"Tesamorelin cycle" is searched as if the drug came with an on-and-off schedule. It does not. The two current labels give a once-daily dose, and every published trial ran it every day, without breaks, for a fixed period — two weeks in the shortest, a year in the longest. What the trials add, and the cycle pages leave out, is what happened when it stopped: in the phase 3 extension, the visceral fat came back. This page lists each trial's duration, dose and stopping result, sets the circulating cycle figures against them, and works out what a course of each length comes to in vials (sources opened 2026-10-20). It reports; it suggests no course.
The labelled doses, the trial results and the units at each concentration are on the tesamorelin dosage page; the water arithmetic is on the tesamorelin reconstitution page.
Every trial ran it daily
| Trial (registration) | Who | Dose | Duration | After stopping |
|---|---|---|---|---|
| NCT00850564; NCT00795210 | Healthy men; HIV patients | 2 mg daily | 2 weeks | Not reported in the registry |
| SMART, NCT00257712 (Baker, Arch Neurol 2012, PMID 22869065) | 152 adults aged 55 to 87, 66 with mild cognitive impairment | 1 mg nightly, 30 minutes before bed | 20 weeks | Re-tested after a 10-week washout (week 30) |
| NCT06554717 (recruiting) | 100 adults with HIV, with home exercise | EGRIFTA WR 1.28 mg daily | 24 weeks (primary outcome) | — |
| Phase 3, NCT00123253 (Falutz, NEJM 2007, PMID 18057338) | 412 HIV patients with abdominal fat | 2 mg daily | 26 weeks | Continued in the extension below |
| Extension, NCT00608023 (Falutz, AIDS 2008, PMID 18690162) | Re-randomised at week 26 | 2 mg daily, or switched to placebo | Weeks 26 to 52 | Visceral fat reaccumulated on placebo |
| Second phase 3 (Falutz, JAIDS 2010, PMID 20101189) | 404 HIV patients | 2 mg daily | 6 months, then 6-month extension | Gains "rapidly lost" on placebo |
| NCT01263717 (Stanley, JAMA 2014, PMID 25038357) | 50 HIV patients | 2 mg daily | 6 months (registry adds 6 months open-label) | — |
| NCT02196831 (Stanley, Lancet HIV 2019, PMID 31611038) | HIV patients with fatty liver | 2 mg daily | 12 months | — |
| NCT03375788 | Adults with fatty liver | Registry lists the F4 formulation at 1.4 mg daily | 12 months (primary outcome) | — |
Twenty-four records came back for tesamorelin on ClinicalTrials.gov; the table holds those that state a duration and a dose. One more record, NCT07481734 (2 mg daily, first posted 2026), carries "Mock Study" in its title and is left out of the count.
What happened when it stopped
The phase 3 programme was designed to answer exactly this. After 26 weeks on 2 mg a day, people on tesamorelin were split: 154 continued, 50 were switched to placebo without being told. The continuers kept an 18% reduction in visceral fat at week 52. The switched group lost theirs — "Upon discontinuation of tesamorelin, VAT reaccumulated" — and the authors concluded that the effects "do not last beyond the duration of treatment" (PMID 18690162). The second phase 3 trial, run in 2007 and 2008, repeated the design and reported the same: the improvements over 6 months "were rapidly lost" in those switched to placebo (PMID 20101189).
That result runs against the logic usually given for cycling. A break is described online as a way to keep the drug working; the controlled data show the effect lasting through a year of continuous use and ending within months of a stop.
What the labels say about stopping
The EGRIFTA SV and EGRIFTA WR labels (openFDA versions effective 2026-07-29) set no course length and no off-weeks, but they do name the conditions under which stopping is considered — and none of them is a calendar. The clearest is IGF-1: the labels state that "the effects of prolonged elevations in IGF-1 levels are unknown", call for IGF-1 monitoring during therapy, and say to consider discontinuing in patients with persistent elevations above 3 standard deviation scores, "particularly if the efficacy response is not robust".
| Point in the trials (label, section 5.2) | IGF-1 above 2 SDS | IGF-1 above 3 SDS |
|---|---|---|
| After 26 weeks of EGRIFTA | 47% | 36% |
| End of treatment, among those on it for 52 weeks | 34% | 23% |
The labels add that the elevation was "seen as early as 13 weeks". The other stopping conditions they list are clinical rather than time-based: recurrent malignancy, a suspected hypersensitivity reaction, and acute critical illness. Both labels also state that the long-term cardiovascular safety of tesamorelin is not known. So where the online schedules stop on a date, the labels stop on a measurement — a monitored blood level and a judged response — and a fixed break every few weeks appears in neither.
The online cycle figures, against the record
The protocol pages this site read on 2026-09-18 for the dosage page cite 1 to 2 mg once daily — the label's figure — and then add a schedule the label does not have: five days on and two off, in three-month cycles. Other versions name 8 to 12 weeks on and 2 to 4 weeks off. Neither cites a study, and none could be found that tested them.
| Claim on protocol pages | What the record holds |
|---|---|
| 5 days on, 2 days off | Every trial gave it every day |
| 8 to 12 weeks on, then a break | Trials ran 2, 20, 24 and 26 weeks and 6 and 12 months, then stopped or continued |
| Breaks prevent desensitisation | Visceral fat −15.2% at 26 weeks and −18% at 52 weeks on continuous dosing; no comparison of cycled and continuous dosing exists |
| Effects persist after a cycle | Visceral fat reaccumulated after the switch to placebo |
The SMART trial's 10-week washout is the only break built into a published design, and it served as a measurement point: participants were re-tested after it to see what remained. It was not a rest between two courses.
What each length comes to in vials
| Duration | 1 mg daily (SMART) | 1.28 mg (EGRIFTA WR) | 1.4 mg (EGRIFTA SV) | 2 mg (phase 3) | 2 mg, 5 days a week |
|---|---|---|---|---|---|
| 2 weeks | 14 mg | 17.9 mg | 19.6 mg | 28 mg | 20 mg |
| 12 weeks | 84 mg | 107.5 mg | 117.6 mg | 168 mg | 120 mg |
| 20 weeks | 140 mg | 179.2 mg | 196 mg | 280 mg | 200 mg |
| 26 weeks | 182 mg | 233 mg | 254.8 mg | 364 mg | 260 mg |
| 52 weeks | 364 mg | 465.9 mg | 509.6 mg | 728 mg | 520 mg |
Divide by 10 for ten-milligram vials, or by 5 for five-milligram vials: 26 weeks at 2 mg is 36.4 ten-milligram vials. A daily 2 mg amount reads as 40 units at 5 mg/mL and 20 units at 10 mg/mL; any other combination is worked by the tesamorelin vial calculator. The labelled products differ from research vials in format: one EGRIFTA WR vial holds seven daily amounts.
What this page does not do
It does not suggest a duration, a schedule or a break. It reports the trial durations as published, the results reported when tesamorelin was stopped, and the totals each length implies. Tesamorelin is approved in the US only for reducing excess abdominal fat in adults with HIV and lipodystrophy; every trial above was run in a defined population under supervision. The injection procedure is on the tesamorelin injection page, its pairing with ipamorelin on tesamorelin vs ipamorelin, and the compound itself in Medibact's tesamorelin guide. Decisions about using it belong with a clinician.
Sources and dates
Opened 2026-10-20: openFDA drug label records for EGRIFTA SV and EGRIFTA WR (effective 2026-07-29; sections 5.1 to 5.7 and the Medication Guide); ClinicalTrials.gov v2 API, intervention "tesamorelin" (24 records; arms, interventions and primary-outcome time frames of NCT00850564, NCT00795210, NCT00257712, NCT06554717, NCT00123253, NCT00608023, NCT01263717, NCT02196831, NCT03375788 and NCT07481734); PubMed abstracts of PMIDs 18690162 (AIDS 2008), 20101189 (JAIDS 2010), 22869065 (Arch Neurol 2012), 25038357 (JAMA 2014) and 31611038 (Lancet HIV 2019). From this site's tesamorelin dosage page (read 2026-09-18): the EGRIFTA SV and WR label doses, the 26-week result of PMID 18057338 and the protocol-page figures. Totals and units by this site. Corrections go to the contact page.