Delving into the Latest Updates on Nimustine Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Nimustine, Nimustine hydrochloride (JAN), 尼莫司汀

+ [6]

Target

DNA

Mechanism

DNA inhibitors(DNA inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesNervous System Diseases+ [3]

Active Indication

Chronic Lymphocytic LeukemiaPhiladelphia chromosome positive chronic myelogenous leukemiaBrain Cancer+ [6]

Inactive Indication-

Originator Organization

Daiichi Sankyo Co., Ltd.

Active Organization

Daiichi Sankyo Co., Ltd.

Alfresa Pharma Corp.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

JP (22 May 1979),

Brain CancerChronic leukemiaColorectal Cancer+ [4]

Regulation-

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Structure/Sequence

Molecular FormulaC9H13ClN6O2

InChIKeyVFEDRRNHLBGPNN-UHFFFAOYSA-N

CAS Registry42471-28-3

View All Structures (2)

AbstractThis commentary addresses the recent U.S. Food & Drug Administration (FDA) proposed rule to expand access to nonprescription drugs through additional conditions of nonprescription use (ACNU). It surveys the various pathways to market for pharmaceutical products, noting the distinct requirements for over-the-counter (OTC) products differentiating them from prescription products. It subsequently reviews the ACNU proposed rule, weighing its potential benefits against possible limitations. With a view towards the future, the ACNU proposed rule is acknowledged as part of a longstanding tradition to expand drug channels in a risk-stratified fashion with increasing clinical oversight to address in tandem increasing consumer risks. Finally, the proposed rule also serves as a potential prelude for a future behind the counter drug pathway.

01 Dec 2024·Pharmacoepidemiology and Drug Safety

Core Concepts in Pharmacoepidemiology: New‐User Designs

Review

Author: Young, Jessica C. ; Webster‐Clark, Michael ; Rouette, Julie ; Her, Qoua L. ; Tazare, John

ABSTRACTIn this article, we review the history and key reasons for new‐user comparisons in pharmacoepidemiology, highlighting the target trial framework as a unifying framework. We describe three distinct pharmacoepidemiological new‐user study designs: (1) new‐user versus non‐user; (2) active comparator new‐user; (i.e., ACNU) and (3) prevalent new‐user (i.e., PNU) designs, and discuss how each relates to key issues of defining time zero, choosing appropriate comparator groups, and potential sources of bias they do and do not account for. We use a clinical example of hormone replacement therapy and the risk of coronary heart disease to illustrate practical considerations surrounding the application of the three designs presented.

01 Sep 2024·Veterinary Medicine and Science

A case report of feline mast cell tumour with intertumoral heterogeneity: Identification of secondary mutations c.998G>C and c.2383G>C in KIT after resistance to toceranib

Article

Author: Tani, Hiroyuki ; Ito, Keita ; Miyoshi, Noriaki ; Nakayama, Tomohiro ; Fujiki, Makoto ; Hifumi, Tatsuro ; Kuramoto, Tomohide

AbstractA 12‐year‐old male domestic cat with multiple subcutaneous mast cell tumours (MCTs) presented with a 2‐week history of pruritus and raw/bleeding skin from self‐trauma at Kagoshima University Veterinary Teaching Hospital. Polymerase chain reaction (PCR) and histopathological analyses revealed intertumoral heterogeneity among tumour locations based on the mutation status of KIT. In addition, the expression pattern of KIT was characterized. After failed treatment with vinblastine (2.0–2.2 mg/m2, intravenous administration, two doses in total) or nimustine (25 mg/m2, intravenous administration, two doses in total), toceranib (2.2–2.6 mg/kg, orally administered, every other day) was administered to treat recurrent MCTs harbouring the KIT exon eight internal tandem duplication mutation, achieving a complete response. However, toceranib resistance developed 2 months after treatment initiation. Subsequent PCR analysis was conducted to identify the mutational status of KIT in each MCT and to detect the presence of secondary mutations associated with the acquisition of toceranib resistance. Secondary KIT mutations (c.998G>C and c.2383G>C), which were not initially detected in tumour cells at diagnosis, were identified after the development of resistance to toceranib. This indicates that the tumour cells in feline MCTs in the same case have diverse characteristics. Our findings encourage further investigation into the development of therapeutic strategies for feline MCTs, particularly focusing on the heterogeneous nature of KIT/KIT and overcoming acquired resistance to toceranib.

100 Deals associated with Nimustine Hydrochloride

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External Link

KEGG	Wiki	ATC	Drug Bank
D01059	Nimustine Hydrochloride	L01AD06	DB13069

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Chronic Lymphocytic Leukemia	CN	Daiichi Sankyo Co., Ltd.	25 Jul 2002
Philadelphia chromosome positive chronic myelogenous leukemia	CN	Daiichi Sankyo Co., Ltd.	25 Jul 2002
Brain Cancer	JP	Alfresa Pharma Corp.	22 May 1979
Chronic leukemia	JP	Alfresa Pharma Corp.	22 May 1979
Colorectal Cancer	JP	Alfresa Pharma Corp.	22 May 1979
Liver Cancer	JP	Alfresa Pharma Corp.	22 May 1979
Lung Cancer	JP	Alfresa Pharma Corp.	22 May 1979
Lymphoma	JP	Alfresa Pharma Corp.	22 May 1979
Stomach Cancer	JP	Alfresa Pharma Corp.	22 May 1979

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


JPRN-jRCT2021190003 (ASCO2022)	Phase 2	Diffuse Intrinsic Pontine Glioma	21	CED of nimustine hydrochloride (ACNU)	(pmljaxwohp) = uuijaybubm htaureyhai (nhhkdujpgl ) View more	Positive	02 Jun 2022
SNO2018	Phase 1/2	Glioma	49	Temozolomide plus Nimustine	lrwauohoul(kpuiyggdgc) = Thirty-five percent of patients experienced grade 3 or 4 toxicities, mainly hematologic iqrisgsfdv (awveqvgtoc )	Positive	05 Nov 2018
SNO2017	Phase 1/2	Glioma	49	Temozolomide plus Nimustine	aewnlkggas(wyqyjprqnl) = Thirty-five percent of patients experienced grade 3 or 4 toxicities, mainly hematologic bhmvfkuzno (tuyoackssh ) View more	Positive	06 Nov 2017
SNO2016	Phase 1/2	Glioma	49	Temozolomide plus Nimustine	aulffspfqd(koxxdhfgwt) = Thirty-five percent of patients (14 of 40) experienced grade 3 or 4 toxicities, mainly hematologic osgtegwnhu (hjxcgoiwri )	Positive	07 Nov 2016
ASCO2010	Not Applicable	Glioma	359	ACNU alone or ACNU plus other chemotherapeutic drugs	glomakswfl(noqfvogdzz) = kxocupudsh uibtkacyhf (pcxghcodtc )	-	20 May 2010
ASCO2010	Not Applicable	Glioma	359	TMZ alone or TMZ plus other chemotherapeutic drugs	ugteshestj(vngennhvzi) = txpqofloqu cfadcfrtmu (wbydoswhaf )	-	20 May 2010
NOA-01 (ASCO2008)	Not Applicable	Recurrent Glioblastoma Third line	35	Nimustine plus teniposide	itbzwzywbh(gzwcywmovg) = uoskhlppga xhfwgdoxyt (tbgymljdxd ) View more	Positive	20 May 2008
ASCO2008	Not Applicable	Glioblastoma	151	ACNU-CDDP	(skvkcjegze) = xtokowwthi wevurjxptw (qgdakuperx )	Positive	20 May 2008