Last update 19 Jun 2024

Betaxolol Hydrochloride

Last update 19 Jun 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

1-(4-(2-(cyclopropylmethoxy)ethyl)phenoxy)-3-((1-methylethyl)amino)-2-propanol, 1-(isopropylamino)-3-[p-(cyclopropylmethoxyethyl)phenoxy]-2-propanol, Betaxolol

+ [15]

Target

β1-adrenergic receptor

Mechanism

β1-adrenergic receptor antagonists(Beta-1 adrenergic receptor antagonists)

Therapeutic Areas

Nervous System DiseasesCardiovascular DiseasesEye Diseases+ [1]

Active Indication

GlaucomaHypertensionAngina Pectoris+ [4]

Inactive Indication-

Originator Organization

Novartis Pharma AG

Active Organization

Novartis Pharmaceuticals Corp.Alcon-Couvreur NVSanofi-Synthelabo, Inc.

+ [2]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

US (30 Aug 1985),

Glaucoma, Open-AngleOcular Hypertension

Regulation-

Structure

Molecular FormulaC18H30ClNO3

InChIKeyCHDPSNLJFOQTRK-UHFFFAOYSA-N

CAS Registry63659-19-8

Clinical Trials associated with Betaxolol Hydrochloride

IRCT20240415061488N1 / RecruitingPhase 3IIT

Evaluation of Betaxolol in improving the Glasgow Outcome Scale Extended (GOSE) of the acute phase of patients with mild to moderate Traumatic Brain Injury: A double blinded randomized Clinical Trial

Start Date21 May 2024

Sponsor / Collaborator-

NCT04767061 / CompletedPhase 4IIT

N-of-1 Trials for Deprescribing Beta-blockers in HFpEF

The purpose of this study is to understand the impact of beta-blockers on physical function in older adults with heart failure. We will achieve this objective by conducting N-of-1 trials. N-of-1 trials are personalized experiments that test different treatment options in an individual patient.

Start Date01 Apr 2021

Sponsor / Collaborator

Weill Medical College of Cornell University

NCT04757584 / CompletedPhase 4IIT

N-of-1 Trials for Deprescribing Beta-blockers in HFpEF

In this study, we will test the feasibility of N-of-1 trials for deprescribing beta-blockers in patients with Heart Failure with Preserved Ejection Fraction. To achieve this objective we will conduct 16 4-period N-of-1 trials (on vs. off) and subsequently interview participants to better understand feasibility and pragmatism. The N-of-1 trials will be iteratively refined in real-time based on this feedback.

Start Date01 Apr 2021

Sponsor / Collaborator

Weill Medical College of Cornell University

[+1]

100 Clinical Results associated with Betaxolol Hydrochloride

100 Translational Medicine associated with Betaxolol Hydrochloride

100 Patents (Medical) associated with Betaxolol Hydrochloride

936

Literatures (Medical) associated with Betaxolol Hydrochloride

31 Dec 2023·Drug delivery

Physicochemical properties and micro-interaction between micro-nanoparticles and anterior corneal multilayer biological interface film for improving drug delivery efficacy: the transformation of tear film turnover mode

Article

Author: Zhang, Yangrong ; Tao, Qi ; Rupenthal, Ilva D ; Liu, Hanyu ; Li, Huihui ; Xiao, Zhenping ; Dai, Fuda ; Hou, Dongzhi ; Yang, Fan ; Li, Wei ; Hu, Jie ; Lin, Huaqing ; Li, Huamei

Recently, various novel drug delivery systems have been developed to overcome ocular barriers in order to improve drug efficacy. We have previously reported that montmorillonite (MT) microspheres (MPs) and solid lipid nanoparticles (SLNs) loaded with the anti-glaucoma drug betaxolol hydrochloride (BHC) exhibited sustained drug release and thus intraocular pressure (IOP) lowering effects. Here, we investigated the effect of physicochemical particle parameters on the micro-interactions with tear film mucins and corneal epithelial cells. Results showed that the MT-BHC SLNs and MT-BHC MPs eye drops significantly prolonged the precorneal retention time due to their higher viscosity and lower surface tension and contact angle compared with the BHC solution, with MT-BHC MPs exhibiting the longest retention due to their stronger hydrophobic surface. The cumulative release of MT-BHC SLNs and MT-BHC MPs was up to 87.78% and 80.43% after 12 h, respectively. Tear elimination pharmacokinetics study further confirmed that the prolonged precorneal retention time of the formulations was due to the micro-interaction between the positively charged formulations and the negatively charged tear film mucins. Moreover, the area under the IOP reduction curve (AUC) of MT-BHC SLNs and MT-BHC MPs was 1.4 and 2.5 times that of the BHC solution. Accordingly, the MT-BHC MPs also exhibit the most consistent and long-lasting IOP-lowering effect. Ocular irritation experiments showed no significant toxicity of either. Taken together, MT MPs may have the potential for more effective glaucoma treatment.

01 Sep 2023·Journal of pharmaceutical and biomedical analysis

Microextraction by packed sorbent of some β-blocker drugs with chitosan@mof-199 bio-composite in human saliva, plasma, and urine samples

Article

Author: Yamini, Yadollah ; Samadifar, Mahsa

The current study introduces microextraction by packed sorbent (MEPS) to extract three beta-blocker drugs (propranolol, atenolol, and betaxolol) from biological samples. The separation and detection of the drugs were performed by high performance liquid chromatography followed by UV detection. A green approach was applied for synthesizing chitosan@MOF-199 bio-composite, which was packed into the initial part of a metal spinal (22 gage). The effective parameters on the adsorption and desorption efficiencies, including sample solution pH, eluent flow rate, cycle numbers, type and volume of eluent solvent were evaluated and optimized. Under optimal conditions linear ranges (LRs = 5-600 µg L^-1), limits of detection (LODs = 1.5-4.5 µg L^-1), and relative standard deviations (RSDs% = 4.7 -5.3% with three replicates and concentration of 100 µg L^-1) were obtained. Relative recoveries (RR%) for plasma (77-99%), saliva (81-108%), and urine (80-112%) samples were obtained. In this study, the drug release profile of propranolol in urine was evaluated. The results showed that the highest amount of propranolol is released 4 h after taking the drug. Based on the obtained results, this is an effective, fast, sensitive, reproducible, green, and user-friendly method for beta-blocker drug extraction in biological samples.

01 Sep 2023·Journal of chromatography. A

MXene nanosheets woven in polyacrylonitrile nanofiber yarns aligned spider web as a highly efficient sorbent for in-tube solid phase microextraction of beta-blockers from biofluids

Article

Author: Yamini, Yadollah ; Ghaemmaghami, Mostafa ; Moosavi, Negar Sabahi

The use of electrospinning has received much attention in the production of nanofiber webs due to its advantages such as flexibility and simplicity. The direct electrospinning of nanofibers in an aligned or twisted form and the production of nanofiber yarns can turn nanofibers into woven fabrics, which leads to an increase in the diversity of nanofiber applications and improves their end-use possibilities. In this work, a victorious nanofiber yarn spinning system was used with the help of a rotating funnel. Yarn formation was studied using a composited polyacrylonitrile (PAN)/MXene polymer solution ejected from two oppositely charged nozzles. Finaly their application for packed-in-tube solid-phase microextraction of β-blocker drugs from biofluids was demonstrated. The separation and quantification of analytes were performed by HPLC-UV instrument. The 3D-yarn PAN/MXene sorbent exhibited high flexibility, porosity, sorbent loading, mechanical stability, and a long lifetime. The characterization of the final nanofiber was carried out utilizing Fourier-transform infrared spectroscopy, field emission scanning electron microscope, energy-dispersive X-ray mapping, transmission electron microscope and X-ray diffraction analysis. Various parameters that affect the extraction efficiency, such as extraction time, pH, ionic strength and flow rate of sample solution, and type, volume and flow rate of eluent, were investigated and optimized. Under optimized conditions, the limits of detection were obtained in the range of 1.5-3.0 μg L^-1. This method demonstrated appropriate linearity for β-blockers in the range of 5.0-1000.0 μg L^-1, with coefficients of determination greater than 0.990. The inter- and intra-assay precisions (RSDs, for n = 3) are in the range of 2.5-3.5%, and 4.5-5.2%, respectively. Finally, the validated method was put in an application for the analysis of atenolol, propranolol and betaxolol in human urine and saliva samples at different hours and acceptable relative recoveries were obtained in the range of 89.5% to 110.4%.

News (Medical) associated with Betaxolol Hydrochloride

05 Oct 2023

·www.fiercepharma.com

Drugmaker KVK Tech pulls batch of beta blockers after finding opioid tablet on packaging line

For patients, an opioid tablet would be tough to distinguish from the intended betaxolol prescription. After workers at Pennsylvania-based KVK Tech found a stray Oxycontin tablet on the packaging line for a batch betaxolol tablets, the company is recalling the batch as a precautionary measure. The Oxycontin pill was found during a line clearance procedure after the beta blockers were already packed up. So far, the generics maker hasn’t heard reports of a foreign tablet appearing in its medicine, according to an FDA statement on the recall. Beta blockers are prescribed for heart problems such as rhythm disorders, angina and hypertension. The meds slow down a patient’s heart rate, making for a dangerous situation if a patient were to accidentally consume an opioid in addition to their beta blockers. The two tablets look almost identical, featuring only minor differences that a patient likely wouldn’t catch, the FDA said. The affected batch has an expiration date of June 2027. The company has notified its distributors and customers and believes that a “small number” of bottles may have been sent out to retail pharmacies. While the Oxycontin mix-up is unique, the company has run into manufacturing issues before. In 2020, the FDA issued KVK Tech a warning letter after finding the company failed to meet testing standards for a weight loss medicine. The same letter detailed issues with the plant’s investigation of foreign particles found in a lot of an ADHD drug. Later that year, KVK received another letter for skirting cleaning protocols, among other shortfalls.

29 Sep 2023

·www.prnewswire.com

KVK-Tech, Inc. Issues Voluntary Nationwide Recall of one lot of Betaxolol Tablets, USP 10 mg (Batch Number: 17853A) as a precautionary measure due to a single foreign tablet found during the line clearance after the batch was packaged

NEWTOWN, Pa., Sept. 29, 2023 /PRNewswire/ -- Company Contact: Name: Susan DiCroce Phone Number: (215) 579-1842 Ext: 1260 Continue Reading Betaxolol HCl Tablets, USP 10 mg Oxycodone HCl Tablets, USP 5 mg Betaxolol Tablets, USP 10 mg Digital Photo of the Principal Display Panel KVK-Tech, Inc. is voluntarily recalling one lot (Batch Number: 17853A; "the batch") of Betaxolol Tablets, USP 10 mg, White, Round, film coated biconvex tablets, debossed "K" above bisect "13" on one side and plain on the other side" to the consumer level. The batch was distributed nationwide to wholesalers and retailers. The batch is being recalled as a precautionary measure due to a single Oxycodone HCl tablet 5 mg foreign tablet found on the packaging line during the line clearance after the subject batch was packaged. KVK has not received any reports of foreign tablet in any bottle of Betaxolol Tablets, USP 10 mg (Batch Number 17853A) at this time. Risk Statement: Risk statement: The betaxolol package insert warns about slowing in the heart rate in elderly patients which is likely to be exacerbated by inadvertent opioid administration. Additionally, some patients prescribed low-dose betaxolol might have compromised heart and lung function that is also likely to be exacerbated by an opioid. Furthermore, there are minor differences in appearance between betaxolol 10 mg tablets and oxycodone 5 mg tablets, not likely to be noticed by a regular user of the 10 mg betaxolol tablet. Specific patient populations such as those with opioid use disorder (OUD) or at risk of OUD, infants, children, and the elderly are likely to be negatively affected by inadvertently receiving an opioid, especially if a substantial number of oxycodone tablets have been introduced into a bottle labeled as betaxolol. Therefore, inadvertent exposure to a controlled substance, such as oxycodone, in that patient population is likely to result in significant slowing in breathing, known as respiratory depression, which is a serious health risk. Betaxolol HCl Tablets are packaged in 50 CC White High-Density Polyethylene (HDPE) bottles, 100 Tablets and 10702-013-01. The affected Betaxolol Tablets, USP 10 mg lot 17853A has labeled expiration as June 2027. KVK notified its distributors and customers by a Recall Notification Letter via email and FedEx overnight mail on 09/26/2023 and is arranging for the return of all recalled product. KVK believes that a small number of bottles may have been distributed to retail pharmacies. Consumers that may have received Betaxolol Tablets, USP 10 mg (Batch Number: 17853A), should stop using and immediately return the product to KVK-Tech, Inc., 110 Terry Drive, Newtown, PA 18940. KVK will arrange to reimburse customers for their costs in purchasing the product. Consumers with questions regarding this recall can contact KVK-Tech Inc., at (215) 579-1842 Ext: 6002 Monday – Friday, 8:00 am – 6:00 pm EST or by email at [email protected]. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online: Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. SOURCE KVK Tech, Inc.

23 Aug 2023

·www.globenewswire.com

Tiziana Life Sciences Announces Appointment of William A. Clementi as Chief Development Officer

Leadership Addition Strengthens Company's Commitment to Advancing Innovative Therapies NEW YORK, Aug. 23, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, is pleased to announce that it has appointed William A. Clementi, Pharm.D., FCP as Chief Development Officer. Dr. Clementi will formally take up the CDO role effective September 1, 2023. In this role, Dr. Clementi will be responsible for overseeing the company's development strategies and advancing its portfolio of groundbreaking therapeutic candidates. Dr. Clementi brings with him a wealth of experience in the biopharmaceutical industry, having held leadership roles at several prominent companies. He has a proven track record of successfully guiding development programs from early stages through clinical trials, regulatory approval, and commercialization. His deep understanding of drug development and his strategic insights will be invaluable as Tiziana continues to advance its pipeline. Dr. Clementi has followed a science-driven career path since completing his NIH Training Fellowship (under John L. McNay M.D. and Thomas M. Ludden Ph.D.). Upon completing his Fellowship research in drug metabolism and vascular smooth muscle relaxation, Dr. Clementi joined the University of Texas Graduate School of Biomedical Sciences (UTGBS) faculty and the College of Pharmacy faculty in Austin, Tx, in the Departments of Medicine and Pharmacology at the Health Sciences Center in San Antonio. His primary responsibilities were interdisciplinary, and he led innovative programs in the Colleges with teaching, research, and clinical commitments. Dr. Clementi directed the Clinical Pharmacokinetic Consultation Service, providing novel computer-based drug dosing to the acute care settings at two major teaching hospitals. Dr. Clementi continued his career in the pharmaceutical industry, joining Synthelabo and the U.S. affiliate Lorex Pharmaceuticals, where he held the Worldwide Director of Market Development position. Lorex and Synthelabo launched three EMA and FDA-approved products (betaxolol, zolpidem, and alfuzosin). In 1991 Dr. Clementi established a regulatory consulting company, Clementi & Associates, Ltd. (dba as Clementi Ltd). Clementi Ltd. provides regulatory and clinical consultation to small companies developing drugs, biologics, cell-based therapies, organ sustainability products and contrast media for medical imaging. Clementi Ltd. has experience with required regulatory submission standards and processes, including orphan designation, exploratory INDs, expanded access INDs, and combination drug-drug and device-drug products. Clementi Ltd also provides high-level cGMP and GCP oversight. Dr. Clementi is a graduate of Boston University and the University of Texas and the College of Pharmacy. Commenting on his new role, William A. Clementi said, "I am excited to join Tiziana Life Sciences and contribute to the advancement of its innovative therapeutic candidates. I am excited to apply my regulatory and drug development experience and skills to Tiziana and contribute to the leadership team. The company's commitment to addressing unmet medical needs and its dedication to scientific excellence are truly inspiring. I look forward to working closely with the talented team at Tiziana to drive the development of novel treatments that have the potential to make a meaningful impact on patients' lives." Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences, expressed his enthusiasm about the appointment, stating, "We are delighted to welcome William to Tiziana as our Chief Development Officer. His extensive experience and leadership in drug development align perfectly with our company's vision to bring transformative therapies to patients in need. As Tiziana enters a critical phase of growth and development, William's expertise will undoubtedly contribute to our success." About Tiziana Life Sciences Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb, has demonstrated a favourable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications. For further inquiries: Tiziana Life Sciences Ltd Paul Spencer, Business Development and Investor Relations +44 (0) 207 495 2379email: info@tizianalifesciences.com Investors:Irina KofflerLifeSci Advisors, LLC+1 646 970 4681ikoffler@lifesciadvisors.com

Executive ChangeOrphan DrugImmunotherapy

100 Deals associated with Betaxolol Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D00598	Betaxolol Hydrochloride	S01ED02 C07AB05	DB00195

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Glaucoma	CN	Alcon-Couvreur NV	15 Dec 2000
Hypertension	CN	Sanofi-Synthelabo, Inc.	31 Oct 2000
Angina Pectoris	JP	Clinigen KK	02 Oct 1992
Essential Hypertension	JP	Clinigen KK	02 Oct 1992
Parenchymal renal hypertension	JP	Clinigen KK	02 Oct 1992
Glaucoma, Open-Angle	US	Sandoz, Inc.	30 Aug 1985
Ocular Hypertension	US	Sandoz, Inc.	30 Aug 1985

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04757584 (CTgov)	Phase 4	Heart failure with normal ejection fraction \| Heart Failure, Diastolic	9	Beta blockers (Beta Blocker ABAB Sequence)	pkhjkzalkf(auuumcmjwq) = ksbqrbromw pshkudeoao (wlruebrcpt, tchswrnmya - qywmgahaaj) View more	-	09 Apr 2024
				Beta blockers (Beta Blocker BABA Sequence)	pkhjkzalkf(auuumcmjwq) = fgshtptqso pshkudeoao (wlruebrcpt, orxkytzwah - bsiwhrbutf) View more
AAO2007	Not Applicable	-	107	Betaxolol 0.25%	etzysltuxk(vkcwarxjbe) = yxmqiexjlb tsihbwjait (lrvfelgkqo )	Positive	12 Nov 2007
				Timolol Gel Forming Solution (TGFS) 0.25%	etzysltuxk(vkcwarxjbe) = nuusihxisj tsihbwjait (lrvfelgkqo )
ARVO2006	Not Applicable	Glaucoma plasma levels of ET-1	12	Dorzolamide BID	pqsprobwhd(yqzqptluas) = bbzsntvxtr huovfewjmn (qjbttydvjz )	Negative	01 May 2006
				Betaxolol BID	pqsprobwhd(yqzqptluas) = eyqebsgtkm huovfewjmn (qjbttydvjz )
ARVO2005	Not Applicable	-	19	Betaxolol Hcl 0.25% suspension	hldftjxurp(vtokencqfq) = gurtczbatt nbpdpthcmp (anjiwpuozz, 168.8)	Negative	01 May 2005
				Betaxolol Hcl 0.50% solution	hldftjxurp(vtokencqfq) = efmbnisvly nbpdpthcmp (anjiwpuozz, 90.5)
ARVO2003	Not Applicable	Macular Edema	37	Betaxolol	xsiizwrmta(ebqbbqbtet) = vmcqqakdpt ftkxoxthfr (hthyrkvqxy )	Positive	01 May 2003
				Placebo	xsiizwrmta(ebqbbqbtet) = kbqzlawblp ftkxoxthfr (hthyrkvqxy )
ARVO2002	Not Applicable	-	34	Betaxolol hydrochloride 1/2% solution	tabfyegzlz(dfljctrwka) = oiieezyant jvukgocahf (kvmjqylwgv ) View more	-	01 Dec 2002
				Placebo	tabfyegzlz(dfljctrwka) = odpdiyicrs jvukgocahf (kvmjqylwgv ) View more

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