Sirolimus

Generic Name
Sirolimus
Brand Names
Fyarro, Hyftor, Rapamune
Drug Type
Small Molecule
Chemical Formula
C51H79NO13
CAS Number
53123-88-9
Unique Ingredient Identifier
W36ZG6FT64
Background

Sirolimus, also known as rapamycin, is a macrocyclic lactone antibiotic produced by bacteria Streptomyces hygroscopicus, which was isolated from the soil of the Vai Atari region of Rapa Nui (Easter Island). It was first isolated and identified as an antifungal agent with potent anticandida activity; however, after its potent antitumor and immunosuppressive a...

Indication

Sirolimus is indicated for the prophylaxis of organ rejection in patients aged 13 years or older receiving renal transplants. In patients at low-to moderate-immunologic risk, it is recommended that sirolimus be used initially in a regimen with cyclosporine and corticosteroids; cyclosporine should be withdrawn two to four months after transplantation. In pati...

Associated Conditions
Chordomas, Facial Angiofibroma, Graft-versus-host Disease (GVHD), Heart Transplant Rejection, Liver Transplant Rejection, Lung Transplant Rejection, Lymphangioleiomyomatosis (LAM), Renal Angiomyolipomas, Transplanted Organ Rejection, Metastatic malignant Perivascular Epithelioid Cell Neoplasms, Unresectable, locally advanced malignant Perivascular Epithelioid Cell Neoplasms
Associated Therapies
-

Comparison of Sirolimus to Tacrolimus for Long Term Therapy in Kidney Transplant With no Steroids

Phase 1
Completed
Conditions
First Posted Date
2005-09-15
Last Posted Date
2012-07-31
Lead Sponsor
Mayo Clinic
Target Recruit Count
177
Registration Number
NCT00170053
Locations
🇺🇸

Mayo Clinic, Jacksonville, Florida, United States

A Trial of Two Steroid-Free Approaches Toward Mycophenolate Mofetil-Based Monotherapy Immunosuppression

First Posted Date
2005-09-14
Last Posted Date
2015-10-26
Lead Sponsor
Northwestern University
Target Recruit Count
40
Registration Number
NCT00166712
Locations
🇺🇸

Northwestern University/Northwestern Memorial Hospital, Chicago, Illinois, United States

Tacrolimus, Sirolimus and Methotrexate as Graft Versus Host Disease Prophylaxis After Blood Stem Cell Transplantation

First Posted Date
2005-09-07
Last Posted Date
2012-03-08
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
105
Registration Number
NCT00146614
Locations
🇺🇸

Beth Isreal Deaconess Medical Center, Boston, Massachusetts, United States

🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

Sirolimus With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Related Stem Cell Transplantation

First Posted Date
2005-09-05
Last Posted Date
2012-01-26
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
55
Registration Number
NCT00144703
Locations
🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Sirolimus With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Un-Related Stem Cell Transplantation

First Posted Date
2005-09-05
Last Posted Date
2012-01-26
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
30
Registration Number
NCT00144677
Locations
🇺🇸

Dana-Farber Cancer Center, Boston, Massachusetts, United States

Efficacy and Safety of Sirolimus in Combination With Tacrolimus

Phase 3
Conditions
First Posted Date
2005-09-01
Last Posted Date
2005-12-01
Lead Sponsor
University Hospital Muenster
Target Recruit Count
190
Registration Number
NCT00141804
Locations
🇩🇪

University Hospital Muenster, Muenster, Germany

Study Comparing Sirolimus With Cyclosporine in a Calcineurin Inhibitor (CNI)-Free Regimen in Kidney Transplant Recipients

Phase 3
Terminated
Conditions
First Posted Date
2005-08-29
Last Posted Date
2013-02-08
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
500
Registration Number
NCT00137345

TUMORAPA 1: Efficacy of Rapamycin in Secondary Prevention of Skin Cancers in Kidney Transplant Recipients

First Posted Date
2005-08-24
Last Posted Date
2014-07-02
Lead Sponsor
Hospices Civils de Lyon
Target Recruit Count
77
Registration Number
NCT00133887
Locations
🇫🇷

Hôpital Edouard Herriot - Service de Dermatologie, Lyon, France

Study of Unrelated Cord Blood Transplantation Using Tacrolimus and Sirolimus

First Posted Date
2005-08-23
Last Posted Date
2016-07-25
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
32
Registration Number
NCT00133367
Locations
🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

Study Evaluating the Effect of Sirolimus on Non-Melanoma Skin Cancer in Kidney Transplant Recipients

First Posted Date
2005-08-12
Last Posted Date
2012-04-11
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
86
Registration Number
NCT00129961
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