Public record

Tesamorelin: the public record

6 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.

Approvals

FDA approval history for tesamorelin

The earliest FDA approval on file for a tesamorelin product is 2010-11-10. Drugs@FDA lists 1 application for it and 11 approved supplements, the most recent on 2025-03-25.

FDA approval history for tesamorelin: the figures
MeasureValueNote
Earliest FDA approval on file2010-11-10
Applications with an approval on file1
New drug applications (NDA)0
Generic applications (ANDA)0
Biologics applications (BLA)1
Approved supplements11label, manufacturing and efficacy changes
Most recent supplement approval2025-03-25
Sponsoring companies1

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 tesamorelin 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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Medicare Part D

Medicare Part D claims for tesamorelin by age group

Of 4,746 Medicare Part D claims for tesamorelin in 2024, 2,483 (52.3%) were for enrollees aged 65 and over and 2,263 were for enrollees under 65.

Medicare Part D claims for tesamorelin by age group: the figures
MeasureValueNote
All Part D claims, 20244,746
Claims for enrollees aged 65 and over2,483
Claims for enrollees under 652,263mostly people who qualify through disability
Share of claims for enrollees aged 65 and over52.3%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 tesamorelin 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 spending on tesamorelin

Medicare Part D spending on tesamorelin products was $37.1M in 2024 across 4,746 claims, compared with $31.6M in 2023 (+17.5%). Average spending per claim was $7,823, before rebates.

Medicare Part D spending on tesamorelin: the figures
MeasureValue
Total spending, 2024$37.1M
Total spending, 2023$31.6M
Change in spending, 2023 to 2024+17.5%
Claims (prescription fills), 20244,746
Average spending per claim, 2024$7,823

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 tesamorelin product in Part D (Egrifta Sv), 2024.

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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Adverse event reports

Most reported events in FDA adverse event reports for tesamorelin

Through 2026-10-28, FDA had received 2,771 adverse event reports for tesamorelin, 533 of them marked serious by the reporter. The symptom terms named most often were injection site pain (230), arthralgia (220) and injection site bruising (155).

Most reported events in FDA adverse event reports for tesamorelin: the figures
MeasureValueNote
All reports received2,771
Reports the reporter marked serious533death, hospitalisation, disability or similar outcome
Injection site pain230 reports
Arthralgia220 reports
Injection site bruising155 reports
Weight increased146 reports
Peripheral swelling139 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 product dose omission issue) were left out of the list.

Scope: Reports where FDA recorded tesamorelin 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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Clinical studies

Registered clinical studies of tesamorelin

ClinicalTrials.gov lists 24 registered studies that name tesamorelin as an intervention as of 2026-11-11. Of these, 3 are recruiting, 14 are completed and 2 are phase 3 studies.

Registered clinical studies of tesamorelin: the figures
MeasureValue
Registered studies24
Recruiting now3
Not yet recruiting0
Completed14
Terminated, withdrawn or suspended7
Phase 3 (including phase 2/3)2
Phase 2 (including phase 1/2)10
Phase 12

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 tesamorelin, 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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Published research

Published papers mentioning tesamorelin

PubMed indexes 96 papers that mention tesamorelin in the title or abstract, 40 of them published from 2016 to 2025. The count for 2025 is 4 and for 2024 is 4.

Published papers mentioning tesamorelin: the figures
MeasureValueNote
Papers indexed, all years96
Published 2016 to 202540
Published in 20254
Published in 20244
Busiest year since 201620216 papers

Source: NIH National Library of Medicine, PubMed, data as of Nov 11, 2026

How this was calculated

Ran a PubMed title and abstract search for the exact name variants shown and recorded the count for each publication year. No filtering by study type or quality.

Scope: PubMed records with 'tesamorelin' in the title or abstract, all article types and species

A paper that mentions a compound is not evidence that it works or is safe in people. Counts include animal, cell, review and opinion papers.

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Articles on Tesamorelin