FYARRO
Peaksirolimus
NDAINTRAVENOUSPOWDERPriority Review
Approved
Nov 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Mechanism of Action
mTOR Inhibitors
Pharmacologic Class:
mTOR Inhibitor Immunosuppressant
Clinical Trials (5)
SARC046: A Phase II Trial of Nab-Sirolimus in Patients With Progressing or Symptomatic Epithelioid Hemangioendothelioma
Started Feb 2026
41 enrolled
Epithelioid Hemangioendothelioma (EHE)
Safety and Effectiveness of the Orsiro Mission 48-mm Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
Started Jul 2025
150 enrolled
Coronary Artery Disease
A Phase 2, Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-022 (Sirolimus) Topical Gel 3.9% in the Treatment of Cutaneous Venous Malformations
Started Dec 2024
15 enrolled
Cutaneous Venous Malformations
Selution Sirolimus-eluting Balloon for Internal Pudendal-penile Artery Disease-related Erectile Dysfunction
Started Sep 2022
54 enrolled
Erectile DysfunctionPeripheral Arterial DiseaseArterial Stenosis
Intravitreal Sirolimus as Therapeutic Approach to Uveitis
Started Sep 2022
0UveitisIntermediate UveitisPosterior Uveitis+1 more
Loss of Exclusivity
LOE Date
Oct 28, 2040
178 months away
Patent Expiry
Oct 28, 2040
Exclusivity Expiry
Nov 22, 2028