Drug
Sirolimus clinical trials
Also written Rapamycin, Rapamune, AY 22989 and SILA 9268A.
Related medicines add 1 study
Counted the way a researcher would: Sirolimus with its salts, dosage forms, brands and biosimilars. Looking for a trial to join? Including related medicines shows more you could take part in.
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How each study uses Sirolimus is sorted by a rule, right about nine times in ten. Readers can ask us to read every study one by one.Ask us to read each study
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Approvals
The first approval found in each region, with its record
- United States
- 15 Sept 1999 · RAPAMUNE · NDA 021083 (FDA, Drugs@FDA)
- European Union
- 13 Mar 2001 · Rapamune · EMEA/H/C/000273 (EMA)
From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out
How studies write it
Studies that test it under each name
Studies by the year they started
497 studies that test it; most in 2006 (33); 3 more planned to start later
| Year | Studies |
|---|---|
| 1996 | 2 |
| 1998 | 1 |
| 1999 | 1 |
| 2000 | 9 |
| 2001 | 7 |
| 2002 | 17 |
| 2003 | 7 |
| 2004 | 18 |
| 2005 | 21 |
| 2006 | 33 |
| 2007 | 27 |
| 2008 | 23 |
| 2009 | 20 |
| 2010 | 28 |
| 2011 | 20 |
| 2012 | 18 |
| 2013 | 15 |
| 2014 | 18 |
| 2015 | 16 |
| 2016 | 17 |
| 2017 | 21 |
| 2018 | 22 |
| 2019 | 11 |
| 2020 | 18 |
| 2021 | 18 |
| 2022 | 19 |
| 2023 | 9 |
| 2024 | 18 |
| 2025 | 21 |
| 2026 | 22 |
By phase
A phase 1/2 study counts in both.
What it is tested for
Each study’s main condition, where its own words name it, so a study counts once.
Who runs them
Industry 65 · Other 440
Wyeth is now a wholly owned subsidiary of Pfizer (22) · National Institute of Allergy and Infectious Diseases (NIAID) (18) · Mayo Clinic (12) · The University of Texas Health Science Center at San Antonio (10) · National Cancer Institute (NCI) (9) · University of Chicago (9) · Dana-Farber Cancer Institute (9) · Peking Union Medical College Hospital (9)
Often tested with
Tested in the same studies.
Tacrolimus (52) · Mycophenolic Acid (29) · Cyclophosphamide (28) · Cyclosporine (22) · Alemtuzumab (19) · Fludarabine (13) · Methotrexate (10) · Antilymphocyte Serum (9)
Related medicines
As reviewed, each with the page that says it.
- One of Immunosuppressive Agents source
- One of mTOR inhibitors source
- One of Protein Kinase Inhibitors source
Coming up
From the study records. Dates are the sponsors’ own estimates and often move.
Reaching primary completion within a year · 30, 7 in phase 3
Studies that test Sirolimus, phase 3 first.
- Dec 2026Assessing the Efficacy of Sirolimus in Patients With COVID-19 Pneumonia for Prevention of Post-COVID FibrosisPhase 2/3 · University of Chicago
- Dec 2026Different Doses of Sirolimus for the Treatment of Cystic Lymphatic MalformationsPhase 2/3 · West China Hospital
- Dec 2026Low Dose Sirolimus in People With Post-Acute Sequelae of COVID-19 (PASC) Long COVID-19Phase 3 · Icahn School of Medicine at Mount Sinai
- Jun 2027Co-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 MalignanciesPhase 2/3 · Federal Research Institute of Pediatric Hematology, Oncology and Immunology
- Sep 2027Topical Sirolimus in Chemoprevention of Facial Squamous Cell Carcinomas in Solid Organ Transplant Recipients (SiroSkin)Phase 3 · Melanoma and Skin Cancer Trials Limited
- Sep 2027Sirolimus in Patients With Systemic Lupus Erythematosus-Associated Immune ThrombocytopeniaPhase 2/3 · Chinese SLE Treatment And Research Group
- Nov 2027Systematic Approach for Children With Orbital Malformation With Sirolimus UsePhase 3 · Ain Shams University
- Dec 2026Cyclophosphamide and Sirolimus for the Treatment of Metastatic, RAI-refractory, Differentiated Thyroid CancerPhase 2 · University of Michigan Rogel Cancer Center
- Dec 2026The Safety and Efficiency of Sirolimus in Primary Antiphospholipid Syndrome: a Randomized Control StudyPhase 2 · Peking University People's Hospital
- Dec 2026Study of Sirolimus in IgG4-related DiseaseNot applicable · Peking University International Hospital
Studies
Open first, then newest update. How each study uses Sirolimus is read from its arms, and is right about nine times in ten. Ask us to read each study. These are the studies that list it as an intervention; a search of ClinicalTrials.gov also finds studies that mention it only in a description, such as earlier treatment.
Testing it · 505
- A Phase 1 Study of UB-VV500 With Rapamycin in Relapsed/Refractory Multiple MyelomaRecruitingPhase 1Umoja BiopharmaNCT07735546Written as Rapamycin (sirolimus)
- Haploidentical Donor Hematopoietic Cell Transplant for Sickle Cell DiseaseRecruitingPhase 2St. Jude Children's Research HospitalNCT07616154Written as Sirolimus
- The Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination With Sirolimus and Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Stem Cell TransplantationRecruitingPhase 1/2National Cancer Institute (NCI)NCT05436418Written as Sirolimus
- A Phase 1/2 Study of UB-VV400 With Rapamycin in Relapsed/Refractory B-cell MalignanciesRecruitingPhase 1/2Umoja BiopharmaNCT07735533Written as Rapamycin (sirolimus)
- A Pilot Study to Examine the Efficacy and Tolerability of Sirolimus on Epidermal Nevi Lesions in Patients 6 Years Old and Above.Not yet recruitingEarly Phase 1Northwestern UniversityNCT07813533Written as sirolimus topical gel 0.2%
- Study of ASP2957 in Male Participants With X-linked Myotubular Myopathy Who Need VentilatorsRecruitingPhase 1/2Astellas Gene TherapiesNCT07052929Written as Sirolimus
- Base Editing for Mutation Repair in Hematopoietic Stem & Progenitor Cells for X-Linked Chronic Granulomatous DiseaseRecruitingPhase 1/2National Institute of Allergy and Infectious Diseases (NIAID)NCT06325709Written as Sirolimus
- Rapamycin Dose-Ranging Efficacy Study in Port Wine StainsNot yet recruitingPhase 2AFT Pharmaceuticals, Ltd.NCT07436611Written as Rapamycin cream
- Advancing Transplantation Outcomes in ChildrenRecruitingPhase 2National Institute of Allergy and Infectious Diseases (NIAID)NCT06055608Written as Sirolimus
- Efficacy and Safety of Rapamycin Versus Vigabatrin in the Prevention of Tuberous Sclerosis Complex Symptoms in InfantsRecruitingPhase 2/3Katarzyna KotulskaNCT04987463Written as Rapamycin
- Immunotherapy With Baricitinib and Sirolimus, Alone and in Combination, for the Control of HIV-1 Replication After Antiretroviral Treatment InterruptionNot yet recruitingPhase 2ANRS, Emerging Infectious DiseasesNCT07081763Written as Sirolimus 2 MG
- A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell MalignanciesRecruitingPhase 1Umoja BiopharmaNCT06528301Written as rapamycin
- Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metastatic Skin CancerRecruitingPhase 1/2National Cancer Institute (NCI)NCT05896839Written as Sirolimus
- Low-Dose Sirolimus for the Treatment of RUNX1 Familial Platelet DisorderRecruitingPhase 1OHSU Knight Cancer InstituteNCT07844694Written as Sirolimus
- Effects of Sirolimus on Asymptomatic ApoE4 CarriersRecruitingPhase 1University of Missouri-ColumbiaNCT07728175Written as Sirolimus (rapamycin)
- Phase I/II Trial of Dinutuximab Beta in Combination With Irinotecan and Rapamycin in Pediatric, Adolescents and Adult Patients With Relapsed/Refractory Bone Tumors.Not yet recruitingPhase 1/2University Hospital, Strasbourg, FranceNCT07853105Written as Dinutuximab beta, Sirolimus and Irinotecan
- Sirolimus Discontinuation Strategies in Kaposiform HemangioendotheliomaRecruitingPhase 2West China HospitalNCT07131644Written as Sirolimus
- Intestinal & Multivisceral Transplantation for Unresectable Mucinous Carcinoma Peritonei (TRANSCAPE)Not yet recruitingPhase 2Case Comprehensive Cancer CenterNCT06084780Written as Sirolimus
- A Nutritional and Pharmacological Intervention for Body, Brain, and Longevity Effects (NIBBLE)Not yet recruitingPhase 1/2Cedars-Sinai Medical CenterNCT06682767Written as Rapamycin
- Low-Dose Sirolimus to Increase Hematopoietic Function in Patients With RUNX1 Familial Platelet DisorderRecruitingPhase 2M.D. Anderson Cancer CenterNCT06261060Written as Sirolimus
See all 505 studies that test Sirolimus →
Given beside what is tested · 88 — Sirolimus is usual care or a partner of the new treatment
- Study to Evaluate the Safety and Effectiveness of ELEVIDYS in Participants With Duchenne Muscular Dystrophy Treated in a Post-Marketing SettingRecruitingPhase 4Sarepta Therapeutics, Inc.NCT07542314Written as Sirolimus
- Donor Lymphocyte Infusion After Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic MalignanciesRecruitingPhase 1/2National Cancer Institute (NCI)NCT05327023Written as Sirolimus
- Phase I/II Study to Reduce Post-transplantation Cyclophosphamide Dosing for Older or Unfit Patients Undergoing Bone Marrow Transplantation for Hematologic MalignanciesRecruitingPhase 1/2National Cancer Institute (NCI)NCT04959175Written as Sirolimus
- 225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic SyndromeRecruitingPhase 1City of Hope Medical CenterNCT06287944Written as Sirolimus
- Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS)RecruitingPhase 2Fred Hutchinson Cancer CenterNCT03970096Written as Sirolimus
- Phase I Trial Integrating HLA-Haploidentical Anti-CD19 CAR-T Cells With Post-Transplantation Cyclophosphamide-Based HLA-Haploidentical Hematopoietic Cell TransplantationRecruitingPhase 1National Cancer Institute (NCI)NCT07162038Written as Sirolimus
- Cemiplimab for Kidney Transplant Recipients With Advanced Cutaneous Squamous Cell CarcinomaNot yet recruitingPhase 2Washington University School of MedicineNCT07715734Written as Sirolimus
- Allogeneic Hematopoietic Stem Cell Transplantation for Chronic Granulomatous Disease (CGD) With an Alemtuzumab, Busulfan and TBI-based Conditioning Regimen Combined With Cytokine (IL-6, +/- IFN-gamma) AntagonistsRecruitingPhase 1/2National Institute of Allergy and Infectious Diseases (NIAID)NCT05463133Written as Sirolimus
- Optimizing GVHD Prophylaxis After Allogeneic Hematopoietic Cell TransplantationRecruitingPhase 2University of NebraskaNCT06799195Written as Sirolimus
- Total Marrow and Lymphoid Irradiation in Combination With Fludarabine and Melphalan as Conditioning for Allogeneic Peripheral Blood Stem Cell Hematopoietic Cell Transplant in Older Patients With Refractory and Relapsed Acute Myeloid Leukemia and High-risk Myelodysplastic SyndromeRecruitingPhase 2City of Hope Medical CenterNCT07582172Written as Sirolimus
- A Phase 1/2 Study of Intravenous Gene Transfer With an AAV9 Vector Expressing Human Beta-galactosidase in Type I and Type II GM1 GangliosidosisRecruitingPhase 1/2National Human Genome Research Institute (NHGRI)NCT03952637Written as Sirolimus
- Cosibelimab for CSCC in Patients With Kidney Transplant or Hematologic MalignancyRecruitingPhase 4Dana-Farber Cancer InstituteNCT07426484Written as Sirolimus
- Total Body Irradiation and Astatine-211-Labeled BC8-B10 Monoclonal Antibody for the Treatment of Nonmalignant DiseasesRecruitingPhase 1/2Fred Hutchinson Cancer CenterNCT04083183Written as Sirolimus
- 131I-apamistamab-based Conditioning for Hematopoietic Stem Cell Transplant (HSCT) in Advanced Sickle Cell Disease (SCD)RecruitingPhase 1Columbia UniversityNCT07015684Written as Sirolimus
- A Study of Sirolimus (Albumin-Bound) in Combination With Different ADCs Treatment of Advanced Solid TumorsRecruitingPhase 1/2CSPC ZhongQi Pharmaceutical Technology Co., Ltd.NCT07241936Written as sirolimus (albumin-bound)
- Sickle Cell Disease Transplant Using a Nonmyeloablative Approach for Patients With Anti-donor Red Cell AntibodyRecruitingPhase 2Children's National Research InstituteNCT06358638Written as Sirolimus
- Efficacy and Safety of Sirolimus With or Without Cyclosporin A in Chinese Patients With Aplastic Anemia Refractory/Intolerant to Cyclosporin ARecruitingPhase 2Peking Union Medical College HospitalNCT06802055Written as Sirolimus (Rapamune®)
- Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic LeukemiaActive, not recruitingPhase 2National Cancer Institute (NCI)NCT00792948Written as Sirolimus
- Human Lysozyme Goat Milk for the Prevention of Graft Versus Host Disease in Patients With Blood Cancer Undergoing a Donor Stem Cell TransplantActive, not recruitingPhase 1City of Hope Medical CenterNCT04177004Written as Sirolimus
- Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic LeukemiaActive, not recruitingPhase 2City of Hope Medical CenterNCT01885689Written as sirolimus
Showing 20 of 88.
As the comparator · 6 — what is tested is compared with Sirolimus
- MTOR Inhibitors in Older AdultsRecruitingPhase 1/2University of Texas Southwestern Medical CenterNCT06727305Written as Sirolimus 0.5 Mg Oral Tablet
- Donor Regulatory T Cells Infusion in Patients With Chronic Graft-versus-host Disease (GVHD)TerminatedPhase 2University of LiegeNCT01903473Written as Rapamycin
- A Study of Metformin With or Without Rapamycin as Maintenance Therapy After Induction Chemotherapy in Subjects With Pancreatic CancerCompletedPhase 1Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsNCT02048384Written as rapamycin (Arm B)
- Open Label Comparative Study Of De Novo Renal Allograft Recipients Receiving CSA + MMF + Corticosteroids Versus CSA + Rapamune + CorticosteroidsCompletedPhase 4PfizerNCT01601821Written as CsA+Rapamune+CS
- Differentiating Everolimus Versus Sirolimus in Combination With Calcineurin Inhibitors in Kidney Transplant PatientsWithdrawnPhase 4University of Colorado, DenverNCT02062892Written as Sirolimus
- Liver Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Sirolimus in Recipients of a Liver TransplantCompletedPhase 4Hoffmann-La RocheNCT00118742Written as Sirolimus
What changed recently
From the registry's own updates since Oct 15, 2026.
Started recruiting1
- A Phase 1 Study of UB-VV500 With Rapamycin in Relapsed/Refractory Multiple MyelomaNov 13, 2026NCT07735546
Results posted1
- Tolerance by Engaging Antigen During Cellular HomeostasisOct 29, 2026NCT03504241
Codes
What other systems call Sirolimus · ClinicalTrials.gg INT008754
- MeSH (NLM) D020123SirolimusConfirmed ClinicalTrials.gov, NLM, Wikidata
- UNII (FDA) W36ZG6FT64SIROLIMUSConfirmed FDA, NLM, Wikidata
- RxNorm 35302Confirmed FDA, Wikidata
- Wikidata Q32089sirolimusConfirmed FDA, NLM, Wikidata
- NCI Thesaurus C1212SirolimusConfirmed FDA, Wikidata
- DrugBank DB00877One source Wikidata
| System | Code | Name there | Checked by |
|---|---|---|---|
| MeSH (NLM) | D020123 | Sirolimus | Confirmed ClinicalTrials.gov, NLM, Wikidata |
| UNII (FDA) | W36ZG6FT64 | SIROLIMUS | Confirmed FDA, NLM, Wikidata |
| RxNorm | 35302 | — | Confirmed FDA, Wikidata |
| Wikidata | Q32089 | sirolimus | Confirmed FDA, NLM, Wikidata |
| NCI Thesaurus | C1212 | Sirolimus | Confirmed FDA, Wikidata |
| DrugBank | DB00877 | — | One source Wikidata |
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.