growth hormone releasing hormone analogue

Tesamorelin

US: FDA-approvedEU: Application withdrawnUK: Not on the registerCA: AuthorisedAU: Status unknownCH: Not on the registerBR: Not on the registerRS: Not on the registerSG: Not on the registerTR: Not on the register

Answer

Tesamorelin is authorised or registered in the US and Canada: 2 of the 10 registers read. No trial states a phase. It has 24 registered trials, 3 of them running. Brand names on the FDA label register: Egrifta Sv and Egrifta Wr.

RegulatorTrial register10 regulators' registers, read 2026-09-03 to 2026-10-03 · ClinicalTrials.gov, read 2026-10-03

Not medical, legal or regulatory advice.

Registered trials24Trial register ClinicalTrials.gov

Running now3Trial register recruiting, active or enrolling

Results posted8Trial register with results on the register

Stopped early29.2%Trial register all peptides: 10%

24 trials by status

Trial register

Running 3Completed 14Stopped early 7

ClinicalTrials.gov · read 2026-10-03 · 8 trials have posted results

Trials first submitted per year

Trial register

12011

32012

22013

12014

22015

12016

32017

12019

12024

12026

ClinicalTrials.gov first-submitted date, last 10 years · read 2026-10-03. 2026 is not complete. 8 trials carry no first-submitted date (EU CTIS publishes none, or the year is outside this range).

Status by jurisdiction

World map

CAISNOUSUKEUUACNKRJPMXCHLIRSTRINTHBREGILSAAESGARZAAUNZ

Authorised or registeredNot on the register, or withdrawnNot read yet, or status unknown

Where	Status	Register	Read
United States	FDA-approved	FDA, openfda	2026-10-03
European Union	Application withdrawn	EMA, ema	2026-10-03
United Kingdom	Not on the register	MHRA, uk-mhra	2026-09-03
Canada	Authorised	Health Canada, ca-dpd	2026-09-03
Australia	Status unknown	TGA, au-artg	not read
Switzerland	Not on the register	Swissmedic, ch-swissmedic	2026-09-03
Brazil	Not on the register	ANVISA, br-anvisa	2026-09-03
Serbia	Not on the register	ALIMS, rs-alims	2026-09-03
Singapore	Not on the register	HSA, sg-hsa	2026-09-03
Turkey	Not on the register	TITCK, tr-titck	2026-09-03

An EU decision applies in the 30 territories the EU register covers: its member states, and Iceland, Liechtenstein and Norway. A dashed tile has no register read for this peptide.

Side effects

Trial register

4 placebo-controlled trials · 220 people on Tesamorelin · grey is placebo

Injection site erythema6.8% 2.6%

Paresthesia2.4% 5%

Injection site pain1.8% 2.5%

Nephrolithiasis0.8% 0.5%

Abdominal pain0.6% 1.5%

ClinicalTrials.gov posted results · read 2026-10-03All side effects

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One email when the status of Tesamorelin changes on the register. You confirm your address first.

ENFORCEMENT AND OFFICIAL ACTIONS

1 action by named authorities

Enforcement actions, board positions and payer rules that name Tesamorelin, quoted from the source document. These are not approval decisions. This list shows the actions found so far. It is not a complete list: no authority publishes one.

US-OHenforcement

Ohio Board of Pharmacy, 2026-04-16

During the inspection, [redacted] was found to possess multiple vials of the following illegal dangerous drugs, in either a white powder, purple powder, or clear liquid form, intended for injection, which were obtained from an unlicensed, foreign source: t. Tesamorelin 10mg, 9 vials;

State of Ohio Board of Pharmacy, Order, Case No. A-2026-0037, Findings of Fact paragraph 2(t) · quoted with the party redacted

REGISTERED TRIALS

Newest 10 of 24 trials

All 24 trials

NCT03226821	Body Composition and Adipose Tissue in HIV terminated before completion · register updated 2026-05-19
NCT06554717	Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV currently recruiting participants · register updated 2026-05-19
NCT07481734	Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study) currently recruiting participants · register updated 2026-03-19
NCT02572323	Phase II Trial of Tesamorelin for Cognition in Aging HIV-Infected Persons completed · register updated 2026-03-12
NCT03375788	Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular Risk completed · register updated 2025-11-20
NCT03150511	Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury currently recruiting participants · register updated 2025-11-12
NCT00608023	TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy completed · register updated 2022-09-30
NCT03826160	Growth Hormone Dynamics and Cardiac Steatosis in HIV completed · register updated 2022-07-19
NCT01388920	Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting terminated before completion · register updated 2022-03-18
NCT02196831	Tesamorelin Effects on Liver Fat and Histology in HIV completed · register updated 2020-01-27

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