Delving into the Latest Updates on Ridaforolimus with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

BioNIR, Deforolimus, EluNIR

+ [8]

Target

mTORC1 x mTORC2

Mechanism

mTORC1 inhibitors(Mammalian target of Rapamycin (mTORC1) inhibitors), mTORC2 inhibitors(mTOR Complex 2 inhibitors)

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal DiseasesOther Diseases+ [6]

Active Indication-

Inactive Indication

Advanced cancerAdvanced Endometrial CarcinomaAdvanced Malignant Solid Neoplasm+ [26]

Originator Organization

ARIAD Pharmaceuticals, Inc.

Active Organization-

Inactive Organization

Merck Sharp & Dohme Corp.

National Cancer Institute

ARIAD Pharmaceuticals, Inc.

+ [2]

Drug Highest PhaseDiscontinuedPhase 3

First Approval Date-

RegulationOrphan Drug (US)

Structure

Molecular FormulaC53H84NO14P

InChIKeyBUROJSBIWGDYCN-UHFFFAOYSA-N

CAS Registry572924-54-0

Device:
EluNIR Ridaforolimus Eluting Coronary Stent System - (hereafter referred to as EluNIR) 2.25 mm diameter (8 mm, 12 mm, 15 mm, 17 mm, 20 mm, 24 mm, 28 mm and 33 mm length)
Objectives:
To further assess the safety and efficacy of the small diameter (2.25 mm) Ridaforolimus Eluting Stent - EluNIR.
Subject Population:
Subjects who underwent PCI for angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), NSTEMI, and recent STEMI (>24 hours from initial presentation and stable) with attempted implantation of a 2.25 mm diameter EluNIR stent.
Trial Design and Methods:
This is a prospective, multi-center, single-arm, open-label clinical trial. Clinical follow-up for all patients will be performed at 30 days 6 months, and 1 year after the procedure.

Start Date31 Dec 2020

Sponsor / Collaborator

Medinol Ltd.

NCT03702608 / CompletedNot Applicable

Prospective, Multi-center, Single-arm, Open-label Clinical Trial, to Further Assess the Safety and Efficacy of Long (38 mm) Ridaforolimus Eluting Stent - EluNIR

This is a prospective, multi-center, single-arm, open-label clinical trial. Clinical follow-up will be performed at 30 days. Follow-up by phone will be performed at 6 months, and 1 year after the procedure. Study Objective is to further assess the safety and efficacy of long (38 mm) Ridaforolimus Eluting Stent - EluNIR.

Start Date14 Nov 2018

Sponsor / Collaborator

Medinol Ltd.

EUCTR2012-000335-11-DE / Not yet recruitingPhase 2

A Phase 2 Randomized Trial of the Combination of Ridaforolimusand Exemestane, Compared to Ridaforolimus, Dalotuzumaband Exemestane in High Proliferation, Estrogen Receptor PositiveBreast Cancer Patients - A phase IIb study of ridaforolimus, dalotzumab and exemestane in combination in advanced breast canc

Start Date30 Oct 2012

Sponsor / Collaborator-

100 Clinical Results associated with Ridaforolimus

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100 Translational Medicine associated with Ridaforolimus

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100 Patents (Medical) associated with Ridaforolimus

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159

Literatures (Medical) associated with Ridaforolimus

16 Jan 2024·Journal of the American Heart Association

Percutaneous Coronary Interventions Using a Ridaforolimus‐Eluting Stent in Patients at High Bleeding Risk

Article

Author: Roguin, Ariel ; Karamasis, Grigoris V ; Witberg, Guy ; Jonas, Michael ; Johnson, Thomas W ; Jadhav, Sachin ; Danenberg, Haim ; Assali, Abid ; Baumbach, Andreas ; Konigstein, Maayan ; Blaxill, Jonathan ; Halabi, Majdi ; Issever, Melek Ozgu ; Hoole, Stephen ; Lev, Eli ; Vaknin-Assa, Hana ; Kerner, Arthur ; Ben-Yehuda, Ori ; Kornowski, Ran ; Segev, Amit ; Anderson, Richard

Background:

Patients treated with percutaneous coronary intervention are often considered to be at a high bleeding risk (HBR). Drug‐eluting stents have been shown to be superior to bare‐metal stents in patients with HBR, even when patients were given abbreviated periods of dual antiplatelet therapy (DAPT). Short DAPT has not been evaluated with the EluNIR ridaforolimus‐eluting stent. The aim of this study was to evaluate the safety and efficacy of a shortened period of DAPT following implantation of the ridaforolimus‐eluting stent in patients with HBR.

Methods and Results:

This was a prospective, multicenter, binational, single‐arm, open‐label trial. Patients were defined as HBR according to the LEADERS‐FREE (Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug‐Coated Stent versus the Gazelle Bare‐Metal Stent in Patients at High Bleeding Risk) trial criteria. After percutaneous coronary intervention, DAPT was given for 1 month to patients presenting with stable angina. In patients presenting with an acute coronary syndrome, DAPT was given for 1 to 3 months, at the investigator's discretion. The primary end point was a composite of cardiac death, myocardial infarction, or stent thrombosis up to 1 year (Academic Research Consortium definite and probable). Three hundred fifteen patients undergoing percutaneous coronary intervention were enrolled, and 56.4% presented with acute coronary syndrome; 33.7% were receiving oral anticoagulation. At 1 year, the primary end point occurred in 15 patients (4.9%), meeting the prespecified performance goal of 14.1% ( P <0.0001). Stent thrombosis (Academic Research Consortium definite and probable) occurred in 2 patients (0.6%). Bleeding Academic Research Consortium type 3 and 5 bleeding occurred in 6 patients (1.9%).

Conclusions:

We observed favorable results in patients with HBR who underwent percutaneous coronary intervention with a ridaforolimus‐eluting stent and received shortened DAPT, including a low rate of ischemic events and low rate of stent thrombosis.

Registration:

URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03877848.

01 Jan 2024·Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions

Percutaneous coronary intervention with ridaforolimus eluting‐stents in small vessel coronary artery disease

Article

Author: Jonas, Michael ; Kerner, Arthur ; Arow, Ziad ; Koifman, Edward ; Gabarin, Mustafa ; Roguin, Ariel ; Pereg, David ; Issever, Melek Ozgu ; Konigstein, Maayan ; Cafri, Carlos ; Witberg, Guy ; Vaknin-Assa, Hana ; Rubinshtein, Ronen ; Segev, Amit ; Assali, Abid

Abstract:

Introduction:

The ridaforolimus‐eluting stent (RES) system uses a novel cobalt alloy‐based coronary stent with a durable elastomeric polymer eluting ridaforolimus.

Aim of study:

To assess the safety and efficacy of small diameter (2.25 mm) RES (EluNIR) in small coronary artery disease.

Methods:

A prospective, multicenter, single‐arm, open‐label clinical trial. Clinical follow‐up was performed at 30 days, 6 months, and 1 year after the procedure. Target lesions were located in native coronary arteries or bypass graft conduits, with visually estimated diameter of ≥2.25 mm to ≤2.5 mm. The primary endpoint was combined device success, defined as final in‐stent residual diameter stenosis <30%, without 30‐day major adverse cardiovascular events (MACE).

Results:

A total of 81 patients were enrolled in the study. Twenty‐three patients (28%) had acute coronary syndrome (ACS) at presentation and 37 (46%) had prior myocardial infarction (MI). Most of the target lesions were located in the circumflex coronary artery (44%) and were classified as B2/C grade according to the American Heart Association/American College of Cardiology classification. The final mean minimal lumen diameter, mean reference vessel diameter, and mean residual percent diameter stenosis were 2.0 ± 0.2 mm, 2.3 ± 0.1 mm, and 14 + 6.6%, respectively. The primary endpoint of device success without 30‐day MACE was achieved in 98.8% of the patients. Target lesion failure (TLF) at 6 months was 1.2%. Thirty‐day and 1‐year MACE rates were 1.2% and 2.5%, respectively.

Conclusion:

The EluNIR 2.25 mm stent shows excellent results in small coronary artery disease and adds another tool in the treatment of this complex lesion type.

01 Sep 2023·Coronary artery disease

Percutaneous coronary intervention with ridaforolimus-eluting stents in long lesions: the BIONICS 38 mm prospective trial.

Article

Author: Ben-Yehuda, Ori ; Assali, Abid ; Jonas, Michael ; Banai, Shmuel ; Chernin, Gil ; Segev, Amit ; Tuvali, Ortal ; Danenberg, Haim ; Haberman, Dan

BACKGROUND:

The ridaforolimus-eluting stent (RES) system is a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting ridaforolimus. The aim of this trial was to assess the performance of a 38 mm RES in long coronary lesions.

METHODS:

A prospective, multicenter, single-arm, open-label clinical trial. Clinical follow-up was performed at 30 days, 6 months, and 1 year after the procedure. Target lesions were located in native coronary arteries or bypass graft conduits, with visually estimated diameters of ≥2.75 mm to ≤4.25 mm. The primary endpoint was combined efficacy (final in-stent residual diameter stenosis <30%) without 30-day major adverse cardiovascular events (MACE) (composite of cardiac death, any myocardial infarction), or ischemia-driven target lesion revascularization.

RESULTS:

A total of 50 patients were enrolled in the study. Fourteen (28%) had acute coronary syndromes; 17 (34%) had diabetes. The mean lesion length was 32.4 mm ± 8.3, reference vessel diameter 2.88 mm ± 0.45, minimal lumen diameter 0.80 mm ± 0.41, and percent diameter stenosis 72.6% ± 13.2. The primary endpoint was achieved in 88% (44/50) of the patients (95% confidence interval: 75.7-95.5%). Thirty-day and 1-year MACE rates were 6% and 8%, respectively. Target lesion failure after 1 year occurred in three patients (6%). Forty-seven lesions (94%) were treated successfully, with final in-stent diameter stenosis of < 30% [95% confidence interval: (84-99%).

CONCLUSION:

Percutaneous coronary intervention (PCI) of long lesions with a 38 mm RES achieved satisfactory results, and support the safety and efficacy of PCI with RES in patients with long lesions. (ClinicalTrials.gov NCT03702608).

4

News (Medical) associated with Ridaforolimus

25 Oct 2023

·www.nsmedicaldevices.com

Medinol secures FDA approval for EluNIR-PERL coronary stent system

EluNIR-PERL, the latest addition to Medinol’s EluNIR family of DES products, has four radiopaque markers, two at each end of the stent, and a radiopaque catheter tip made of hybrid polymer-metal, to facilitate superior visualisation during PCI procedures EluNIR-PERL drug-eluting coronary stent closeup. (Credit: PRNewswire/ CoSo Health) Israeli medical device maker Medinol has received the US Food and Drug Administration (FDA) approval for its EluNIR-PERL drug-eluting stent (DES) system to treat coronary artery disease. EluNIR-PERL is the latest coronary stent in its EluNIR family of DES products and builds on the company’s existing EluNIR DES system. The system comes with four radiopaque markers, two at each end of the stent, and a radiopaque catheter tip made of hybrid polymer-metal. Its unique features facilitate superior visualisation during PCI procedures including navigation through complex anatomies and placement of the stent, said the medical device maker. Medinol CEO Yoram Richter said: “We are pleased to bring technologies to the US that focus both on the benefit to patients as well as unique and meaningful advantages to surgeons, allowing for precise stent placement, shorter procedure times and reduced radiation exposure.” EluNIR-PERL is the company’s seventh-generation stent and features a unique stent design that leverages its unique CoCr framework. The CoCr framework comprises struts with varying widths and integrates radiopaque markers into the structure of the stent system. In addition, the stent also features a specialised radiopaque-enhanced metal spring tip intended for navigating through complex anatomies. The advanced design features would enable physicians with accurate positional information and precise stent placement during PCI procedures, said the medical device company. Medinol intends to commercialise the EluNIR-PERL in the US, exclusively through CoSo Health, a healthcare supply and logistics company that distributes and sells medical devices. Building on its sales rep-light model, advanced cloud-based logistics platform and customised delivery model, CoSo Health is said to reduce waste from the supply chain. CoSo Health CEO Jae Lee said: “We are proud to distribute one of the world’s best drug-eluting stents via our intuitive and easy-to-use SaaS+ platform, which reduces layers in the supply chain.”

Radiation Therapy

24 Oct 2023

·www.prnewswire.com

Medinol Receives FDA Approval for Next Generation EluNIR-PERL™ Drug-Eluting Coronary Stent System

CoSo Health to exclusively distribute Medinol's most advanced coronary DES in the U.S. DENVER and TEL AVIV, Israel, Oct. 24, 2023 /PRNewswire/ -- Medinol today announced United States Food and Drug Administration (FDA) approval for the EluNIR-PERL™ drug-eluting stent (DES) for the treatment of coronary artery disease. Continue Reading EluNIR-PERL™ Drug-Eluting Coronary Stent Closeup EluNIR-PERL builds upon the proven performance and clinical data of the EluNIR™ DES system. As the latest evolution in the EluNIR DES family, EluNIR-PERL features four radiopaque markers, two at each end of the stent, and a hybrid polymer-metal radiopaque catheter tip. These unique features allow outstanding visualization during PCI procedures whether navigating through complex anatomies or precise placement of the stent. "We are pleased to bring technologies to the U.S. that focus both on benefit to patients as well as unique and meaningful advantages to surgeons, allowing for precise stent placement, shorter procedure times and reduced radiation exposure," said Yoram Richter, CEO of Medinol. "We are proud to distribute one of the world's best drug-eluting stents via our intuitive and easy-to-use SaaS+ platform, which reduces layers in the supply chain," said Jae Lee, CEO of CoSo Health. EluNIR-PERL™ is exclusively available in the United States through CoSo Health, an innovative healthcare supply and logistics company changing the way medical devices are distributed and sold. About CoSo Health CoSo Health is redefining the healthcare supply chain with an innovative SaaS+ platform that more efficiently sources, warehouses, and distributes medical supplies and devices, bringing best-in-class products and devices to the market at great value. Visit or contact CoSo Health Chief Executive Officer Jae Lee at [email protected]. About Medinol At Medinol, we are aggressively changing paradigms in how disease states are diagnosed and treated. Whether designing cutting edge devices for stenting multiple areas of the body, dramatically reducing complications in Structural Heart procedures or providing real time insights into the physiological metrics of the human body through implantable sensors, we boldly reassess current technology and procedures and look years into the future to pioneer new devices to broaden the reach of physicians both physically and geographically. For more information, see . SOURCE CoSo Health

Radiation Therapy

31 May 2023

·www.nsmedicaldevices.com

Medinol Partners with CoSo Health to Launch the EluNIR Drug-Eluting Stent in the U.S.

CoSo Health to work with U.S. Endovascular and others to reach the U.S. market The announcement comes at a time when hospitals, payers and outpatient facilities are seeking ways to reduce surgical costs. (Credit: Medinol) CoSo Health today announced signing a U.S. distribution agreement with Medinol for EluNIR, a new generation, thin-strut drug-eluting stent (DES). Medinol is a global leader in the development of innovative implantable medical devices. U.S. Endovascular sells peripheral and coronary devices nationwide. CoSo Health is changing the way medical devices are distributed and sold. Through its sales rep-light model, innovative cloud-based logistics platform and customized delivery model, CoSo Health cuts waste from the supply chain. The announcement comes at a time when hospitals, payers and outpatient facilities are seeking ways to reduce surgical costs. “We are extremely excited to partner with CoSo Health to expand our reach within the U.S.,” said Jeff Roach, Chief Commercial Officer at Medinol. “We are both innovators – Medinol with world-class implantable device technology and CoSo Health with logistics and distribution. Together, we are disrupting the distribution of drug-eluting stents through a direct-to-end user model that brings tremendous economic value to purchasers.” The EluNIR DES offers excellent clinical outcomes and an outstanding safety profile. Its best-in-class metal-to-artery ratio and ultra-durable polymer coating, along with a unique delivery system, combine to provide a new standard in treatment capabilities. Successive generations of EluNIR are coming to the global market soon. Source: Company Press Release

100 Deals associated with Ridaforolimus

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External Link

KEGG	Wiki	ATC	Drug Bank
D08900	Ridaforolimus	L01XE19	DB06233

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic osteosarcoma	Phase 3	-	Merck Sharp & Dohme Corp.	01 Oct 2007
Metastatic Soft Tissue Sarcoma	Phase 3	-	Merck Sharp & Dohme Corp.	01 Oct 2007
Estrogen receptor positive breast cancer	Phase 2	-	Merck Sharp & Dohme Corp.	17 Sep 2010
Advanced cancer	Phase 2	-	Merck Sharp & Dohme Corp.	01 Feb 2009
Castration-Resistant Prostatic Cancer	Phase 2	-	Merck Sharp & Dohme Corp.	01 Oct 2008
Advanced Endometrial Carcinoma	Phase 2	-	Merck Sharp & Dohme Corp.	01 Aug 2008
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 2	-	Merck Sharp & Dohme LLC	01 Jul 2008
Recurrent Endometrial Cancer	Phase 2	-	Merck Sharp & Dohme Corp.	01 Aug 2005
Prostatic Cancer	Phase 2	US	Merck Sharp & Dohme Corp.	01 May 2005
Advanced Sarcoma	Phase 2	-	Merck Sharp & Dohme Corp.	01 Oct 2004

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01169532 (CTgov)	Phase 1	Advanced Malignant Solid Neoplasm \| Lymphoma	16	biopsy+Vorinostat+ridaforolimus	wncshxjccf(gtanukumdt) = jccdrhfijx ipaiyqdcxg (ptzkzsftxy, butmpycdkv - ijsdccqzdw) View more	-	21 Feb 2021
NCT03702608 (CTgov)	Not Applicable	Coronary Stenosis	50	EluNIR Ridaforolimus Eluting Coronary Stent System	ytskrgfgqp(tfmchsodqo) = csyugaqltg nygfrbimqn (mabfeltjxy, fcnqnlynlf - ionznsygtx) View more	-	28 Oct 2020
NCT00874731 (MK-8669-037 \| 8669-037, CTgov)	Phase 1	Advanced cancer	23	placebo (Pt 1, Day 1. Placebo)	kyvdrtozje(hjimdgyrey) = ojmahvnsgy dyyzimnlpy (fgwitpyfid, yyabdxaonf - rrynffovel) View more	-	06 May 2019
				Ridaforolimus (Pt 1, Day 2. Ridaforolimus 100 mg)	kyvdrtozje(hjimdgyrey) = arkpwdajgi dyyzimnlpy (fgwitpyfid, dylxjjlcbh - mchgnfhfwd) View more
NCT01380184 (CTgov)	Phase 1	Advanced cancer	15	ridaforolimus	tnqvsodtht(uileslszwc) = zlpvuporfb kvqurielhx (upfioswmap, ggnsifjccu - ttdkxomnrg) View more	-	19 Apr 2019
NCT01431534 (CTgov)	Phase 1	Advanced Malignant Solid Neoplasm \| FGF19 positive Solid Tumors	20	Ridaforolimus (Ridaforolimus 22 mg/m^2)	lpszqjibnj(mydooqoemg) = gvbhkyevdq kwxfopsllf (abcixqmlcl, goeakxsfom - tblwcftubp) View more	-	01 Mar 2019
				Ridaforolimus (Ridaforolimus 28 mg/m^2)	lpszqjibnj(mydooqoemg) = pyxrxdwwig kwxfopsllf (abcixqmlcl, ojfbwwbcak - cfwsdbtwgo) View more
NCT01243762 (0646-027, CTgov)	Phase 1	Advanced cancer	47	MK-0752+dalotuzumab (Dalotuzumab 7.5 mg/kg + MK-0752 1800 mg)	xkepghsdse(jquzrrocyb) = uwpuznwhqw tjpeohzkwr (tncmmdmmwx, hsxffqfcxa - nbwrafbqag) View more	-	30 Oct 2017
				MK-0752+dalotuzumab (Dalotuzumab 10 mg/kg + MK-0752 1800 mg)	xkepghsdse(jquzrrocyb) = zlgazdelwr tjpeohzkwr (tncmmdmmwx, trtarclzod - bzbnleezci) View more
NCT01995487 (BIONICS Trial, Pubmed)	Not Applicable	Coronary Artery Disease	1,919	Ridaforolimus-eluting stents (RESs)	cpoznhnpnj(wpsqquyndh) = giizjeloym sdwnwxxjzl (zyzdhsqamf ) View more	-	03 Oct 2017
				Slow-release zotarolimus-eluting stents	cpoznhnpnj(wpsqquyndh) = pgnyfrltku sdwnwxxjzl (zyzdhsqamf ) View more
NCT01605396 (8669-064 \| MK-8669-064, Pubmed \| Breast Cancer Res) Manual	Phase 2	Advanced breast cancer	80	dalotuzumab+ridaforolimus+exemestane	cjvzldqove(dztnybuvbc) = oypsqodrho phnzjsblxu (fejuqllktu ) View more	Negative	01 Oct 2017
				dalotuzumab+ridaforolimus	cjvzldqove(dztnybuvbc) = vfuzdlruef phnzjsblxu (fejuqllktu ) View more
NCT01256268 (Pubmed \| BMC Cancer) Manual	Phase 1	Solid tumor	24	paclitaxel+carboplatin+ridaforolimus	biupnjvbsq(budnwwmtiq) = cbnxaqkorj swgyzkkzlf (ibolbjmeym ) View more	Positive	08 Jun 2017
NCT01234857 (8669-041, Pubmed \| Breast Cancer Res)	Phase 2	Estrogen receptor positive breast cancer	115	Ridaforolimus 30 mg + Dalotuzumab 10 mg/kg	hnlhkagray(ftcbwuoiay) = vpdpeymmiz wxhpjrcunt (tkyvyauerc )	Negative	01 Jun 2017
				Exemestane 25 mg	hnlhkagray(ftcbwuoiay) = ajwtfydmed wxhpjrcunt (tkyvyauerc )