Regulatory milestones approvals, filings & regulatory actions · 10 recorded
Milestone
Jurisdiction
Brand
Indication
Date
Sentence it was read from
Filedlung lymphangioleiomyomatosis1 milestone
Filed
US (FDA)
RAPAMUNE
lung lymphangioleiomyomatosis
2015-02-20
“has accepted for priority review a supplemental New Drug Application (sNDA)for RAPAMUNE® (sirolimus) for the treatment of lymphangioleiomyomatosis (LAM)” pfizer.com ↗
ApprovedIndication not stated4 milestones
Filed
China (NMPA)
—
—
2026-07-27
“NEW DRUG APPLICATION FOR SIROLIMUS FOR INJECTION (ALBUMIN- BOUND) ACCEPTED BY THE NMPA” irasia.com ↗
In the CRL, the FDA required that the Company provide additional data mainly related to manufacturing control strategy of the biological component of NASP and to address contract manufacturing facility deficiencies.
Zydus Lifesciences Limited (including its subsidiaries/affiliates hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) for Sirolimus Tablets, 1 mg and 2 mg (USRLD: Rapamune Tablets).
DRGT, a specialty pharmaceutical company, today announced the results of its Phase I study of DRGT18-2, a novel formulation of Sirolimus (Rapamune ® ), originally a Pfizer product approved by the FDA.
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved RAPAMUNE® (sirolimus) for the treatment of lymphangioleiomyomatosis (LAM), a rare, progressive disease that affects the lungs, kidneys and the lymphatic system.
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental New Drug Application (sNDA)for RAPAMUNE® (sirolimus) for the treatment of lymphangioleiomyomatosis (LAM), a rare, progressive lung disease in women of childbearing age that is often fatal.
REGiMMUNE Corporation today announced that its lead product candidate RGI-2001, in combination with a low-dose of Sirolimus, demonstrated enhanced efficacy in transplantation tolerance induction in models of skin transplantation and acute Graft-versus-Host disease (GvHD).
Every value below carries the sentence it was read from.
608 sources stand behind the page.
Field
Value
Cited text
Known as
Sirolimus
“The development of LAM-001 for lung transplant related BOS, conceptually a T-cell driven process against transplanted alloantigen, is based on the principal hypothesis that...” NCT06018766 ↗578
“The BAT in this study was identified by the investigator prior to patient randomization among the following treatments currently used in this setting: anti-thymocyte globulin...” NCT02913261 ↗
“The BAT in this study will freely be identified by the Investigator prior to patient randomization and may include treatments such as: anti-thymocyte globulin (ATG),...” NCT04118556 ↗
“Patients will receive the recommended phase 2 dose (RP2D) of SM-88 (460 mg by mouth [PO] twice a day [BID] D1 - 28) as well as three conditioning agents (MPS): methoxsalen (10...” NCT04720664 ↗
“High-dose, post-transplantation cyclophosphamide (PTCy) 25-50 mg/kg on days +3 and +4, sirolimus 6 mg on days +5 through +90, and mycophenolate mofetil (MMF) on days +5 through...” NCT02579967 ↗
“The trial evaluates the safety and efficacy of the Magic Touch PTA sirolimus drug-coated balloon in comparison to the treatment with PTX drug-coated balloon (control device) in...” NCT04475783 ↗
“Stepwise reduction in the dose, and ultimate discontinuation of, all non-belatacept immunosuppression (mycophenolate, sirolimus, everolimus, prednisone) guided by monitoring of...” NCT04177095 ↗
“LUMINA Phase III Study Assessing the Efficacy and Safety of Intravitreal Injections of 440 ug DE-109 Sirolimus for the Treatment of Active, Non-Infectious Uveitis of the...” NCT03711929 ↗
“Sirolimus 0.2 mg/kg loading dose, then 0.1 mg/kg p.o. daily adjusted to reach target trough levels of 10-15 ng/ml during the first 3 months post transplant and 7-10 ng/ml thereafter” NCT00679042 ↗
“The PK sub-study is being conducted to assess the blood pharmacokinetics of the three drugs (Sirolimus, Rivaroxaban, Argatroban) eluted from the DESyne BDS Plus after implantation.” NCT05033964 ↗
“Sirolimus (INN/USAN), also known as rapamycin, is an immunosuppressant drug used to prevent rejection in organ transplantation; it is especially useful in kidney transplants.” NCT01889992 ↗
“ABI-009 is a nanoparticle albumin-bound (nab®) formulation of the mammalian Target of Rapamycin ( mTOR) inhibitor, sirolimus.” NCT02009332 ↗
Known as
DE-109
“LUMINA Phase III Study Assessing the Efficacy and Safety of Intravitreal Injections of 440 ug DE-109 Sirolimus for the Treatment of Active, Non-Infectious Uveitis of the...” NCT03711929 ↗
“The purpose of this trial is to evaluate the safety and efficacy of long-term treatment with NPC-12G gel (0.2% sirolimus gel) to angiofibroma and other skin lesions in patients...” NCT02634931 ↗1
“NPC-12G gel (topical formulation of sirolimus)” NCT02635789 ↗
Known as
PTX-022
“This study evaluates the safety and efficacy of PTX-022 (sirolimus) Topical Gel 3.9% w/w in the treatment of Microcystic Lymphatic Malformations.” NCT05050149 ↗2
“PTX-022 (Sirolimus) Topical Gel 3.9%” NCT06653842 ↗
“PTX-022 (Sirolimus) Topical Gel 3.9%” NCT07552077 ↗
Known as
QTORIN Sirolimus
“Study Evaluating the Safety and Efficacy of PTX-022 (QTORIN Sirolimus) in the Treatment of Microcystic Lymphatic Malformations” NCT05050149 ↗
Known as
Rap
“the mTOR inhibitor sirolimus (Rap) found that administering the drug” NCT06719791 ↗
Known as
RAPA
“Evaluation of central nervous system penetration of orally administered Rapamune (RAPA) in older adults with Mild Cognitive Impairment (MCI) or early Alzheimer's disease (AD)...” NCT04200911 ↗2
“the autophagy inhibitor: hydroxychloroquine (HCQ) and the autophagy inducer: sirolimus (rapamycin, Rapa) would reduce glucose utilization in sarcoma patients.” PMID 26375670 ↗Oct 2015
“Sirolimus (rapamycin, Rapamune , RAPA) is a novel immunosuppressive agent” NCT00061360 ↗
Known as
rapamun
“Sirolimus (rapamun) is an mTOR inhibitor” NCT05549167 ↗
Known as
Rapamune
“Trial of Continuous Once Daily Oral Treatment Using BIBW 2992 (Afatinib) Plus Sirolimus (Rapamune®) in Patients With Non-small Cell Lung Cancer Harbouring an EGFR Mutation...” NCT00993499 ↗40
“At 1 month, they will have a kidney biopsy and if it is ok, patients will be treated long term with either continued tacrolimus/mycophenolate mofetil or be switched to...” NCT00170053 ↗
“Study to Compare the Safety and Efficacy of Sirolimus (Rapamune) to Tacrolimus (Advagraf) Associated to Mycophenolate Mofetil (CellCept) Between 12 and 36 Months After Kidney...” NCT00811915 ↗
“In detail: Tacrolimus (Prograf or FDA approved generic 0.5 mg, 1 mg or 5 mg capsules, once a day) in combination with Sirolimus (Rapamune, 0.5, 1, and 2mg tablets).” NCT02062892 ↗
“A Post Marketing Surveillance Looking at Safety of Rapamune (Sirolimus) in Indian Population Undergoing de Novo Renal Transplantation.” NCT00195481 ↗
“A Phase I/II, Open-Label Pilot Trial to Evaluate the Safety of Rapamune (Sirolimus) in Patients With Multiple Sclerosis” NCT00095329 ↗
“These newer medications include Prograf (tacrolimus), Cellcept (mycophenolate mofetil), and Rapamune (sirolimus).” NCT00352092 ↗
“A Phase I/II Trial of Sirolimus (Rapamune) and Cyclosporine in Patients With Refractory Aplastic Anemia” NCT00319878 ↗
“Sirolimus (rapamycin, Rapamune , RAPA) is a novel immunosuppressive agent” NCT00061360 ↗
“Sirolimus (Rapamune 2mg/day, Pfizer) or not for a course of 14 days.” NCT01620307 ↗
“Mycophenolate Mofetil; MMF (CellCept) and Sirolimus (Rapamune)” NCT00374647 ↗
“This study will determine the safety and effectiveness of sirolimus (Rapamune® (Registered Trademark)) in treating focal segmental glomerulosclerosis (FSGS), a disease...” NCT00040508 ↗1
“A Phase II Trial of Pemetrexed (Alimta [Registered Trademark]) Combined With Sirolimus (Rapamycin, Rapamune [Registered Trademark]) in Subjects With Relapsed or Refractory NSCLC” NCT00923273 ↗
Known as
rapamycin
“PURPOSE: Pharmacodynamic studies are frequently incorporated into phase I trials, but it is uncommon that they guide dose selection. We conducted a dose selection study with...” PMID 18757332 ↗Sep 200842
“BACKGROUND: Perturbation of the mechanistic target of rapamycin (mTOR) pathway can instruct effector versus memory cell fate of tumor antigen-specific T cells in preclinical...” PMID 40132910 ↗Mar 2025
“The purpose of this study is to determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation compared to Placebo on the signs and symptoms of dry eye in the...” NCT00814944 ↗
“Sirolimus, also known as rapamycin, is a macrolide compound that inhibits its mechanistic target (mTOR), which regulates cell growth and metabolism in response to environmental cues.” NCT05746689 ↗
“A Phase II Trial of Pemetrexed (Alimta [Registered Trademark]) Combined With Sirolimus (Rapamycin, Rapamune [Registered Trademark]) in Subjects With Relapsed or Refractory NSCLC” NCT00923273 ↗
“Sirolimus (INN/USAN), also known as rapamycin, is an immunosuppressant drug used to prevent rejection in organ transplantation; it is especially useful in kidney transplants.” NCT01889992 ↗
“Sirolimus, also known as rapamycin, is a lipophilic macrolide isolated from a strain of Streptomyces hygroscopicus that serves as a strong HbF inducer in vitro and in vivo.” PMID 35755297 ↗Jun 2022
“Sirolimus, also known as rapamycin, is an immunosuppressant that is used to prevent organ transplant rejection by inhibiting mammalian target of rapamycin (mTOR) kinase.” NCT04461340 ↗
“Rapamycin or sirolimus is an anti-inflammatory and immunomodulatory drug that has an enormous potential in ocular surface pathologies such as dry eye disease.” NCT04115800 ↗
“the autophagy inhibitor: hydroxychloroquine (HCQ) and the autophagy inducer: sirolimus (rapamycin, Rapa) would reduce glucose utilization in sarcoma patients.” PMID 26375670 ↗Oct 2015
“We examined the effect of the mTOR inhibitor sirolimus (rapamycin) on renal functional loss and cyst progression in the Han:SPRD rat model of ADPKD.” PMID 16221708 ↗Oct 2005
“an immunotherapy called SEL-110, a nano-encapsulated form of sirolimus.” NCT05778877 ↗
Known as
SIR
“Because sirolimus (SIR) monotherapy was successful in kidney transplantation under antithymocyte globulin (ATG), we undertook a pilot study comparing SIR monotherapy with...” PMID 18212631 ↗Jan 20083
“Sirolimus (SIR) will be administered and dosed according to Moffitt Cancer Center, Department of Blood and Marrow Transplantation standard practice.” NCT02891603 ↗
“comparing sirolimus (SIR) with azathioprine (AZA) in a tacrolimus-based immunosuppressive regimen in lung transplantation.” PMID 20833822 ↗Sep 2010
“rapamycin (mTOR) inhibitor sirolimus (SIR) is an immunosuppressant” PMID 25899445 ↗Apr 2015
Known as
Siro
“BACKGROUND: In an attempt to reduce chronic calcineurin inhibitor induced allograft nephropathy in first cadaver and human leukocyte antigen non-identical living-donor renal...” PMID 14742990 ↗Jan 2004
“Sirolimus for Injection (Albumin Bound), intravenously, once a week, 28 days per cycle (three weeks-on and one week-off)” NCT05125523 ↗
Known as
Sirolimus+MMF or MPS or AZA+Steroid
ClinicalTrials.gov intervention name — accepted as the source's own labelNCT00452361 ↗
Known as
SRL
“As conversion from calcineurin inhibitor to sirolimus (SRL), a mechanistic target of rapamycin inhibitor (mTOR-I), has been shown to enhance immunoregulatory profiles in liver...” PMID 31721246 ↗Jun 20209
“A large industry sponsored phase III clinical trial has been underway for several years where patients have substituted sirolimus (SRL) for calcineurin inhibitors after liver...” NCT01134952 ↗
“low-immunological-risk, CMV-positive kidney transplant recipients receiving preemptive therapy were randomized to be converted (sirolimus [SRL]) or not (control [CTR])” PMID 37046380 ↗Jul 2023
“This study will evaluate whether conversion from cyclosporine, a calcineurin inhibitor (CI) to sirolimus (SRL) results in improved long-term renal function” NCT00452361 ↗
“Sirolimus (SRL) has a considerable inter- and intra- individual variability in clearance.” PMID 15660173 ↗Jan 2005
“tacrolimus (TAC) with sirolimus (SRL) was associated with worse post-transplant outcomes” PMID 28810721 ↗Aug 2017
“de novo CNI minimization combined with sirolimus (SRL) improves graft survival” PMID 19670189 ↗Jun 2009
“Sirolimus (SRL) has a concentration-related effect on hematopoiesis.” PMID 17565578 ↗Jun 2007
“Sirolimus is a macrolide antibiotic produced by Streptomyces hygroscopic that has demonstrated potent immunosuppressive activity in a number of studies.” NCT01374750 ↗
Route
Oral
“SRL is administered as an oral dose of 3 mg/m2/day.” NCT00005113 ↗
Target
MTOR
“A number of mTORIs are already clinically available (e.g., sirolimus, temsirolimus and everolimus)” PMID 19192962 ↗Feb 2009