MedDRA term nausea

FAERS reports are unverified and do not prove the drug caused the event. Reporting rises with use, publicity and lawsuits, so these counts cannot give rates or risks and cannot be compared between drugs.

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Adverse event reports

FDA adverse event reports naming pancreatitis and semaglutide

Through 2026-10-28, FDA had received 2,201 adverse event reports for semaglutide that name pancreatitis, out of 111,027 reports for the drug in all. 1,147 of these reports concerned female patients and 872 male patients.

FDA adverse event reports naming pancreatitis and semaglutide: the figures
MeasureValueNote
Reports naming pancreatitis2,201
All reports for semaglutide111,027
Share of this drug's reports naming it2.0%share of reports received, not of people taking the drug
Of those: female patients1,147reflects who takes the drug and who files reports
Of those: male patients872
Of those: sex not recorded182

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, data as of Oct 28, 2026

How this was calculated

Counted FAERS reports listing this active substance and at least one of these reaction terms: pancreatitis, pancreatitis acute. A report can name several reactions and several drugs. Counts by year use the date FDA received the report.

Scope: Reports where FDA recorded semaglutide as a single-ingredient active substance (any brand, not only Ozempic), MedDRA terms pancreatitis, pancreatitis acute

FAERS reports are unverified and do not prove the drug caused the event. Reporting rises with use, publicity and lawsuits, so these counts cannot give rates or risks and cannot be compared between drugs.

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Adverse event reports

FDA adverse event reports naming vomiting and semaglutide

Through 2026-10-28, FDA had received 10,351 adverse event reports for semaglutide that name vomiting, out of 111,027 reports for the drug in all. 6,763 of these reports concerned female patients and 2,755 male patients.

FDA adverse event reports naming vomiting and semaglutide: the figures
MeasureValueNote
Reports naming vomiting10,351
All reports for semaglutide111,027
Share of this drug's reports naming it9.3%share of reports received, not of people taking the drug
Of those: female patients6,763reflects who takes the drug and who files reports
Of those: male patients2,755
Of those: sex not recorded833

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, data as of Oct 28, 2026

How this was calculated

Counted FAERS reports listing this active substance and at least one of these reaction terms: vomiting. A report can name several reactions and several drugs. Counts by year use the date FDA received the report.

Scope: Reports where FDA recorded semaglutide as a single-ingredient active substance (any brand, not only Wegovy), MedDRA term vomiting

FAERS reports are unverified and do not prove the drug caused the event. Reporting rises with use, publicity and lawsuits, so these counts cannot give rates or risks and cannot be compared between drugs.

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Adverse event reports

Most reported events in FDA adverse event reports for semaglutide

Through 2026-10-28, FDA had received 111,027 adverse event reports for semaglutide, 55,901 of them marked serious by the reporter. The symptom terms named most often were nausea (15,568), vomiting (10,351) and diarrhoea (8,785).

Most reported events in FDA adverse event reports for semaglutide: the figures
MeasureValueNote
All reports received111,027
Reports the reporter marked serious55,901death, hospitalisation, disability or similar outcome
Nausea15,568 reports
Vomiting10,351 reports
Diarrhoea8,785 reports
Constipation6,473 reports
Decreased appetite6,098 reports

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, data as of Oct 28, 2026

How this was calculated

Counted FAERS reports listing this active substance, then the reaction terms named most often. A report can name several reactions, and a term can describe the illness being treated and not an effect of the drug. Terms about product use or complaints rather than symptoms (for example off label use) were left out of the list.

Scope: Reports where FDA recorded semaglutide as a single-ingredient active substance (any brand), all years to 2026-10-28

FAERS reports are unverified and do not prove the drug caused the event. Reporting rises with use, publicity and lawsuits, so these counts cannot give rates or risks and cannot be compared between drugs.

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Recalls

FDA drug recalls naming semaglutide

FDA enforcement reports list 57 drug recall entries naming semaglutide from 2021 to 2026-10-14. 56 of them are for compounded or other unlisted products and 1 for products FDA lists under a label. The most common stated reason was lack of sterility assurance (30 of 57).

FDA drug recalls naming semaglutide: the figures
MeasureValueNote
Recall entries on record57
For products FDA lists under an approved or registered label1
For compounded or other unlisted products56matched by the name in the product description
Class I (most serious)0
Class II57
Class III0
Most recent recall reported2026-10-14
Most common stated reasonlack of sterility assurance30 of 57 entries

Source: FDA, Enforcement Reports (drug recalls) via openFDA, data as of Nov 10, 2026

How this was calculated

Counted enforcement report entries matched by FDA's listed active substance, or by the name in the product description where FDA lists none. Reasons were grouped by keywords in FDA's stated reason.

Scope: Recalls of single-ingredient semaglutide products, plus compounded or unlisted products whose description names it

Each recall covers specific lots from one firm and is not a statement about every product with this ingredient. One event can appear as several entries, one per product.

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Clinical studies

Registered clinical studies of semaglutide

ClinicalTrials.gov lists 802 registered studies that name semaglutide as an intervention as of 2026-11-11. Of these, 179 are recruiting, 356 are completed and 186 are phase 3 studies.

Registered clinical studies of semaglutide: the figures
MeasureValue
Registered studies802
Recruiting now179
Not yet recruiting107
Completed356
Terminated, withdrawn or suspended25
Phase 3 (including phase 2/3)186
Phase 2 (including phase 1/2)139
Phase 1125

Source: NIH National Library of Medicine, ClinicalTrials.gov, data as of Nov 11, 2026

How this was calculated

Searched the ClinicalTrials.gov intervention field for the name, downloaded every matching record and counted by overall status and phase. Combined phases are counted under the higher phase. Phase not applicable covers observational, device and behavioural studies.

Scope: Studies whose intervention field matches semaglutide, any condition, any country, all statuses

A registered study is not a result. Counts include studies where the drug is a comparator or background treatment, and studies that never finished or reported.

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Articles on Semaglutide