The purpose of this study is to evaluate the safety and tolerability of fluphenazine in patients with advanced multiple myeloma. The study will also describe the efficacy of this drug.

Start Date01 Dec 2008

Sponsor / Collaborator

Immune Control, Inc.

NCT00335647 / CompletedPhase 1/2

A Phase I/IIa, Open-Label, Dose-Escalation Study to Determine the Safety, Tolerance, and Preliminary Activity of Intravenous High-Dose Fluphenazine HCI in Patients With Advanced Multiple Myeloma

RATIONALE: Drugs used in chemotherapy, such as fluphenazine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I/II trial is studying the side effects and best dose of fluphenazine and to see how well it works in treating patients with refractory advanced multiple myeloma.

Start Date01 Jan 2006

Sponsor / Collaborator

Immune Control, Inc.

100 Clinical Results associated with Fluphenazine Hydrochloride

100 Translational Medicine associated with Fluphenazine Hydrochloride

100 Patents (Medical) associated with Fluphenazine Hydrochloride

137

Literatures (Medical) associated with Fluphenazine Hydrochloride

01 Jan 2015·Scientia pharmaceutica

Forced Degradation Behaviour of Fluphenazine Hydrochloride by LC and Characterization of its Oxidative Degradation Product by LC–MS/MS

Article

Author: Thummar, Kashyap N ; Sheth, Navin R ; Vachhani, Ashish ; Ghava, Dilip J ; Mistry, Anvi

A novel, stability-indicating high-performance liquid chromatographic (HPLC) method is delivered for the determination of fluphenazine hydrochloride (FPZ) and its degradation products. The forced degradation testing of FPZ was carried out for hydrolytic, oxidative, photolytic, and thermal degradation. The degradation appeared using a reversed-phase C18 column at ambient temperature with a mobile phase comprised of methanol : acetonitrile : (10 mM) ammonium acetate (70:15:15, v/v/v) pH 6.0, adjusted with acetic acid, having a flow rate of 1 ml min(-1) and a detection wavelength at 259 nm. Primarily, the maximum degradation products were formed under oxidative stress conditions. The product was distinguished through LC-MS/MS fragmentation studies. Based on the results, a more complete degradation pathway for the drug could be proposed. The modernized method was found to be precise, accurate, specific, and selective. The method was found to be suitable for the quality control of fluphenazine hydrochloride in the tablet as well as in stability-indicating studies.

01 Dec 2012·Journal of pharmaceutical analysisQ2 · MEDICINE

Simultaneous determination of nortriptyline hydrochloride and fluphenazine hydrochloride in microgram quantities from low dosage forms by liquid chromatography–UV detection

Q2 · MEDICINE

ArticleOA

Author: Ashour, Safwan ; Kattan, Nuha

A novel method for the simultaneous high-performance liquid chromatographic determination of nortriptyline hydrochloride and fluphenazine hydrochloride was developed and validated. Fluvastatin sodium was used as internal standard. The determination was performed on a Hypersil Gold C₈ column (250 mm × 4.6 mm i.d., 5 μm particle size) at 25 °C; the mobile phase, consisting of a mixture of formic acid (0.1 M, pH 2.16)-methanol (33:67, v/v), was delivered at a flow rate of 1.1 mL/min and detector wavelength at 251 nm. The retention time of nortriptyline, fluphenazine and fluvastatin was found to be 5.11, 8.05 and 11.38 min, respectively. Linearity ranges were 5.0-1350.0 and 10.0-1350.0 μg/mL with limit of detection values of 0.72 and 0.31 μg/mL, for nortriptyline and fluphenazine, respectively. Results of assay and recovery studies were statistically evaluated for its accuracy and precision. Correlation coefficients (r²) of the regression equations were greater than 0.999 in all cases. According to the validation results, the proposed method was found to be specific, accurate, precise and could be applied to the simultaneous quantitative analysis of nortriptyline and fluphenazine.

News (Medical) associated with Fluphenazine Hydrochloride

03 Apr 2023

·www.biospace.com

UPSHER-SMITH LAUNCHES FLUPHENAZINE HYDROCHLORIDE TABLETS

MAPLE GROVE, Minn., April 3, 2023 /PRNewswire/ -- Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced the launch of Fluphenazine Hydrochloride Tablets, USP in 1 mg, 2.5 mg, 5 mg, and 10 mg strengths. The fluphenazine hydrochloride tablet market had U.S. sales of approximately $30 million for the 12 months ending January 2023 according to IQVIA. Fluphenazine Hydrochloride Tablets are a generic version of the brand product, Prolixin®.* Product Information For questions about ordering, please call Upsher-Smith at 1-800-654-2299. Please refer to the full Prescribing Information, including Boxed Warning for Fluphenazine Hydrochloride Tablets, USP here. You can also call 1-888-650-3789 to obtain a copy of the full Prescribing Information. You are encouraged to report suspected adverse reactions to Upsher-Smith Laboratories, LLC at 1-855-899-9180 or to the FDA by visiting . About Upsher-Smith Upsher-Smith Laboratories, LLC is a trusted U.S. pharmaceutical company that strives to improve the health and lives of patients through an unwavering commitment to high-quality products and sustainable growth. The company brings brands and generics to a wide array of customers, always backed by its attentive level of service, strong industry relationships, and dedication to uninterrupted supply. For more information, visit . *Prolixin is a registered trademark of E.R. Squibb & Sons, Inc. Prolixin Tablets have been discontinued.

Drug Approval

100 Deals associated with Fluphenazine Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D00791	Fluphenazine Hydrochloride	N05AB02	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Behavioural disorders	US	Schering Corp.	09 Sep 1959

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