Public record
Tesamorelin: the public record
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.
| Measure | Value | Note |
|---|---|---|
| Earliest FDA approval on file | 2010-11-10 | |
| Applications with an approval on file | 1 | |
| New drug applications (NDA) | 0 | |
| Generic applications (ANDA) | 0 | |
| Biologics applications (BLA) | 1 | |
| Approved supplements | 11 | label, manufacturing and efficacy changes |
| Most recent supplement approval | 2025-03-25 | |
| Sponsoring companies | 1 |
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.
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.
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.
| Measure | Value | Note |
|---|---|---|
| All Part D claims, 2024 | 4,746 | |
| Claims for enrollees aged 65 and over | 2,483 | |
| Claims for enrollees under 65 | 2,263 | mostly people who qualify through disability |
| Share of claims for enrollees aged 65 and over | 52.3% | share of claims, not of patients |
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.
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.
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.
| Measure | Value |
|---|---|
| Total spending, 2024 | $37.1M |
| Total spending, 2023 | $31.6M |
| Change in spending, 2023 to 2024 | +17.5% |
| Claims (prescription fills), 2024 | 4,746 |
| Average spending per claim, 2024 | $7,823 |
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.
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.
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).
| Measure | Value | Note |
|---|---|---|
| All reports received | 2,771 | |
| Reports the reporter marked serious | 533 | death, hospitalisation, disability or similar outcome |
| Injection site pain | 230 reports | |
| Arthralgia | 220 reports | |
| Injection site bruising | 155 reports | |
| Weight increased | 146 reports | |
| Peripheral swelling | 139 reports |
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.
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.
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.
| Measure | Value |
|---|---|
| Registered studies | 24 |
| Recruiting now | 3 |
| Not yet recruiting | 0 |
| Completed | 14 |
| Terminated, withdrawn or suspended | 7 |
| Phase 3 (including phase 2/3) | 2 |
| Phase 2 (including phase 1/2) | 10 |
| Phase 1 | 2 |
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.
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.
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.
| Measure | Value | Note |
|---|---|---|
| Papers indexed, all years | 96 | |
| Published 2016 to 2025 | 40 | |
| Published in 2025 | 4 | |
| Published in 2024 | 4 | |
| Busiest year since 2016 | 2021 | 6 papers |
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.
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.
Articles on Tesamorelin
- Egrifta (Tesamorelin) Adult Dosing for Ages 30 to 49: Complete Clinical Guide
- Egrifta (Tesamorelin) Evidence Base Graded by GRADE
- Egrifta (Tesamorelin): What to Expect, Week-by-Week First Month
- Egrifta (Tesamorelin) Mechanism of Action: Full Pathway Explained
- Egrifta (Tesamorelin) Missed-Dose Protocol
- Egrifta (Tesamorelin) Muscle Preservation Strategies: A Clinical Guide