Wednesday, July 8, 2026

Drug profile · INN

sirolimus

sirolimus (RAPAMUNE) is a fk506-binding protein 1a inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: topical. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved PMDA: approved Antineoplastic and immunomodulating agents (L04) L04AH01
US status approved
Patents linked 0
Pipeline programs 20
News articles 0
Drug details — sirolimus
US status
approved
Class
Antineoplastic and immunomodulating agents (L04)
Route
TOPICAL
Patents
0
Programs
20
Data quality
0.89

Quick answer

sirolimus (RAPAMUNE) is a fk506-binding protein 1a inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: topical. Current US regulatory status: approved.

Key facts

INN sirolimus
Brand RAPAMUNE
Mechanism FK506-binding protein 1A inhibitor
Target Peptidyl-prolyl cis-trans isomerase FKBP1A
Therapeutic class Antineoplastic and immunomodulating agents (L04)
Route TOPICAL
Formulation POWDER
ATC code L04AH01

Mechanism of action

FK506-binding protein 1A inhibitor

Primary target: Peptidyl-prolyl cis-trans isomerase FKBP1A

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
PMDA approved

Pipeline programs

  1. Sirolimus Phase 3 · Chinese Academy of · Lupus Nephritis
  2. Sirolimus Phase 3 · Ultragenyx UK · Lymphangioleiomyomatosis
  3. ALXN2350-DCM-201 Phase 2 · Alexion Europe SAS · BAG3 Mutation Associated Dilated Cardiomyopathy
  4. RP-A501-0123 Phase 2 · Anaxis Pharma · Danon Disease
  5. Rapamune 1 mg/mL oral solution Phase 2 · Tour Hekla · Lingual microcystic lymphatic malformations (LMLMs) are rare
  6. SIROLIMUS Phase 2 · PARItec · Adult patients (men and women) (≥ 18 years of age) with cuta
  7. SIROLIMUS, SIROLIMUS Phase 2 · Anaxis Pharma · Subjects diagnosed with port wine stains
  8. Sirolimus Phase 2 · Chinese Academy of · Hemangioendothelioma

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)

Frequently asked questions

What is sirolimus?

sirolimus (RAPAMUNE) is a fk506-binding protein 1a inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: topical. Current US regulatory status: approved.

What is the brand name for sirolimus?

RAPAMUNE is a marketed brand name for sirolimus. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of sirolimus?

sirolimus has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.