Track rapamycin in Peptimes™
Rapamycin, also called sirolimus, is produced by the bacterium Streptomyces hygroscopicus and is an mTOR inhibitor immunosuppressant. It is the active ingredient in several FDA-approved prescription products. (Source: DailyMed label.)
Is rapamycin FDA-approved?
Yes, as specific products: Rapamune, generic sirolimus, Fyarro and Hyftor are FDA-approved for the uses in their labels, and they're prescription only.
Rapamycin
Also: sirolimus, AY-22989, RAPA
- Status label in the Peptimes Library
- FDA Approved
- Routes in Peptimes
- OralTopicalOther
- Updated
- 1 Nov 2026
US regulatory status
FDA approval belongs to each product below, for its route and the uses in its label. Label uses are shortened unless quoted.
Rapamune (sirolimus) oral solution and tablets
Oral
Prophylaxis of organ rejection in patients aged 13 years or older receiving renal transplants, and treatment of patients with lymphangioleiomyomatosis.
Source: Drugs@FDA, checked 1 Nov 2026
Generic sirolimus tablets and oral solution, from several manufacturers, with Rapamune as the reference product
Oral
As stated on each product's label (approved through abbreviated new drug applications, ANDAs).
Source: Drugs@FDA, checked 1 Nov 2026
Fyarro (sirolimus protein-bound particles for injectable suspension)
Intravenous
Adults with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).
Source: DailyMed label, checked 1 Nov 2026
Hyftor (sirolimus topical gel)
Topical
Facial angiofibroma associated with tuberous sclerosis in adults and children aged 6 and older.
Source: DailyMed label, checked 1 Nov 2026
Investigational
No, for the products and uses above.
Source: Drugs@FDA, checked 1 Nov 2026
What studies have looked at
Each point says who or what was studied and what the study reported, with its source and the date we checked it. These are findings from the sources cited, not advice or a promise of any result.
- In animals or the lab
In genetically mixed mice at three test sites, rapamycin started late in life extended median and maximal lifespan in both sexes; at 90% mortality, lifespan rose 14% in females and 9% in males.
Source: PMID 19587680, checked 1 Nov 2026
- In humans
A placebo-controlled pilot in 25 generally healthy adults aged 70 to 95: no changes in cognition, physical performance or self-rated health, but small, statistically significant falls in haemoglobin, haematocrit and other red-cell measures with rapamycin.
Source: PMID 29408453, checked 1 Nov 2026
- Review of studies
A 2024 systematic review of 19 studies in people found improvements in some ageing-related measures of the immune, cardiovascular and skin systems, and no significant effects on endocrine, muscle or neurological systems. People with age-related diseases had more infections and higher cholesterol.
Source: PMID 38310895, checked 1 Nov 2026
How to track it in Peptimes
Add rapamycin in My Protocols and set the schedule you already follow: days of the week, times of day and a start date. Peptimes never suggests an amount when you log or schedule a dose. Its Library entry shows the status label “FDA Approved”; the entries above give the products it applies to.
- Routes: oral, topical or Other. Choose the one that matches each dose.
- Logging: the amount you took, the route and how you feel.
- Injection sites: oral, topical and Other doses have no injection site to record.
- Reminders and history: reminders at your times, Dose History, the Calendar and CSV or JSON export work as described on the peptide tracker app page.
Peptimes is a tracking app, not medical advice. Talk to a licensed clinician about your treatment. Peptimes doesn’t sell rapamycin or any other compound.
More sources
- FDA, Drugs@FDA: NDA 021083 (Rapamune oral solution), NDA 021110 (Rapamune tablets), NDA 213312 (Fyarro) and NDA 213478 (Hyftor), checked 1 Nov 2026: product, route and marketing status.
- National Library of Medicine, DailyMed, sirolimus oral solution label, marketed under NDA 021083, checked 1 Nov 2026: section 1 (both uses) and section 11 (description).
- FDA, Global Substance Registration System, Sirolimus, checked 1 Nov 2026: its formula, C51H79NO13, and the names rapamycin, AY-22989 and RAPA.
Related pages
Brand names on this page are trademarks of their owners. Peptimes isn't affiliated with or endorsed by them.