主要研究目的：以持证商：Mitsubishi Tanabe Pharma Corporation，ニプロESファーマ株式会社生产的吡嘧司特钾片（规格：10mg，商品名：Alegysal）为参比制剂，以国药集团国瑞药业有限公司生产的吡嘧司特钾片（规格：10mg)为受试制剂，采用随机、开放、单剂量、两周期双交叉设计，评价两种制剂在中国健康受试者中空腹和餐后状态下的生物等效性。次要研究目的：观察健康受试者口服受试制剂吡嘧司特钾片（规格：10mg）和参比制剂吡嘧司特钾片（规格：10mg，商品名：Alegysal）的安全性。

[Translation]

The main purpose of the study is to use the licensed manufacturer Mitsubishi Tanabe Pharma Corporation, Nipro ES Pharmaceutical Co., Ltd.'s pemirolast potassium tablets (specification: 10 mg, trade name: Alegysal) as the reference preparation and the pemirolast potassium tablets (specification: 10 mg) produced by Sinopharm Guorui Pharmaceutical Co., Ltd. as the test preparation. A randomized, open, single-dose, two-period double crossover design was used to evaluate the bioequivalence of the two preparations in fasting and postprandial states in healthy Chinese subjects. Secondary purpose of the study: To observe the safety of oral administration of the test preparation pemirolast potassium tablets (specification: 10 mg) and the reference preparation pemirolast potassium tablets (specification: 10 mg, trade name: Alegysal) in healthy subjects.

Start Date08 Jul 2022

Sponsor / Collaborator

China National Medicines Guorui Pharmaceutical Co., Ltd.

CTR20220169 / CompletedNot Applicable

吡嘧司特钾片人体生物等效性预试验

[Translation] Preliminary study on bioequivalence of Pemirolast Potassium Tablets in human subjects

主要研究目的：按有关生物等效性试验的规定，选择持证商：Mitsubishi Tanabe Pharma Corporation，ニプロESファーマ株式会社生产的吡嘧司特钾片（规格：10mg，商品名：Alegysal）为参比制剂，对国药集团国瑞药业有限公司生产的受试制剂吡嘧司特钾片（规格：10mg）进行空腹和餐后给药人体生物等效性试验，比较受试制剂和参比制剂中药物的吸收速度和吸收程度，考察关键药动学参数的个体内变异度，为正式试验样本量确定及试验方案优化提供依据。次要研究目的：观察健康受试者口服受试制剂吡嘧司特钾片（规格：10mg）和参比制剂吡嘧司特钾片（规格：10mg，商品名：Alegysal）的安全性。

[Translation]

Main purpose of study: According to the relevant provisions of bioequivalence test, the license holder: Mitsubishi Tanabe Pharma Corporation, Nipro ES Pharmaceutical Co., Ltd. produced pemirolast potassium tablets (specification: 10 mg, trade name: Alegysal) as the reference preparation, and the test preparation pemirolast potassium tablets (specification: 10 mg) produced by Sinopharm Group Guorui Pharmaceutical Co., Ltd. were selected as the reference preparation for fasting and postprandial human bioequivalence tests, to compare the absorption rate and degree of the drug in the test preparation and the reference preparation, and to investigate the intra-individual variability of key pharmacokinetic parameters, so as to provide a basis for the determination of the sample size of the formal test and the optimization of the test plan. Secondary purpose of study: To observe the safety of oral administration of the test preparation pemirolast potassium tablets (specification: 10 mg) and the reference preparation pemirolast potassium tablets (specification: 10 mg, trade name: Alegysal) in healthy subjects.

Start Date17 Feb 2022

Sponsor / Collaborator

China National Medicines Guorui Pharmaceutical Co., Ltd.

100 Clinical Results associated with Pemirolast Potassium

100 Translational Medicine associated with Pemirolast Potassium

100 Patents (Medical) associated with Pemirolast Potassium

Literatures (Medical) associated with Pemirolast Potassium

01 Feb 2024·Lung cancer (Amsterdam, Netherlands)

Real-World comprehensive genomic profiling data for diagnostic clarity in pulmonary Large-Cell neuroendocrine carcinoma

Article

Author: Raskina, Kira ; Tapan, Umit ; Tukachinsky, Hanna ; Kulke, Matthew H ; Schrock, Alexa B ; Huang, Richard S P ; Sands, Jacob ; Burns, Laura ; Oxnard, Geoffrey R

BACKGROUND:

Pulmonary large-cell neuroendocrine carcinoma (LCNEC) is an uncommon subtype of lung cancer believed to represent a spectrum of tumors sharing characteristics of both small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). Other groups have proposed genomic LCNEC subtypes, including small cell-like, non-small cell-like, and carcinoid-like subtypes. The primary goal of this study was to better define the NSCLC-like subtype with comprehensive genomic profiling (CGP).

METHODS:

An institutional database was queried to identify tissue specimens (TBx, N = 1,426) and liquid biopsies (LBx, N = 39) submitted for CGP during routine clinical care (8/2014 - 7/2023) with a disease ontology of LCNEC. TBx were profiled with FoundationOne® (F1) or F1CDx, using hybrid-capture technology to detect genomic alterations (GAs).

RESULTS:

1,426 LCNEC samples were genomically profiled. The presence of RB1 and TP53 genomic alterations (GAs) were used to define a SCLC-like subtype (n = 557). A carcinoid-like group was defined by the presence of MEN1 mutation in the absence of TP53 GAs (n = 25). The remaining 844 samples were compared to the SCLC-like group and GAs enriched relative to the SCLC-like samples with a false discovery rate (FDR) < 0.0001 were used to define a NSCLC-like group. These NSCLC-like subtype-defining GAs included SMARCA4, KRAS, FGF3/4/19, STK11, CDKN2A/B, MTAP, and CCND1. Under this schema, 530 samples were classified as NSCLC-like and 314 remained unclassified.

CONCLUSIONS:

Large-scale CGP can better characterize biologically distinct molecular subtypes in LCNEC. Further studies to define how these molecular subtypes may help inform treatment decisions in this complex and challenging malignancy are warranted.

01 Dec 2023·The Prostate

Is prostatic adenocarcinoma with cribriform architecture more difficult to detect on prostate MRI?

Article

Author: Belue, Mason J ; Nemirovsky, Daniel R ; Yilmaz, Enis C ; Kenigsberg, Alexander P ; Lin, Yue ; Mendhiratta, Neil ; Pinto, Peter A ; Turkbey, Baris ; Enders, Jacob J ; Blake, Zoë ; Toubaji, Antoun ; Gurram, Sandeep ; Wood, Bradford J ; Rothberg, Michael ; Choyke, Peter L ; Merino, Maria J ; Harmon, Stephanie A

Abstract:

Background:

Cribriform (CBFM) pattern on prostate biopsy has been implicated as a predictor for high‐risk features, potentially leading to adverse outcomes after definitive treatment. This study aims to investigate whether the CBFM pattern containing prostate cancers (PCa) were associated with false negative magnetic resonance imaging (MRI) and determine the association between MRI and histopathological disease burden.

Methods:

Patients who underwent multiparametric magnetic resonance imaging (mpMRI), combined 12‐core transrectal ultrasound (TRUS) guided systematic (SB) and MRI/US fusion‐guided biopsy were retrospectively queried for the presence of CBFM pattern at biopsy. Biopsy cores and lesions were categorized as follows: C0 = benign, C1 = PCa with no CBFM pattern, C2 = PCa with CBFM pattern. Correlation between cancer core length (CCL) and measured MRI lesion dimension were assessed using a modified Pearson correlation test for clustered data. Differences between the biopsy core groups were assessed with the Wilcoxon‐signed rank test with clustering.

Results:

Between 2015 and 2022, a total of 131 consecutive patients with CBFM pattern on prostate biopsy and pre‐biopsy mpMRI were included. Clinical feature analysis included 1572 systematic biopsy cores (1149 C0, 272 C1, 151 C2) and 736 MRI‐targeted biopsy cores (253 C0, 272 C1, 211 C2). Of the 131 patients with confirmed CBFM pathology, targeted biopsy (TBx) alone identified CBFM in 76.3% (100/131) of patients and detected PCa in 97.7% (128/131) patients. SBx biopsy alone detected CBFM in 61.1% (80/131) of patients and PCa in 90.8% (119/131) patients. TBx and SBx had equivalent detection in patients with smaller prostates (p = 0.045). For both PCa lesion groups there was a positive and significant correlation between maximum MRI lesion dimension and CCL (C1 lesions: p < 0.01, C2 lesions: p < 0.001). There was a significant difference in CCL between C1 and C2 lesions for T2 scores of 3 and 5 (p ≤ 0.01, p ≤ 0.01, respectively) and PI‐RADS 5 lesions (p ≤ 0.01), with C2 lesions having larger CCL, despite no significant difference in MRI lesion dimension.

Conclusions:

The extent of disease for CBFM‐containing tumors is difficult to capture on mpMRI. When comparing MRI lesions of similar dimensions and PIRADS scores, CBFM‐containing tumors appear to have larger cancer yield on biopsy. Proper staging and planning of therapeutic interventions is reliant on accurate mpMRI estimation. Special considerations should be taken for patients with CBFM pattern on prostate biopsy.

01 Dec 2023·Prostate international

Detection of anterior prostate cancer using a magnetic resonance imaging-transrectal ultrasound fusion biopsy in cases with initial biopsy and history of systematic biopsies

Article

Author: Abe, Masakazu ; Maekawa, Shigekatsu ; Sekiguchi, Kie ; Ikarashi, Daiki ; Kato, Renpei ; Kanehira, Mitsugu ; Ujiie, Takashi ; Takata, Ryo ; Obara, Wataru ; Tamura, Daichi

Background:

Prostate cancer in the anterior region may be missed on a transrectal systematic biopsy (SBx). Therefore, this study aimed to evaluate the performance of magnetic resonance imaging-transrectal ultrasound (MRI-TRUS) fusion targeted biopsy (TBx) in detecting anterior region cancer in patients with a history of SBxs.

Methods:

Prostate biopsies were performed in 224 patients after multiparametric MRI, among whom 119 patients with prostate imaging reporting and data system (PI-RADS version 2) scores of 3 to 5 underwent MRI-TRUS fusion TBxs. Afterward, cancer detection rates (CDRs) and TBx-positive core regions were compared by categorizing patients into those with or without a history of SBxs.

Results:

Total CDR was 68.8% (44/64 cases) in the initial biopsy group (Initial-Bx group) and 47.3% (26/55 cases) in the previous-negative-systematic biopsy group (Pre-Neg-SBx group) (P = 0.018). Interestingly, both TBx- and SBx-core positive cases were more common in the Initial-Bx group than in the Pre-Neg-SBx group (Initial-Bx group: 75% [33/44 cases] vs. Pre-Neg-SBx group: 42.3% [11/26 cases], P = 0.006). However, only TBx-core positive cases were more common in the Pre-Neg-SBx group than in the Initial-Bx group (Initial-Bx group: 11.4% [5/44 cases] vs. Pre-Neg-SBx group: 30.8% [8/26 cases], P = 0.043). In addition, the proportion of anterior lesions detected by TBx cores was higher in the Pre-Neg-SBx group than in the Initial-Bx group (Initial-Bx group: 26.3% [10/38 cases] vs. Pre-Neg-SBx group: 52.6% [10/19 cases], P = 0.049).

Conclusion:

Using MRI-TRUS fusion TBx in the evaluation of previously negative SBx cases improved the detection rate of anterior lesions, which might have been missed in previous SBxs. Especially in patients with a history of SBxs mpMRI should be performed to screen for anterior lesions.

News (Medical) associated with Pemirolast Potassium

19 Jul 2023

·www.biospace.com

Redwood Scientific Technologies Inc., Announces Partnership Agreement with Silk Road Ent., Inc., for Retail Distribution of TBX FREE and TBX VAPE FREE

NEW YORK, July 19, 2023 /PRNewswire/ -- Redwood Scientific Technologies Inc. (RSCI. OTC. PK) announces a partnership with Silk Road Ent., Inc. (SKRJ, OTC, PK) for retail distribution of TBX FREE and TBX VAPE FREE, its smoking cessation products. Redwood will bring these nicotine-free solutions to the market to combat addiction to smoking and vaping. The partnership aims to leverage Silk Road's distribution network to reach pharmacies, grocery stores, and convenience stores in the US market. The finalized study for product efficacy and safety is expected to conclude by the end of 2023 before retail distribution begins. Redwood Scientific Technologies Inc. announces a partnership with Silk Road Ent., Inc. for retail distribution For media inquiries, please contact: Public Relations Info@redwoodsci.co 646-503-7884 Company Codes: OTC-BB:RSCI, OTC-BB:SKRJ, OTC-PINK:RSCI, OTC-PINK:SKRJ, OtherOTC:RSCI

100 Deals associated with Pemirolast Potassium

External Link

KEGG	Wiki	ATC	Drug Bank
D01088	Pemirolast Potassium	R	DB00885

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Rhinitis, Allergic, Seasonal	JP	Santen Pharmaceutical Co., Ltd.	20 Jan 1995
Asthma	JP	Alfresa Pharma Corp.	18 Jan 1981
Conjunctivitis, Allergic	JP	Santen Pharmaceutical Co., Ltd.	18 Jan 1981
Rhinitis, Allergic	JP	Alfresa Pharma Corp.	18 Jan 1981

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ARVO2003	Not Applicable	Seasonal allergic conjunctivitis	169	0.1% Pemirolast Potassium Ophthalmic Solution BID	jtinxtpovo(hudnjrwvek) = hbigetbgsk hgijtrkkxt (wlytsiivwb ) View more	Positive	01 May 2003
				0.1% Pemirolast Potassium Ophthalmic Solution QID	jtinxtpovo(hudnjrwvek) = abqrwunpba hgijtrkkxt (wlytsiivwb ) View more

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