Delving into the Latest Updates on Ketotifen Fumarate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Ketotifen fumarate (JP17/USAN), Ketotifen Fumarate Nasal Drops, Ketotifen Fumarate Nasal Spray

+ [15]

Target

H1 receptor

Mechanism

H1 receptor antagonists(Histamine H1 receptor antagonists)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesCongenital Disorders+ [4]

Active Indication

EczemaPruritusUrticaria+ [6]

Inactive Indication-

Originator Organization

Novartis Pharma AG

Active Organization

Sandoz International GmbH

Jiangsu Yixing Qianjin Pharmacy FactoryNovartis Ophthalmics, Inc.

+ [4]

Inactive Organization

Johnson & Johnson Vision Care, Inc.Alcon Research Ltd.

Drug Highest PhaseApproved

First Approval Date

CH (03 May 1979),

AsthmaChronic UrticariaConjunctivitis, Allergic+ [2]

Regulation-

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Structure

Molecular FormulaC23H23NO5S

InChIKeyYNQQEYBLVYAWNX-WLHGVMLRSA-N

CAS Registry34580-14-8

A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Pharmacokinetics of Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Combination Ophthalmic Solution, Used Two Times Daily in Healthy Adult Subjects and in Pediatric Subjects With a History or Family History of Atopic Disease (Including Allergic Conjunctivitis)

To compare the safety and tolerability of brimonidine tartrate 0.025%/ketotifen fumarate 0.035% combination ophthalmic solution versus its vehicle in healthy adult subjects and in pediatric subjects.

Start Date20 Apr 2023

Sponsor / Collaborator

Bausch & Lomb, Inc.

NCT05616442 / Not yet recruitingPhase 4IIT

Ketotifen in Non-Alcoholic Fatty Liver Disease Patients

The aim of this study is to investigate the safety and efficacy of using ketotifen in patients with NAFLD patients without cirrhosis

Start Date01 Dec 2022

Sponsor / Collaborator

Tanta University

NCT05579730 / CompletedPhase 3

Evaluation of Combination Drug Product Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution Compared to Its Components and Vehicle for the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge Model

To evaluate the efficacy of Combo (Drug Product Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution) compared to its individual components and vehicle in a population of subjects with allergic conjunctivitis:

Start Date18 Nov 2022

Sponsor / Collaborator

Bausch & Lomb, Inc.

100 Clinical Results associated with Ketotifen Fumarate

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100 Translational Medicine associated with Ketotifen Fumarate

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100 Patents (Medical) associated with Ketotifen Fumarate

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202

Literatures (Medical) associated with Ketotifen Fumarate

24 Nov 2023·Medicine

Acute generalized exanthematous pustulosis caused by hydroxychloroquine in a patient with rheumatoid arthritis and CARD14 mutation: Case report

Article

Author: Yao, Xue-Ming ; Ma, Wu-Kai ; Luo, Feng ; Yuan, Xue-Mei ; Xiong, Hong ; Chen, Chang-Ming

Rationale::

Acute generalized exanthematous pustulosis (AGEP) is a serious adverse skin reaction characterized by the rapid appearance of densely distributed, small, sterile pustules with erythema. However, its pathogenesis is not fully understood. Hydroxychloroquine is widely used for the treatment of autoimmune diseases. Some patients presenting with AGEP have IL36RN and CARD14 gene mutations. Our report describes a patient with rheumatoid arthritis and AGEP associated with hydroxychloroquine and a newly discovered CARD14 gene mutation.

Patient concerns::

A 28-year-old woman with rheumatoid arthritis, treated with leflunomide therapy without marked relief of joint pain, developed multiple rashes with pruritis covering the body 5 days after switching to hydroxychloroquine treatment.

Diagnoses::

Based on the patient’s history, symptoms, and histopathological findings, AGEP was diagnosed.

Interventions::

Whole-exome sequencing and Sanger validation revealed no mutations in the IL36RN gene; however, a CARD14 gene mutation was present. The patient was treated using ketotifen fumarate tablets, dexamethasone sodium phosphate, calcium gluconate injection, methylprednisolone injection, vitamins C and B12, hydrocortisone butyrate cream, Reed acne cream, potassium chloride tablets, and pantoprazole enteric-coated capsules.

Outcomes::

The rash improved after 15 days.

Lessons subsections::

There has been little basic research on AGEP-related genetics, and the CARD14 mutation may underlie several pustular rashes, including AGEP and generalized pustular psoriasis. Follow-up studies and further accumulation of patient data are required.

01 Apr 2023·Contact lens & anterior eye : the journal of the British Contact Lens Association

Determining initial ocular comfort differences between 0.7% olopatadine and 0.035% ketotifen fumarate

Article

Author: Kelley, Laurel R ; Pucker, Andrew D ; Logan, Amy ; Lievens, Chris ; Brafford, Randy ; McGwin, Gerald ; Christensen, Mike ; Franklin, Quentin ; Hogan, Catherine

PURPOSE:

To compare the ocular comfort at application of topical, over-the-counter, 0.7% olopatadine and 0.035% ketotifen fumarate anti-allergy eye drops.

METHODS:

This study recruited participants who were minimally symptomatic based upon Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire scores (≤3 units) and who had minimal between-eye inter-ocular comfort differences as judged by visual analog scale scores (VAS; ≤7 units). Baseline comfort was evaluated by eye with a VAS. One drop of 0.7% olopatadine or 0.035% ketotifen fumarate was then applied to the right eye with the alternative drop being immediately applied to the left eye. Participants were next evaluated with the same comfort VAS by eye at drop application, and then at 30 s, 1 min, and 2 min post-application. LogMAR visual acuities and bulbar conjunctival redness were evaluated pre- and post-drop application to judge initial changes.

RESULTS:

This study enrolled 159 participants who had a mean ± SD age of 26.3 ± 7.7 years, and 78.6% of the participants were female. The VAS found that the 0.7% olopatadine drop was more comfortable than the 0.035% ketotifen fumarate drop at all time-points. There were no between-eye differences in LogMAR visual acuities, yet bulbar redness was significantly less in 0.7% olopatadine treated eyes compared 0.035% ketotifen fumarate treated eyes.

CONCLUSION:

This study found that topically applied 0.7% olopatadine drops were initially more comfortable than 0.035% ketotifen fumarate drops.

31 Dec 2022·Pharmaceutical biology

Network pharmacology-based analysis of the mechanism of Saposhnikovia divaricata for the treatment of type I allergy

Article

Author: Wang, Tingting ; Liu, Zhongcheng ; Zhang, Yanfen ; Li, Hui ; Li, Xiangsheng ; Zhao, Yang ; Shao, Yuxin ; Sun, Yizhao

CONTEXT:

Saposhnikovia divaricata (Turcz.) Schischk (Apiaceae) (SD) has various pharmacological activities, but its effects on type I allergy (TIA) have not been comprehensively studied.

OBJECTIVE:

This study evaluates the treatment and molecular mechanisms of SD against TIA.

MATERIALS AND METHODS:

The effective components and action targets of SD were screened using TCMSP database, and allergy-related targets of SD were predicted using GeneCards and OMIM database. The obtained target intersections were imported into David database for GO analysis, and used R software to perform KEGG analysis. The RBL-2H3 cells sensitised by DNP-IgE/DNP-BSA were treated with different concentrations of SD (root decoction, 0.5, 1, and 2 mg/mL), prim-O-glucosylcimifugin (POG, 10, 40, and 80 μg/mL) and the positive control drug-ketotifen fumarate (KF, 30 μM) for 12 h, then subjected to cell degranulation and qPCR analysis.

RESULTS:

Eighteen active compounds of SD and 38 intersection targets were obtained: TIA-related signal pathways mainly include calcium signal pathway, PI3K-Akt signal pathway and MAPK signal pathway. Taking the β-Hex release rate of the model group as the base, the release rate of SD and POG in high dose groups were 43.79% and 57.01%, respectively, which were significantly lower than model group (p < 0.01), and significantly lower than KF group (63.83%, p < 0.01, p < 0.05). SD and POG could down-regulate the expression of related proteins in the Lyn/Syk, PI3K/AKT and MAPK signalling pathways.

DISCUSSION AND CONCLUSION:

Saposhnikovia divaricata could inhibit IgE-induced degranulation of mast cells, providing a scientific basis for further research and clinical applications of SD in TIA treatment.

5

News (Medical) associated with Ketotifen Fumarate

15 Nov 2021

·www.biospace.com

Bayshore Pharmaceuticals Announces Commercial Launch of ANDA Approved Products

Nov. 15, 2021 11:00 UTC SHORT HILLS, N.J.--(BUSINESS WIRE)-- Bayshore Pharmaceuticals, LLC is pleased to introduce three new FDA-approved products to their expanding portfolio. Metolazone Tablets USP, 2.5mg, 5mg and 10 mg, is the generic equivalent of Zaroxolyn Tablets. It is available by prescription only and is indicated for the treatment of high blood pressure and fluid retention. Etodolac Immediate Release Tablets USP, 400 mg and 500 mg, is the generic equivalent of Lodine Tablets. Etodolac is a nonsteroidal anti-inflammatory drug and only available by prescription. Ketotifen Fumarate Ophthalmic Solution, 0.035% (OTC & RX) is the generic equivalent of Zaditor. It is an antihistamine that is indicated for the treatment of itchy eyes. Ketotifen is Bayshore Pharmaceutical’s first ANDA approved product that is available by prescription or as an OTC in the Bayshore Label. “Bayshore is very proud to bring these internal R&D projects through to FDA approval and commercialization. These efforts further exemplify our focus on balancing internally developed products with our continued partnerships with manufacturing partners such as Beximco Pharmaceuticals, in which we can utilize our trade relationships to market & distribute ANDA’s for those companies not set up do so directly,” says Mark Moshier, President of Bayshore Pharmaceuticals. About Bayshore Pharmaceuticals: Bayshore Pharmaceuticals, LLC was established in 2011 in the centrally located area of Short Hills, NJ. As a full-service Sales & Distribution company focusing on FDA-approved generic pharmaceuticals, Bayshore used its extensive knowledge and experience in global API and Finished Dosage Form manufacturing to differentiate itself from other Generic Pharmaceutical Sales & Marketing organizations. In addition to developing its wholly-owned portfolio of generic products, Bayshore successfully utilized its longstanding industry relationships to augment its business by marketing other pharma manufacturer’s ANDA products under the same Bayshore label. With a strong emphasis on Project Management and Supplier & Customer transparency, Bayshore, along with our global manufacturing partners, maintains the highest level of product quality, in full compliance with current Good Manufacturing Practices (cGMP). This mission has allowed Bayshore to become one of the most service-oriented and reliable supply partners in the industry. View source version on businesswire.com: Contacts Mark Moshier, President (973) 315-1819 Dena Mando, Vice President Sales & Marketing (973) 315-1824 Source: Bayshore Pharmaceuticals View this news release online at:

28 Oct 2021

·www.biospace.com

Eton Pharmaceuticals Announces Acquisition of Approved Orphan Drug Product Carglumic Acid-Product is the first generic alternative to one of the highest priced pharmaceutical products in the world

DEER PARK, Ill., Oct. 28, 2021 (GLOBE NEWSWIRE) --Eton Pharmaceuticals (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that it has acquired U.S. marketing rights to carglumic acid tablets. The product’s Abbreviated New Drug Application, which is owned by Novitium Pharma, was approved by the U.S. Food and Drug Administration on October 13, 2021. The product is an AB-rated, substitutable generic version of Carbaglu®. “We are pleased to be offering patients a lower cost alternative to one of the most expensive treatments in the world,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals. “With our existing orphan drug commercial footprint and robust patient support services, we believe we are well positioned to commercialize this product. We look forward to working with Novitium to bring the product to patients later this year,” Brynjelsen added. Carbaglu® is widely regarded as one of the highest priced pharmaceutical products in the world, with the annual cost of treatment estimated to exceed $1 million for many patients. The introduction of Eton’s lower cost alternative is expected to save patients and the U.S. healthcare system millions of dollars annually. About Eton Pharmaceuticals Eton Pharmaceuticals, Inc. is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The company currently owns or receives royalties from five FDA-approved products, including ALKINDI® SPRINKLE, Biorphen®, Alaway® Preservative Free, Rezipres®, and carglumic acid, and has five additional products that have been submitted to the FDA. Company Contacts: Eton Pharmaceuticals David Krempa dkrempa@etonpharma.com 612-387-3740

Orphan DrugAcquisition

03 Aug 2021

·www.globenewswire.com

Eton Pharmaceuticals to Report Second Quarter 2021 Financial Results on Monday, August 16, 2021

DEER PARK, Ill., Aug. 03, 2021 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that it will report second quarter 2021 financial and operating results on Monday, August 16, 2021. Management will host a conference call and live audio webcast to discuss these results and provide a business update at 4:30 p.m. ET (3:30 p.m. CT). The live webcast can be accessed on the investors section of Eton’s website at . The conference call can be accessed by dialing 1-866-795-8473 (domestic) or 1-470-495-9161 (international) and refer to conference ID 2454465. An archived webcast will be available on Eton’s website approximately two hours after the completion of the event and for 30 days thereafter. About Eton PharmaceuticalsEton Pharmaceuticals, Inc. is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The company currently owns or receives royalties from four FDA-approved products, including ALKINDI® SPRINKLE, Biorphen®, Alaway® Preservative Free, and Rezipres® and has five additional products that have been submitted to the FDA. Investor Contact:David Krempadkrempa@etonpharma.com612-387-3740

AntibodyFinancial Statement

100 Deals associated with Ketotifen Fumarate

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External Link

KEGG	Wiki	ATC	Drug Bank
D01332	Ketotifen Fumarate	S01GX08 R06AX17	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Eczema	JP	Sun Pharma Japan Ltd.	30 Apr 1986
Pruritus	JP	Sun Pharma Japan Ltd.	30 Apr 1986
Urticaria	JP	Sun Pharma Japan Ltd.	30 Apr 1986
Asthma	CH	Novartis Pharma AG	03 May 1979
Chronic Urticaria	CH	Sandoz International GmbH	03 May 1979
Conjunctivitis, Allergic	CH	Sandoz International GmbH	03 May 1979
Dermatitis, Atopic	CH	Sandoz International GmbH	03 May 1979
Rhinitis, Allergic	CH	Sandoz International GmbH	03 May 1979

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Seasonal allergic conjunctivitis	Phase 3	US	Bausch & Lomb, Inc.	18 Nov 2022

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ARVO Annual Meeting 2021 (ARVO2021)	Not Applicable	Geographic Atrophy	-	Ketotifen fumarate eye drops	crmuhuygmk(brxtfxvlkz) = qpzrmjdumu jrlpzijxrb (kqiuiaosuy )	Positive	01 Jun 2021
				Phosphate buffer saline eye drops	jhnlfvuevl(vzofxpjsgi) = nwdcerqrht rwawzeipjh (cmgocfwbdf )
AAAAI2012	Not Applicable	Peanut Hypersensitivity eosinophilia	6	Ketotifen	chhuipepwr(ulhylacdmc) = 3 anaphylactic reactions occurred: day-1 placebo patient at 50mg dose (gastrointestinal, cutaneous); day-5 treatment patient at 50mg dose, occurred post exercise, (gastrointestinal, cutaneous, respiratory); day-6 placebo patient at 12mg dose, associated with fever, (gastrointestinal, cutaneous, respiratory), epinephrine was given and patient withdrew from study zsirpnlpkh (zncdkqxlcr ) View more	Positive	01 Feb 2012
				Placebo
ARVO2004	Not Applicable	Acute conjunctivitis	99	Epinastine HCl 0.05%	xwreduzbjw(hrnjmqpysx) = Three (5.9%) epinastine patients and 7 (14.6%) ketotifen patients experienced adverse events. Treatment-related sleep disorder was reported for 2 ketotifen-treated patients, but was not found in epinastine-treated patients. czijxdkjsn (qvxioevyri )	-	01 May 2004
				Ketotifen
ARVO2003	Not Applicable	Conjunctivitis, Allergic HLA-DR+ \| CD29+ \| eotaxin+	19	Ketotifen fumarate 0,05%	xewfccqerp(wouzjlovlf) = exfweoitqv bdxxuewxop (bhgirntvng ) View more	Positive	01 May 2003
ARVO2003	Not Applicable	Conjunctivitis, Allergic	92	Ketotifen fumarate 0.025%	lbptdgevux(szksjhuznb) = uztdwhhnrg tznokqyngo (bhibluapkl )	-	01 May 2003
				Olopatadine HCl 0.1%	lbptdgevux(szksjhuznb) = minpyodslj tznokqyngo (bhibluapkl )
P110 (AAO2000)	Not Applicable	-	-	Ketotifen	cuxrdwlxia(bwaikddxhq) = jchlnzkleu fkuepbcibo (vaddlfbmlp )	Positive	22 Oct 2000