Rapamune
(Sirolimus)ApprovedSmall molecule
Sirolimus is used to prevent the body's immune system from rejecting transplanted kidneys. It's also used to treat a rare type of cancer called lymphangioleiomyomatosis (LAM).[2] Rapamune is currently approved and in use across 137 indications[4].[1]
Rapamune is one of 1573 small molecule programs targeting Lung Transplantation. It is currently in Approved.
137
Indications
428
Total Trials
31
Active Trials
1,572
Competitors
4
FDA Applications
NDA/BLA/ANDA regulatory filings
8
Patents
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 137 indications
Competition
Competitive Landscape
706 competitors in Breast Cancer
#DrugCompanyPhaseTrials
1Rapamune
PPrism Pharmaceuticals
Approved
Adenocard
AstellasPreclinical
Voltaren
NovartisPreclinical
Methylthioninium Chloride
PProvepharm SAS
Preclinical
Duragesic-100
CCephalon
Preclinical
MS Contin
HHikma Pharmaceuticals LLC
Preclinical
Duragesic
CCephalon
Preclinical
Tricor
JJagotec
Preclinical
Cortef
PPfizer's Upjohn has merged with Mylan to form Viatris Inc.
Preclinical
Recombinant Human Endostatin
PPeking University Third Hospital
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Kidney Transplant27 trials
Show 24 more trials
Safety of Immunosuppression Minimization in Children and Adolescents After Kidney Transplantation
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00768729·7 enrolled
Study Evaluating Conversion From Tacrolimus to Sirolimus in Stable Kidney Transplant Recipients Receiving Myfortic
Completed·—·Phase 4·NCT00713284·29 enrolled
Acute Graft Versus Host Disease6 trials
A Study Using Tacrolimus, Sirolimus and Bortezomib as Acute Graft Versus Host Disease (GVHD) Prophylaxis in Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation
Completed·—·Phase 1·NCT00670423·27 enrolled
Show 3 more trials
Graft Versus Host Disease5 trials
Tacrolimus, Sirolimus and Methotrexate as Graft Versus Host Disease Prophylaxis After Blood Stem Cell Transplantation
Completed·—·Phase 2·NCT00146614·105 enrolled
Show 2 more trials
Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant For Hematological Cancer
Completed·—·Phase 2·NCT00589563·32 enrolled
Immunosuppression5 trials
Stem Cell Transplantation4 trials
Sirolimus With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Un-Related Stem Cell Transplantation
Completed·—·Phase 2·NCT00144677·30 enrolled
Sirolimus With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Related Stem Cell Transplantation
Completed·—·Phase 2·NCT00144703·55 enrolled
110 more indications
Sickle Cell Disease4 trials
Sickle Cell Disease Transplant Using a Nonmyeloablative Approach for Patients With Anti-donor Red Cell Antibody
Recruiting·—·Phase 2·NCT06358638·12 enrolled
Addition of JSP191 (C-kit Antibody) to Nonmyeloablative Hematopoietic Cell Transplantation for Sickle Cell Disease and Beta-Thalassemia
Active, not recruiting·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 1/2·NCT05357482·40 enrolled
Nonmyeloablative Haploidentical Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Sickle Cell Disease
Active, not recruiting·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 1/2·NCT03077542·57 enrolled
Renal Transplant Recipients4 trials
Show 1 more trial
Liver Transplant4 trials
Non-Small Cell Lung Cancer3 trials
Hematologic Malignancies3 trials
Safety and Efficacy3 trials
Chronic Graft Versus Host Disease3 trials
Ixazomib in the Prophylaxis of Chronic Graft-versus-host Disease.
Active, not recruiting·FFundación Pública Andaluza para la gestión de la Investigación en Sevilla·Phase 1/2·NCT03225417·142 enrolled
An Open Label Phase II Trial of Topical Sirolimus for the Treatment of Refractory Oral Chronic Graft-versus-Host-Disease
Terminated·—·Phase 2·NCT02123966·10 enrolled
Type 1 Diabetes3 trials
Islet Transplantation for Type 1 Diabetes
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00014911·36 enrolled
Islet Transplantation in Type 1 Diabetes
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00434811·48 enrolled
Bladder Cancer2 trials
Age-Related Macular Degeneration2 trials
Islet Transplantation2 trials
B-Lymphocyte Immunotherapy in Islet Transplantation
Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00468442·2 enrolled
Transplantation2 trials
Multiple Myeloma2 trials
Treatment2 trials
Sirolimus Treatment Of Patients With SLE
Not yet recruiting·SState University of New York - Upstate Medical University·Phase 2·NCT04736953·220 enrolled
Hepatocellular Carcinoma2 trials
Prophylaxis2 trials
Acute Lymphoblastic Leukemia2 trials
Cemiplimab in AlloSCT/SOT Recipients With CSCC
Completed·—·Phase 1/2·NCT04339062·12 enrolled
Stem Cell Transplant2 trials
Donor Peripheral Stem Cell Transplant in Treating Patients With Advanced Hematologic Cancer or Other Disorders
Active, not recruiting·—·Phase 2·NCT00544115·260 enrolled
Renal Allograft Recipients2 trials
Phase II2 trials
SCD-Haplo: Phase II Study of HLA-Haploidentical SCT for Aggressive SCD
Terminated·—·Phase 2·NCT02013375·2 enrolled
Allograft2 trials
Efficacy and Safety2 trials
Solid Tumors2 trials
Malignant Peripheral Nerve Sheath Tumor2 trials
Pneumonia2 trials
Acute Myeloid Leukemia1 trial
Antiphospholipid Syndrome1 trial
Kidney Cancer1 trial
Randomized1 trial
Single Dose1 trial
Immunodeficiency1 trial
Chronic Lymphocytic Leukemia1 trial
Anemia1 trial
Haploidentical PBMC Transplant for Severe Congenital Anemias
Active, not recruiting·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 1/2·NCT00977691·23 enrolled
Phase 11 trial
Pilot Study1 trial
Alzheimer's Disease1 trial
Chemotherapy1 trial
Chronic Granulomatous Disease1 trial
Haploidentical Transplant for People With Chronic Granulomatous Disease Using Post Transplant Cyclophosphamide
Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT02282904·7 enrolled
Transplant Recipient1 trial
Idiopathic Pulmonary Fibrosis1 trial
Basal Cell Nevus Syndrome1 trial
Multiple Sclerosis1 trial
Treating Multiple Sclerosis With Sirolimus, an Immune System Suppressor
Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT00095329·14 enrolled
Tolerance1 trial
Belatacept Post Depletional Repopulation to Facilitate Tolerance
Completed·—·Phase 2·NCT00565773·40 enrolled
Nephropathy1 trial
Using mTOR Inhibitors in the Prevention of BK Nephropathy
Completed·—·N/A·NCT01649609·40 enrolled
Cholangiocarcinoma1 trial
Myelofibrosis1 trial
Ruxolitinib Phosphate and Chemotherapy Given Before and After Reduced Intensity Donor Stem Cell Transplant in Treating Patients With Myelofibrosis
Completed·—·Phase 1·NCT02917096·18 enrolled
Induction Therapy1 trial
Lymphangioleiomyomatosis1 trial
Cardiac Transplant1 trial
The Effect and Safety Profile of Thymoglobulin® in Primary Cardiac Transplant Recipients
Enrolling by invitation·—·Phase 2·NCT03292861·60 enrolled
Unresectable Solid Tumor1 trial
Sirolimus in Treating Patients With Metastatic or Unresectable Solid Tumors
Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT00368914·30 enrolled
Autoimmune Disease1 trial
Sirolimus for Autoimmune Disease of Blood Cells
Completed·—·Phase 1/2·NCT00392951·30 enrolled
Immune Suppression1 trial
Leukemia1 trial
Pilot Trial of Sirolimus/MEC in High Risk Acute Myelogenous Leukemia (AML)
Completed·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·N/A·NCT01184898·36 enrolled
Fed1 trial
Bioavailability Study of Sirolimus Tablets 2 mg Under Fed Condition
Completed·—·Phase 1·NCT02296762·36 enrolled
Skin Cancer1 trial
Prevention of Skin Cancer in High Risk Patients After Conversion to a Sirolimus-based Immunosuppressive Protocol
Terminated·—·Phase 4·NCT01797315·40 enrolled
Peripheral Blood Stem Cell Transplantation1 trial
Tacrolimus and Sirolimus as Prophylaxis After Allogenic Non-myeloablative Peripheral Blood Stem Cell Transplantation
Completed·—·Phase 2·NCT00282282·31 enrolled
COVID-191 trial
Efficacy and Safety of Sirolimus in COVID-19 Infection
Unknown status·—·Phase 2·NCT04461340·40 enrolled
Vascular Malformation1 trial
Primary Peritoneal Cancer1 trial
Refractory Solid Tumors1 trial
Adult1 trial
Desmoid-type fibromatosis1 trial
Total Body Irradiation1 trial
Hematopoietic Stem Cell Transplant1 trial
Standard of Care vs. Bortezomib in Graft-Versus Host Disease After Hematopoietic Stem Cell Transplant
Completed·—·Phase 2·NCT01754389·138 enrolled
Head and Neck Squamous Cell Carcinoma1 trial
Rapamycin Therapy in Head and Neck Squamous Cell Carcinoma
Completed·NNational Institute of Dental and Craniofacial Research (NIDCR)·Phase 1/2·NCT01195922·37 enrolled
Sturge-Weber syndrome1 trial
Trial of Sirolimus for Cognitive Impairment in Sturge-Weber Syndrome
Completed·—·Phase 2/3·NCT03047980·10 enrolled
TED1 trial
Sirolimus Effect on Hypertrophic Syndromes Related Gene PIK3CA
Completed·—·Phase 2·NCT02443818·16 enrolled
Patients With Solid Tumors1 trial
B-cell NHL1 trial
A Phase II Study of Allo-HCT for B-Cell NHL Using Zevalin, Fludarabine and Melphalan
Completed·—·Phase 2·NCT00577278·41 enrolled
Neurodevelopment1 trial
Allogeneic Hematopoietic Stem Cell Transplantation1 trial
Co-infusion of Treg-enriched Donor Lymphocytes With CD3-depleted Hematopoietic Stem Cell Graft to Prevent Graft-versus Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation Among Children With Hematologic Malignancies
Recruiting·FFederal Research Institute of Pediatric Hematology, Oncology and Immunology·Phase 2/3·NCT07366801·64 enrolled
Autosomal Dominant Polycystic Kidney Disease1 trial
Non-myeloablative Conditioning1 trial
Kaposiform Hemangioendothelioma1 trial
Gastro-Intestinal Disorder1 trial
Sirolimus for Eosinophil-Associated Gastrointestinal Disorders
Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT01814059·4 enrolled
Survival1 trial
Strategies to Improve Islet Survival
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00464555·5 enrolled
Unspecified6 trials
Bioavailability Study of Sirolimus Tablets 2 mg Under Fasting Condition
Completed·—·Phase 1·NCT02296749·60 enrolled
Regulatory
FDA Approval Timeline[5]
Sep 15, 1999
RAPAMUNE
NDA NDA021083
Jan 25, 2010
RAPAMUNE
NDA NDA021110
Nov 22, 2021
FYARRO
NDA NDA213312
Mar 22, 2022
HYFTOR
NDA NDA213478
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Rapamune drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Sirolimus. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
- [7]
Details
Drug Info
Quick Facts
- Mechanism of Action
- FK506-Binding Protein 1a Inhibitor[3]
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company
- PPrism Pharmaceuticals