Delving into the Latest Updates on Oprelvekin with Synapse

Overview

Basic Info

Drug Type

Interleukins

Synonyms

IL-11 (Pfizer), Interleukin-11 (Pfizer), Oprelvekin (USAN/INN)

+ [6]

Target

IL-11RA

Action

stimulants

Mechanism

IL-11RA stimulants(Interleukin 11 receptor alpha stimulants), Thrombopoiesis stimulants

Therapeutic Areas

Hemic and Lymphatic DiseasesImmune System DiseasesCongenital Disorders+ [3]

Active Indication-

Inactive Indication

Colitis, UlcerativeCrohn DiseaseHemophilia A+ [4]

Originator Organization

Pfizer Inc.

Active Organization-

Inactive Organization

Wyeth ABWyeth Pharmaceuticals LLC

University of Pittsburgh

License Organization-

Drug Highest PhaseWithdrawn

First Approval Date

United States (25 Nov 1997),

Thrombocytopenia

RegulationOrphan Drug (United States)

Login to view timeline

Structure/Sequence

Sequence Code 13648

Source: *****

The purpose of this study is to learn more about what causes insulin resistance. It has been suggested that proper breakdown of fat into energy (oxidation) in the body is important to allow insulin to keep blood sugar in the normal range. The investigators want to know if having one of the fatty acid oxidation disorders could have an influence on insulin action. Fatty acid oxidation disorders are genetic disorders that inhibit one of the enzymes that converts fat into energy. The investigators will study both normal healthy people and people with a long-chain fatty acid oxidation disorder.

Start Date01 Feb 2016

Sponsor / Collaborator

Oregon Health & Science University

NCT02314273

/ CompletedPhase 4IIT

Effect of Treatment Using rhIL-11 in Patients With Thrombocytopenia After Chemotherapy for Childhood Acute Lymphoblastic Leukemia

The goal of this clinical research study is to find out if rhIL-11（Interleukin 11） may increase the platelet count in Childhood patients with acute lymphocytic leukemia (ALL) who develop low platelet counts while receiving standard CAT（cyclophosphamide+Cytosine arabinoside+mercaptopurine，7d） therapy.

Start Date01 Sep 2011

Sponsor / Collaborator

Shanghai Children's Medical Center

[+1]

NCT01317966

/ WithdrawnNot ApplicableIIT

A Multicentre Investigation of Recombinant Human Interleukin-11 (rhIL-11) Combination Low-dose Rituximab in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP)

The purpose of this study is to determine whether Recombinant Human Interleukin-11 (rhIL-11) Combination Low-dose Rituximab prednisone are effective and safe in the management of Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP).

Start Date01 Mar 2011

Sponsor / Collaborator

Shandong University

[+5]

100 Clinical Results associated with Oprelvekin

Login to view more data

100 Translational Medicine associated with Oprelvekin

Login to view more data

100 Patents (Medical) associated with Oprelvekin

Login to view more data

391

Literatures (Medical) associated with Oprelvekin

01 Feb 2025·Cancer Treatment Reviews

Managing strategies of chemotherapy and radiotherapy-induced oral mucositis

Review

Author: Wu, Yuqi ; Qiu, Yan ; Shi, Wenjin ; Luo, Xiaobo ; Chen, Qianming ; Li, Chunyu ; Jiang, Yuchen ; Liu, Xiangfei

Radiotherapy and chemotherapy are widely employed as primary non-surgical cancer treatments; however, their non-selective cytotoxicity often leads to adverse events such as oral mucositis (OM), particularly in head and neck cancer therapies. International guidelines provide recommendations for managing chemoradiotherapy-induced OM in various clinical contexts. Subsequently, emerging researches have introduced evidence supporting novel approaches or existing regimens for OM prevention and treatment. The repurposing of established drugs has garnered significant interest due to its shorter development timeline, improved safety profiles, and lower costs compared to new drug development. For example, clinical trials assessing established drugs such as melatonin, clonidine, and pentoxifylline indicate promising potential for managing OM. Additionally, several emerging pharmacological interventions have demonstrated considerable efficacy; SAMITAL and rhIL-11 are supported by phase II clinical trials and prospective studies, while probiotics like Streptococcus salivarius K12 and curcumin have shown effectiveness in randomized clinical trials. Furthermore, recent high-level studies have reinforced the efficacy of non-pharmacological interventions, such as photobiomodulation (PBM) and cryotherapy, over the past two years. In all, given the evidence supporting different strategies, PBM and oral cryotherapy are highly recommended for managing OM when feasible. Topical clonidine, melatonin, oral pentoxifylline, topical SAMITAL or rhIL-11, oral SsK12, and curcumin may also be utilized but would benefit from validation in larger trials. Besides, Verbascoside, Palifermin, Amifostine, and Avasopasem manganese can be suggested for OM management, while the side effects should be monitored. The accessibility and cost/effectiveness of specific managing strategies of OM should be considered when selecting appropriate options.

31 Dec 2024·Radiation Research

Pharmacokinetic and Metabolomic Studies with BBT-059 in Nonhuman Primates Exposed to Total-Body Gamma Radiation

Article

Author: Carlson, Sharon J ; Wise, Stephen Y ; Cheema, Amrita K ; Carpenter, Alana D ; Singh, Vijay K ; Fatanmi, Oluseyi O ; Cox, George N ; Li, Yaoxiang ; Fam, Christine M ; Petrus, Sarah A ; Miranda, Issa Melendez

BBT-059 is a long-acting PEGylated interleukin-11 analog that has been shown to have hematopoiesis-promoting and anti-apoptotic attributes, and is being studied as a radiation countermeasure for the hematopoietic acute radiation syndrome (H-ARS). This potential countermeasure has been demonstrated to enhance survival in irradiated mice. To investigate the toxicity and safety profile of this agent, 14 nonhuman primates (NHPs, rhesus macaques) were administered two different doses of BBT-059 subcutaneously 24 h after 4 Gy total-body irradiation and were monitored for the next 60 days postirradiation. Blood samples were investigated for the pharmacokinetics and pharmacodynamics of this agent and its effects on complete blood counts, cytokines, vital signs, and for metabolomic studies. No adverse effects were observed in either treatment group. Radiation-induced metabolomic dysregulation was observed in both treatment groups, and BBT-059 afforded some short-term radiomitigation. A few pathways were commonly dysregulated by radiation exposure including the steroid hormone biosynthesis pathway, fatty acid activation, and glycerophospholipid metabolism. Notably, radiation-induced dysregulation to the linoleate metabolism pathway was significantly mitigated by either dose of BBT-059. In brief, this study suggests that BBT-059 has a good safety profile in irradiated NHPs and that its development as a medical countermeasure for U.S. Food and Drug Administration approval for human use should be continued.

31 Dec 2024·Cardiovascular Research

Interleukin 11 therapy causes acute left ventricular dysfunction

Article

Author: Hübner, Norbert ; Andrew, Ivan ; Vanezis, Konstantinos ; O’Fee, Katie ; Widjaja, Anissa A ; Barton, Paul J R ; Lee, Michael ; Rahman, Ekhlas ; Sweeney, Mark ; Maatz, Henrike ; Jennings, Emma R ; Tam, Chung Nga ; Cook, Stuart A ; Ramachandra, Chrishan J ; Lindberg, Eric L ; Lim, Wei-Wen ; Hausenloy, Derek J ; Pascual-Navarro, Eneko ; Carling, David ; Villanueva-Hayes, Chelsie

AbstractAimsInterleukin 11 (IL11) was initially thought important for platelet production, which led to recombinant IL11 being developed as a drug to treat thrombocytopenia. IL11 was later found to be redundant for haematopoiesis, and its use in patients is associated with unexplained and severe cardiac side effects. Here, we aim to identify, for the first time, direct cardiomyocyte toxicities associated with IL11, which was previously believed cardioprotective.Methods and resultsWe injected recombinant mouse lL11 (rmIL11) into mice and studied its molecular effects in the heart using immunoblotting, qRT-PCR, bulk RNA-seq, single nuclei RNA-seq (snRNA-seq), and assay for transposase-accessible chromatin with sequencing (ATAC-seq). The physiological impact of IL11 was assessed by echocardiography in vivo and using cardiomyocyte contractility assays in vitro. To determine the activity of IL11 specifically in cardiomyocytes, we made two cardiomyocyte-specific Il11ra1 knockout (CMKO) mouse models using either AAV9-mediated and Tnnt2-restricted (vCMKO) or Myh6 (m6CMKO) Cre expression and an Il11ra1 floxed mouse strain. In pharmacologic studies, we studied the effects of JAK/STAT inhibition on rmIL11-induced cardiac toxicities. Injection of rmIL11 caused acute and dose-dependent impairment of left ventricular ejection fraction (saline: 62.4% ± 1.9; rmIL11: 32.6% ± 2.9, P < 0.001, n = 5). Following rmIL11 injection, myocardial STAT3 and JNK phosphorylation were increased and bulk RNA-seq revealed up-regulation of pro-inflammatory pathways (TNFα, NFκB, and JAK/STAT) and perturbed calcium handling. snRNA-seq showed rmIL11-induced expression of stress factors (Ankrd1, Ankrd23, Xirp2), activator protein-1 (AP-1) transcription factor genes, and Nppb in the cardiomyocyte compartment. Following rmIL11 injection, ATAC-seq identified the Ankrd1 and Nppb genes and loci enriched for stress-responsive, AP-1 transcription factor binding sites. Cardiomyocyte-specific effects were examined in vCMKO and m6CMKO mice, which were both protected from rmIL11-induced left ventricular impairment and molecular pathobiologies. In mechanistic studies, inhibition of JAK/STAT signalling with either ruxolitinib or tofacitinib prevented rmIL11-induced cardiac dysfunction.ConclusionsInjection of IL11 directly activates IL11RA/JAK/STAT3 in cardiomyocytes to cause acute heart failure. Our data overturn the earlier assumption that IL11 is cardioprotective and explain the serious cardiac side effects associated with IL11 therapy.

100 Deals associated with Oprelvekin

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
D05266	Oprelvekin	L03AC02	DB00038

R&D Status

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hemophilia A	Phase 1	United States	University of Pittsburgh	01 Jan 2010
Von Willebrand Diseases	Phase 1	United States	University of Pittsburgh	01 Jan 2010
Menorrhagia	Phase 1	United States	Wyeth AB	01 Jan 2008
Crohn Disease	Phase 1	United States	Wyeth AB	01 Apr 2002
Von Willebrand Disease, Type 1	Preclinical	United States	Wyeth AB	01 Jul 2004
Colitis, Ulcerative	Preclinical	-	Wyeth AB	07 Jun 2002

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02517307 (CTgov)	Not Applicable	Trifunctional Protein Deficiency With Myopathy and Neuropathy \| Medium Chain Acyl CoA Dehydrogenase Deficiency \| Carnitine Palmitoyltransferase II Deficiency, Late-Onset \| Fatty acid oxidation disorder \| VLCAD Deficiency	41	Hyperinsulinemic euglycemic clamp+Glycerol/Saline (Glycerol/Saline FAOD)	huftvcmaxf(aulofustur) = fxneaexlsq zansuybptp (smwohqhyrz, cezmbrrdlr - khosqnxveh) View more	-	30 Jan 2024
				Hyperinsulinemic euglycemic clamp+Heparin+Intralipid (Intralipid FAOD)	huftvcmaxf(aulofustur) = dkravpwoff zansuybptp (smwohqhyrz, ldtikwgpsx - bvdrgxtbxh) View more
ESMO 12023 \| ESMO 22023 Manual	Not Applicable	Thrombocytopenia	14	Hetrombopag + IL-11	(kdltoqsgsi) = ydfmxuxhec gjlgseoegu (rrwmlmpirv ) View more	Positive	21 Oct 2023
				Hetrombopag	(kdltoqsgsi) = mjyamgyoux gjlgseoegu (rrwmlmpirv ) View more
NCT00886743 (CTgov)	Phase 2	Thrombocytopenia	19	Oprelvekin	ywqsioipoy(wyipbmvohl) = bnouomtxrv eazjvfxzth (wosaoqbhek, qycygojors - swdsvywxlb) View more	-	19 Apr 2017
NCT00994929 (IL-11DDAVP, CTgov)	Phase 2	Von Willebrand Diseases \| Hemophilia A	9	Neumega (Oprelvekin, Interleukin 11, IL-11)	gczdpptzzt(svpdlmovip) = bmkjfkpvys ftpocddoaq (qbwcfizxqt, uuwhnzwiiu - vysszozrti) View more	-	02 Mar 2016
NCT00524225 (CTgov)	Phase 2	Von Willebrand Disease, Type 1	3	Neumega (Oprelvekin, Interleukin 11, IL-11)	azewlclqxn(onbxikqitx) = lyrytymudd rocaaxelvi (ylolfqrwyt, jrrmlxdczo - vmmzjuoenw) View more	-	07 Nov 2014
ASCO2010	Phase 2	Thrombocytopenia	83	mIL-11	qybcoitfuo(jpqunlnyqe) = yffcjxqgcy idqgyncpjk (lzblgxrjve )	-	20 May 2010
				rhIL-11	qybcoitfuo(jpqunlnyqe) = sbaplokwbs idqgyncpjk (lzblgxrjve )
ASCO2004	Not Applicable	Relapsed Solid Neoplasm	-	rhTPO	(cjpsgvviqf) = gocrflbfid gztsmmpmiq (zccvfjcjzv ) View more	-	15 Jul 2004
				rhIL-11 + G-SCF	(cjpsgvviqf) = difjielvgx gztsmmpmiq (zccvfjcjzv ) View more

Login to view more data

Translational Medicine

Boost your research with our translational medicine data.

login

or

view full example data

Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.

login

or

view full example data

Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.

login

or

view full example data

Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.

login

or

view full example data

Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.

login

or

view full example data

Accelerate your research with the latest regulatory approval information.

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

login

or

view full example data

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

Understand key drug designations in just a few clicks with Synapse.

login

or

view full example data

Understand key drug designations in just a few clicks with Synapse.

Oprelvekin

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation