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

107

Literatures (Medical) associated with Pemirolast Potassium

01 Oct 2024·BREAST CANCER RESEARCH AND TREATMENT

Comprehensive genomic profiling of ESR1, PIK3CA, AKT1, and PTEN in HR(+)HER2(−) metastatic breast cancer: prevalence along treatment course and predictive value for endocrine therapy resistance in real-world practice

Article

Author: Quintanilha, Julia C F ; Bhave, Manali A ; McArthur, Heather ; Kalinsky, Kevin ; Tukachinsky, Hanna ; Huang, Richard S P ; Graf, Ryon P ; Li, Gerald ; Ross, Jeffrey S ; Levy, Mia A ; Scott, Takara ; Pasquina, Lincoln

Abstract:

Background:

The treatment landscape for HR(+)HER2(−) metastatic breast cancer (MBC) is evolving for patients with ESR1 mutations (mut) and PI3K/AKT pathway genomic alterations (GA). We sought to inform clinical utility for comprehensive genomic profiling (CGP) using tissue (TBx) and liquid biopsies (LBx) in HR(+)HER2(−) MBC.

Methods:

Records from a de-identified breast cancer clinicogenomic database for patients who underwent TBx/LBx testing at Foundation Medicine during routine clinical care at ~ 280 US cancer clinics between 01/2011 and 09/2023 were assessed. GA prevalence [ESR1mut, PIK3CAmut, AKT1mut, PTENmut, and PTEN homozygous copy loss (PTENloss)] were calculated in TBx and LBx [stratified by ctDNA tumor fraction (TF)] during the first three lines of therapy. Real-world progression-free survival (rwPFS) and overall survival (rwOS) were compared between groups by Cox models adjusted for prognostic factors.

Results:

~ 60% of cases harbored 1 + GA in 1st-line TBx (1266/2154) or LBx TF ≥ 1% (80/126) and 26.5% (43/162) in LBx TF < 1%. ESR1mut was found in 8.1% TBx, 17.5% LBx TF ≥ 1%, and 4.9% LBx TF < 1% in 1st line, increasing to 59% in 3rd line (LBx TF ≥ 1%). PTENloss was detected at higher rates in TBx (4.3%) than LBx (1% in TF ≥ 1%). Patients receiving 1st-line aromatase inhibitor + CDK4/6 inhibitor (n = 573) with ESR1mut had less favorable rwPFS and rwOS versus ESR1 wild-type; no differences were observed for fulvestrant + CDK4/6 inhibitor (n = 348).

Conclusion:

Our study suggests obtaining TBx for CGP at time of de novo/recurrent diagnosis, followed by LBx for detecting acquired GA in 2nd + lines. Reflex TBx should be considered when ctDNA TF < 1%.

01 Oct 2024·European Urology Oncology

Regional Versus Systematic Biopsy in Addition to Targeted Biopsy: Results from a Systematic Review and Meta-analysis

Review

Author: Tedde, Alessandro ; Madonia, Massimo ; Roupret, Morgan ; Schoots, Ivo ; Sanguedolce, Francesco ; Giannarini, Gianluca ; Palou, Joan ; Basile, Giuseppe ; Chernysheva, Daria ; Uleri, Alessandro ; Padhani, Anwar R ; Panebianco, Valeria ; Budeaus, Lars ; Lauwers, Carol Nancy Gianna ; Padhani, Anwar R. ; Baboudjian, Michael ; Breda, Alberto

BACKGROUND AND OBJECTIVE:

Intensification of targeted biopsy (TBx) around a magnetic resonance imaging (MRI)-visible lesion with regional biopsy (RBx) could obviate the need for systematic biopsy (SBx). We aimed to compare the detection yields of clinically significant prostate cancer (csPCa)-defined as International Society of Urological Pathology (ISUP) grade group ≥2-between TBx + RBx and the reference standard (TBx + SBx).

METHODS:

RBx was defined as perilesional or ipsilateral biopsy. A literature search was conducted up to September 2023 using PubMed, Embase, and Web of Science databases. The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines were followed. Included studies were eligible when presenting data from SBx, TBx, and TBx + RBx cores and their detection yields. The Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) criteria were used to assess the risk of bias of the included studies.

KEY FINDINGS AND LIMITATIONS:

Twenty-one studies were included for a meta-analysis. The overall detection yield of csPCa was not statistically different between TBx + SBX and TBx + RBx (46.1% vs 44.2%; odds ratio [OR] 1.07, 95% confidence interval [CI] 0.99-1.16, p = 0.07); similar findings were found also for ISUP grade group ≥3 prostate cancer (PCa; OR 1.06, 95% CI 0.92-1.22, p = 0.43) and in different subgroup analyses. TBx + SBx was associated with higher cancer detection of ISUP grade group 1 PCa (OR 1.16, 95% CI 1.04-1.30, p = 0.008). The main limitations include the retrospective nature of most of the selected studies, heterogeneity of RBx definition, and template.

CONCLUSIONS AND CLINICAL IMPLICATIONS:

Our study supports the use of the TBx + RBx template in the early detection pathway for the detection of csPCa. SBx can be omitted when targeting lesions visible on MRI.

PATIENT SUMMARY:

A prostate biopsy strategy consisting of taking biopsy in and around an magnetic resonance imaging-visible lesion reduces the risk of detecting indolent prostate cancers without affecting the detection of aggressive tumours.

01 Sep 2024·PROSTATE

Image‐guided multiparametric magnetic resonance imaging‐transrectal ultrasound fusion biopsy augmented with a sextant versus an extended template random biopsy: Comparison of cancer detection rates, complication and functional outcomes

Article

Author: Wolf, Steven ; Michael, Zoe ; Taha, Terek ; Ivey, Michael ; Polascik, Thomas J ; Kotamarti, Srinath ; Aminsharifi, Ali ; Deivasigamani, Sriram ; Gupta, Rajan T ; Mottaghi, Mahdi ; Seguier, Denis ; Adams, Eric S

Abstract:

Purpose:

To compare the efficacy of a novel fusion template “reduced six‐core systemic template and multiparametric magnetic resonance imaging/transrectal ultrasound (mpMRI/TRUS) fusion targeted biopsy” (TBx+6c), with mpMRI/TRUS fusion‐targeted biopsy and 12‐core systematic biopsy template (TBx+12c) in the diagnosis of prostate cancer (PCa).

Materials and Methods:

This is an institutional review board approved single‐center observational study involving adult men undergoing fusion‐targeted biopsies for the diagnosis of PCa. Patients were sorted into cohorts of TBx+6c or TBx+12c based on the systematic biopsy template used. The study's main objective was to determine the cancer detection rate (CDR) for overall PCa and clinically significant PCa (csPCa) and the secondary objectives were to compare complication rates and functional outcome differences between the cohort.

Results:

A total of 204 patients met study's inclusion criteria. TBx+6c group had 120 patients, while TBx+12c cohort had 84 patients. The groups had similar baseline characteristics and overall CDR in the TBx+6c cohort was 71.7% versus 79.8%, compared to the TBx+12c (p = 0.18) whereas, the csPCa detection rate in the TBx+6c group was 50.8% versus 54.8% in the TBx+12c group (p = 0.5). TBx+6c cohort had lower overall complication rate of 3% versus 13%, (p = 0.01) and ≥ grade 2 complication rates (1 (1%) vs. 3(4%), p = 0.03) compared to the TBx+12c cohort. There were no differences in IIEF‐5 (p = 0.5) or IPSS (p = 0.1) scores at baseline and 2‐weeks and 6‐weeks post‐biopsy.

Conclusion:

TBx+6c cohort, when compared to the TBx+12c cohort, demonstrated comparable diagnostic performance along with similar functional outcomes and lower complication rates. These results suggest the importance of further exploring the clinical implications of adopting a TBx+6c schema for PCa diagnosis in comparison to the widely used TBx+12c schema through a multicenter randomized controlled trial.

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

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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	usukqtbgcv(ngotchoikm) = wejddwgajb urrdqswbvt (mtayuwbeqj ) View more	Positive	01 May 2003
				0.1% Pemirolast Potassium Ophthalmic Solution QID	usukqtbgcv(ngotchoikm) = eanbluakxw urrdqswbvt (mtayuwbeqj ) View more

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