NDAORALTABLET
Approved
Aug 2000
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
108
Data completeness
4/8 — Partial
RAPAMUNE (sirolimus) by Pfizer is mtor inhibitors [moa]. First approved in 2000.
Drug data last refreshed 8h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RAPAMUNE (sirolimus) is an oral mTOR inhibitor immunosuppressant approved in 2000 for prevention of organ rejection in transplant patients. It works by inhibiting the mammalian target of rapamycin (mTOR), a key regulator of cell proliferation and immune activation. The drug is used primarily in renal transplant recipients to reduce acute rejection episodes.
$0.76MPart D
LOE ApproachingProduct is in late-stage lifecycle with declining market exclusivity; commercial teams are likely focused on defending market share against generics rather than growth initiatives.
Mechanism of Action
mTOR Inhibitors
Pharmacologic Class:
mTOR Inhibitor Immunosuppressant
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (108)
IVUS-Guided Sirolimus-Coated Balloon Versus Sirolimus-Eluting Stent for De Novo Large Vessel Lesions in ACS
Started Sep 2026
150 enrolled
Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)
Domatinostat With Sirolimus for Relapsed, Refractory Sarcoma and Osteosarcoma
Started Jul 2026
74 enrolled
SarcomaOsteosarcoma
A Multicenter, Prospective, Randomized Controlled Study Comparing Glucocorticoid Combined With Sirolimus With Monotherapy of Glucocorticoid in the Treatment of Newly Diagnosed Mild Autoimmune Hemolytic Anemia
Started Apr 2026
216 enrolled
Autoimmune Hemolytic Anemia (AIHA)
A Phase 2, Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-022 (Sirolimus) Topical Gel 3.9% in the Treatment of Angiokeratomas (LOTU)
Started Apr 2026
15 enrolled
Angiokeratomas
A Study Comparing the MAGICTouch™ Sirolimus-coated Balloon With a Paclitaxel-coated Balloon for Treating Severe Narrowing or Blockage in the Femoropopliteal Arteries.
Started Apr 2026
478 enrolled
Popliteal Artery DiseaseSuperficial Femoral Artery Disease
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.