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

Action

inhibitors

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-

License Organization-

Drug Highest PhaseApproved

First Approval Date

Japan (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)

BACKGROUNDT2-fluid-attenuated inversion recovery (FLAIR) mismatch sign is a specific imaging finding of isocitrate dehydrogenase (IDH)-mutant astrocytomas. Histologically, a hypointense area on FLAIR images indicates the presence of microcysts. Here we report a case of IDH-mutant astrocytoma that shrunk spontaneously.CASE DESCRIPTIONA 26-year-old woman presented with a complaint of headache. Her magnetic resonance (MR) images revealed a lesion mass with a T2-FLAIR mismatch sign in the left frontal lobe. Subsequently, after 1 month, she was referred to our department, and we found that the lesion had unexpectedly shrunk; however, no further shrinkage was observed in the next 3 months. Furthermore, a biopsy was performed, and the results indicated a diagnosis of astrocytoma, IDH-mutant CNS WHO grade 3. Thus, she underwent subtotal resection. We found no neurological deficits in the patient, and she received 60 Gy of radiotherapy at the local site and chemotherapy with nimustine hydrochloride (ACNU), followed by the administration of ACNU every 8 weeks for 2 years. Overall, after 36 months of tumour resection, she was in good health and exhibited no recurrence. Notably, her histological and MR image findings suggested that the macroscopic cyst was formed by the fusion of microcysts, which is a characteristic feature of IDH-mutant astrocytoma with a T2-FLAIR mismatch sign, and that the tumour shrunk because of the rupture of the cyst in the Sylvian cistern.CONCLUSIONThe present case report suggests that IDH-mutant astrocytoma cannot be ruled out even when the lesion shrinks spontaneously.

01 Jan 2025·Therapeutic Innovation & Regulatory Science

Expanding Pharmaceutical Access Via Over the Counter Drugs

Article

Author: Jouaneh, Terra Marie M. ; Gowda, Vrushab ; Miller, Brian J ; Jouaneh, Terra Marie M ; Miller, Brian J.

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.

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	China	Daiichi Sankyo Co., Ltd.	25 Jul 2002
Philadelphia chromosome positive chronic myelogenous leukemia	China	Daiichi Sankyo Co., Ltd.	25 Jul 2002
Brain Cancer	Japan	Alfresa Pharma Corp.	22 May 1979
Chronic leukemia	Japan	Alfresa Pharma Corp.	22 May 1979
Colorectal Cancer	Japan	Alfresa Pharma Corp.	22 May 1979
Liver Cancer	Japan	Alfresa Pharma Corp.	22 May 1979
Lung Cancer	Japan	Alfresa Pharma Corp.	22 May 1979
Lymphoma	Japan	Alfresa Pharma Corp.	22 May 1979
Stomach Cancer	Japan	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)	(tjipqwvrzm) = wsdezmziql saosogejaa (pyprkvlyrq ) View more	Positive	02 Jun 2022
SNO2018	Phase 1/2	Glioma	49	Temozolomide plus Nimustine	ruadfqjvbr(oexloozyie) = Thirty-five percent of patients experienced grade 3 or 4 toxicities, mainly hematologic ybzjltqywm (ikqkwnkanu )	Positive	05 Nov 2018
SNO2017	Phase 1/2	Glioma	49	Temozolomide plus Nimustine	wppraefbxd(izvfkvfiiq) = Thirty-five percent of patients experienced grade 3 or 4 toxicities, mainly hematologic metrjhrugj (fbzugpwunp ) View more	Positive	06 Nov 2017
SNO2016	Phase 1/2	Glioma	7	ACNU 0.25 mg/mL	glswwuehyf(gopucnoyaz) = One in 3 patients who received 0.5 mg/mL developed lacunar infarction qdnqgnlssb (ssthvuxmop )	Positive	07 Nov 2016
SNO2016	Phase 1/2	Glioma	7	ACNU 0.5 mg/mL		Positive	07 Nov 2016
SNO2016	Phase 1/2	Glioma	49	Temozolomide plus Nimustine	euzgcfhuyz(jyqcoglgtg) = Thirty-five percent of patients (14 of 40) experienced grade 3 or 4 toxicities, mainly hematologic rhkwmzsbii (fhcgtchtcl )	Positive	07 Nov 2016
ASCO2010	Not Applicable	Glioma	359	ACNU alone or ACNU plus other chemotherapeutic drugs	oiztnerrje(vfrlcijvty) = qgxytvgive poqmanrkac (tvmwlgumzk )	-	20 May 2010
ASCO2010	Not Applicable	Glioma	359	TMZ alone or TMZ plus other chemotherapeutic drugs	krstivekec(luwcsotjqo) = ntnemvgjvt buzkwbqxxi (zffhtmjzzl )	-	20 May 2010
NOA-01 (ASCO2008)	Not Applicable	Recurrent Glioblastoma Third line	35	Nimustine plus teniposide	qvofcoprgz(snekcybewa) = mrxbywklyw rkrnagriji (dyoooplcws ) View more	Positive	20 May 2008
ASCO2008	Not Applicable	Glioblastoma	151	ACNU-CDDP	(amgikgpobu) = ltwnlktjbb zzvnouhstm (oxprlioruq )	Positive	20 May 2008