Delving into the Latest Updates on Phenylephrine Hydrochloride with Synapse

Overview

Basic Info

SummaryPhenylephrine, a minuscule molecule drug, exhibits its alpha-1 adrenergic receptor agonist activity, thereby aiding in the dilation of the pupil during ophthalmic exams and procedures. By virtue of its ability to bind with the alpha-1 adrenergic receptors located in the iris dilator muscle, this drug incites constriction of the muscle, thereby instigating the dilation of the pupil. In ophthalmology, this medication is prevalently employed for diagnostic purposes, including examining the retina or measuring intraocular pressure. Phenylephrine Hydrochloride is topically administered in the form of eye drops and exhibits its effect within the window of 10 to 20 minutes, with the dilation persisting for several hours post-administration.

Drug Type

Small molecule drug

Synonyms

(-)-m-hydroxy-α-(methylaminomethyl)benzyl alcohol, fenilefrine, l-(3-Hydroxyphenyl)-N-methylethanolamine

+ [21]

Target

ADRA1

Action

agonists

Mechanism

ADRA1 agonists(Adrenergic receptor alpha-1 agonists)

Therapeutic Areas

Nervous System DiseasesCardiovascular DiseasesEye Diseases+ [2]

Active Indication

AnesthesiaMydriasisHypotension+ [4]

Inactive Indication

Fecal IncontinenceHematologic NeoplasmsMucositis+ [3]

Originator Organization

Kowa Co., Ltd.

Active Organization

Paragon BioTeck, Inc.Alcon Research LLCHikma Pharmaceuticals USA, Inc.

+ [5]

Inactive Organization

Applied Biology, Inc.

S.L.A. Pharma AG

University of Wisconsin

+ [1]

License Organization

Dr. Reddy's Laboratories Ltd.

Eton Pharmaceuticals, Inc.Dr. Reddy's Laboratories SA

+ [3]

Drug Highest PhaseApproved

First Approval Date

Japan (11 Oct 1954),

HypotensionShockTachycardia

RegulationOrphan Drug (European Union)

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Structure/Sequence

Molecular FormulaC9H14ClNO2

InChIKeyOCYSGIYOVXAGKQ-FVGYRXGTSA-N

CAS Registry61-76-7

Inhibition of the renin-angiotensin system prevents vascular dysfunction induced by estrogen deficiency in rats. However, the role of aldosterone in ovarian hormone deficiency-related vascular dysfunction is unclear. Therefore, we aimed to investigate the role of the aldosterone pathway in the endothelial dysfunction observed in isolated resistance and conduit arteries in a model of endogenous female hormone deficiency. Female Wistar rats (8 weeks old) underwent bilateral ovariectomy (Ovx) and were randomly assigned to receive daily treatment with spironolactone (Ovx Spi, 80 mg/kg), placebo (Ovx) and Sham treatment with spironolactone (Sham Spi, 80 mg/kg) or placebo (Sham group) for 60 days. In isolated aortic rings, but not mesenteric resistance arteries, Ovx increased vascular reactivity to phenylephrine that was prevented by spironolactone. Incubation with L-NAME increased the phenylephrine response in the isolated aorta in all groups, but this effect was smaller in Ovx rats. The muted response in the Ovx rats was restored by spironolactone. Apocynin, catalase, SOD, tiron and ML-171 attenuated the vascular reactivity to phenylephrine in the aorta of Ovx rats, but this effect was prevented by spironolactone. Corroborating these findings, the reduction of nitric oxide, and the increases in superoxide anion, hydrogen peroxide, NOX4 and NOX2 protein expression in aorta of Ovx rats were prevented by spironolactone. Therefore, spironolactone treatment prevented endothelial dysfunction in aorta from Ovx rats by increasing nitric oxide bioavailability and reducing NADPH oxidase-derived ROS production, suggesting a potential role of the pathway in the vascular dysfunction produced by female hormone deficiency in rats.

01 Jul 2025·EUROPEAN JOURNAL OF PHARMACOLOGY

Melatonin induces urethral contraction and increases intraurethral pressure via MT1 receptor activation in female rats

Article

Author: Tanahashi, Masayuki ; Kajiro, Masashi ; Yokono, Masanori ; Yanai-Inamura, Hiroko ; Takamatsu, Hajime ; Matsui, Shigeo

Melatonin is released by the pineal gland and exerts numerous physiological effects via specific G protein-coupled receptors named MT₁ and MT₂ receptors. It is well known that melatonin acts as a key regulator of circadian rhythm through the activation of these receptors on the central nervous system. However, the expression and function of melatonin receptors in the lower urinary tract remain unclear. This study aimed to investigate the expression and function of melatonin receptors in female urethra. mRNA expression analysis exhibited high expression of MT₁ and MT₂ receptor mRNA in human and rat female urethra. A study of isolated female rat urethral tissue strips using melatonin receptor agonists and an antagonist strongly revealed that stimulation of melatonin MT₁ receptor induced urethral smooth muscle contraction. Further investigation of the mechanism underlying this melatonin MT₁ receptor-related urethral contraction demonstrated that stimulation of MT₁ receptors in urethra activates intracellular Ca²⁺ mobilization via G_q protein-dependent pathways, resulting in smooth muscle contraction. In vivo studies also revealed that melatonin receptor agonists induced an increase in urethral perfusion pressure in female rats. This is the first study to clearly demonstrate the expression and function of melatonin receptors in the urethra. These findings suggested that activation of MT₁ receptors could be a potential pharmacological target for modulation of urethral function.

01 Jul 2025·JOURNAL OF NUTRITIONAL BIOCHEMISTRY

Linoleic acid modulates vascular reactivity, alters cyclooxygenase-2-derived products, and promotes eutrophic remodeling in small mesenteric arteries of normotensive rats

Article

Author: Padilha, Alessandra Simão ; Marcarini, Wena Dantas ; Ribeiro, Eduardo Hertel ; Almenara, Camila Cruz Pereira ; Stefanon, Ivanita ; Marques, Vinicius Bermond ; Nunes, Dieli Oliveira

Linoleic acid (LA) is a polyunsaturated fatty acid with essential roles in cardiovascular regulation. Despite its known vascular effects, its impact on mesenteric resistance arteries (MRA) in normotensive models remains unclear. This study aimed to determine whether LA induces functional and structural changes in MRA of normotensive rats by modulating endothelial mechanisms. We hypothesized that LA treatment reduces vasoconstrictor reactivity and promotes vascular remodeling via enhanced nitric oxide (NO) bioavailability. Male Wistar rats were treated with LA (15 mg/kg) or vehicle for 15 days. LA did not alter blood pressure, mechanical parameters, or collagen and elastin levels in the MRA, but it increased both external and internal diameters of the vessels, reducing the wall-to-lumen ratio. LA decreased the contractile response to phenylephrine, without affecting responses to acetylcholine or sodium nitroprusside. l-NAME (100 µM) enhanced vasoconstriction to a greater extent in the LA-treated group, associated with increased nitric oxide (NO) bioavailability, independent of inducible NO synthase (iNOS) and phosphatidylinositol 3- kinase (PI3K). The NADPH oxidase pathway had a lesser impact on vasoconstriction in the LA group, although the superoxide anion scavenger tiron (1 mM) and the production of reactive oxygen species showed similar results. Inhibition of ciclooxigenase (COX) and cytochrome-P450 (CYP450) attenuated vascular reactivity in the LA group, with greater involvement of COX-2-derived products. While SC 19220 (EP1 receptor antagonist, 10 µM) reduced vasoconstrictor responses to phenylephrine only in MRA from the LA-treated group, SQ 29.548 (TP receptor antagonist, 1 µM) reduced responses only in controls. In conclusion, LA reduces vasoconstriction, increases NO bioavailability and decreases NADPH oxidase participation associated with alterations in CYP450 and COX-2-derived products.

217

News (Medical) associated with Phenylephrine Hydrochloride

25 Apr 2025

·pharma.economictimes.indiatimes.com

Relief for pharma cos as Delhi HC says cough syrup ban applies prospectively

New Delhi: In a relief to pharma companies, including Glenmark Pharmaceuticals and Zuventus Healthcare , the Delhi High Court on Thursday held that the government's April 15 notification that prohibited the manufacture, sale, and distribution of all fixed-dose combinations (certain cough syrup brands) for those below four years of age will apply prospectively. The notification issued by the Ministry of Health and Welfare , which came into effect immediately on the said date, mandated a manufacturer to include a warning stating ‘fixed-dose combination shall not be used in children below four years of age’ on the label and package insert or promotional literature of the drug. A Division Bench led by Chief Justice DK Upadhaya accepted the concerns of the manufacturers that the notification cannot applied retrospectively as some stocks have been manufactured and were in the market before the ban came into effect on April 15. However, the court asked the companies to issue an advisory to doctors, chemists and retailers that fixed dose combination of drugs shall not in “any circumstances” be prescribed/administered to children below four years of age. Additionally, the judges asked the manufacturers to publish an "unambiguously worded notice" in two national newspapers—one in English and one in Hindi— having nationwide circulation. The size of the notices must be designed to attract the attention of readers, the court said. The notice and advisory shall be published within a week, the court said. However, the manufacturers have been directed to “compulsorily comply” with the notification by mentioning the warning on all their labels and packaging of all stocks manufactured and circulated after April 15. The pharma companies must file an affidavit furnishing details of the stocks manufactured, sold or have been in circulation before April 15, the court said. However, the court clarified that any such public notice published by the pharma companies should not be construed as an advertisement and would not amount to any breach of their drug license conditions. If the pharma companies abide by the conditions regarding the notice, advisory, and undertakings, irrespective of the manufacture and sale of the drug in question, no coercive measures against them will be taken, the court. The court will hear the case for compliance on May 15. Senior counsel Amit Sibal and counsel Ajay Bhargava alleged that the drug manufacturers and other stakeholders were not given any opportunity of hearing before the notification was issued. The directions came on a couple of appeals filed by Glenmark and Zuventus challenging the validity of the April 15 notification issued by the Department of Health and Welfare that prohibited the use of all formulations of the fixed dose combination of chlorpheniramine maleate plus phenylephrine hydrochloride in children below four years of age. The restrictions issued under Section 26A of the Drugs and Cosmetics Act, 1940 were imposed on the recommendations of the Drugs Technical Advisory, citing safety concerns. The prohibited fixed drug combination is a commonly used formulation found in various over-the-counter drugs used to treat colds and allergies. The drugs, widely prescribed and sold under various brand names, include Ascoril Flu Drops and some variants of Alex by Glenmark Pharma. By Indu Bhan ,

23 Apr 2025

·www.prnewswire.com

ProRx Pharma Continues to Expand Preventative Health Portfolio with Six New Products

Expanded Product Line Targets Growing Demand for Proactive Wellness Solutions in Clinics, Med Spas, 503A Pharmacies, and Telehealth Practices Across the United States WEST PALM BEACH, Fla. and EXTON, Pa., April 23, 2025 /PRNewswire/ -- ProRx Pharma, the leading health and wellness 503B outsourcing facility, today announced the addition of six new injectable products designed to support the rising demand for preventive care: Gonadorelin, Liraglutide, Vitamin D3, and Phenylephrine HCl as well as two Tri-Mix injection options. These high-quality standalone injectables are now available for bulk shipping to licensed medical facilities in 26 states and for direct-to-consumer shipping nationwide through ProRx's growing network of 503A pharmacies, clinics, med spas and telehealth providers. "Patients are taking charge of their health like never before," said Kurt Lunkwitz, chief operating officer at ProRx. "Physicians are following suit, integrating wellness therapies into their practices to meet the demand for more proactive, functional care. This trend is only going to continue. The continued expansion of our health and wellness line is a direct response—and a step toward making preventative health more accessible and streamlined." What's New: The Products Each of the six new offerings comes with its own National Drug Code (NDC) number and an extended Beyond Use Date (BUD), providing both flexibility and longer shelf life for providers: Gonadorelin ( 1 mg/mL, 6 mg / 6 mL vial ) A gonadotropin-releasing hormone agonist which is used in fertility medicine and to treat amenorrhea and hypogonadism. Gonadorelin may promote testosterone production; may support fertility, libido, and hormonal balance. Liraglutide ( 0.75 mg, 1 mg, 2 mg, 3 mg [custom dosing] ) A powerful GLP-1 receptor agonist for weight and blood-sugar management. Liraglutide may aid in weight loss, appetite suppression, and blood-sugar control. Vitamin D3 ( 50,000 IU/mL, 5 mL vial ) A high-dose solution for those with critically low vitamin D levels. Vitamin D3 may support immune function, bone health, mood, and Vitamin D repletion. Tri-Mix #1 ( 30 mg / 1 mg / 10 mcg/mL, 5 mL vial ) The first of two strength offerings for erectile dysfunction (ED) therapy. Tri Mix #1 may improve erectile response through smooth muscle relaxation and blood flow. Tri-Mix #2 ( 30 mg / 2 mg / 20 mcg/mL, 5 mL vial ) A stronger ED therapy offering. Tri-Mix #2, may provide more ED support for patients needing increased vasodilation. Phenylephrine HCl ( 0.1% 2 mL vial) A critical safety solution for patients using Tri-Mix therapies. Phenylephrine HCl may reverse prolonged erection or priapism due to ED therapy. The introduction of these six new products comes on the heels of ProRx announcing its first four preventative-care offerings the first week of April: Sermorelin, NAD+, Glutathione and MIC/B6/B12. Exclusive Launch at A4M Conference ProRx is showcasing its full line of preventative-care products at the A4M 33rd Annual Spring Conference taking place April 24-26 in West Palm Beach, Florida. At Booth 527, attendees will get an exclusive first look at all 10 products in the new product line and be able to speak with ProRx's experts about the company's compliance and quality-assurance programs. About ProRx Pharma ProRx Pharma is an FDA-registered cGMP facility focused on providing essential compounded medications to meet the need for medications on the FDA drug shortage and bulks list with an emphasis on preventative health. The company produces products and formulations for medical institutions, physician offices, and 503A pharmacies, with a specialization in producing high-quality products to ensure patients have access to the medications they need during critical shortages. For more information, visit SOURCE ProRx Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug Approval

21 Apr 2025

·pharma.economictimes.indiatimes.com

Pharmacists seek clarity on banned cough syrup stock

New Delhi: Pharmacists have raised questions on the procedure to handle several medicines that were recently banned for use in children below four years of age. In a letter to the Drugs Controller General of India (DCGI), the Indian Pharmaceutical Association (IPA), a national body of pharmacists, has asked for clarity on the stock of banned cough syrups that is already in the distribution channel. Citing safety and effectiveness concerns, India's apex drug regulatory agency had directed manufacturers to stop production, sale and distribution of those fixed dose combination (FDC) medicines with immediate effect. The banned cough syrup brands bearing certain composition and strengths that are widely prescribed and sold include Ascoril Flu and variants of Alex by pharma giant Glenmark, T-Mininc sold by Haleon (formerly GSK) and Maxtra by Zuventus . The IPA has asked if the existing stocks should be returned to the manufacturers or sold till the stocks are exhausted. The body has also asked if the pharmacy can dispense the FDCs in case those are prescribed by a doctor for a child below the age of four years. According to a government notification dated April 15, all formulations of fixed dose combination of chlorpheniramine maleate and phenylephrine hydrochloride have been restricted for manufacture, sale and distribution subject to a condition that the manufacturers will mention the warning "fixed dose combination shall not be used in children below four years of age" in the label and package insert or the promotional literature of the drug. The IPA sought clear guidelines for the sale of combination drugs of paracetamol + chlorpheniramine maleate and phenylephrine hydrochloride. "We suggest that a notification incorporating necessary clarification will give better clarity to authorities, healthcare professionals as well as the public," it said, asking for a prompt response. An industry executive said the government notification came as a surprise and they have sought more time to remove the existing products from the market. "The government should have given some time for this transition. How do they expect us to remove the product from the market with immediate effect... There is utter confusion as even the strengths are not mentioned in the notification," said a company executive on condition of anonymity. By Teena Thacker ,

100 Deals associated with Phenylephrine Hydrochloride

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External Link

KEGG	Wiki	ATC	Drug Bank
D00511	Phenylephrine Hydrochloride	C01CA06 R01BA03 S01FB01	DB00388

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Anesthesia	United States	Dr. Reddy's Laboratories SA	21 Oct 2019
Mydriasis	United States	Paragon BioTeck, Inc.	21 Mar 2013
Hypotension	Japan	Kowa Co., Ltd.	11 Oct 1954
Shock	Japan	Kowa Co., Ltd.	11 Oct 1954
Tachycardia	Japan	Kowa Co., Ltd.	11 Oct 1954

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Fecal Incontinence	Phase 3	United Kingdom	S.L.A. Pharma AG	01 Feb 2007
Syncope, Vasovagal	Phase 2	United States	University of Wisconsin Madison	20 Jul 2021
Hematologic Neoplasms	Phase 2	United States	University of Wisconsin Madison	14 May 2015
radiation oral mucositis	Phase 2	United States	University of Wisconsin	14 May 2015
Urinary Incontinence	Phase 2	Israel	RDD Pharma Ltd.	01 Sep 2009
Sexual Dysfunction, Physiological	Phase 1	United States	Applied Biology, Inc.	09 Jul 2018
Sexual Dysfunctions, Psychological	Phase 1	United States	Applied Biology, Inc.	09 Jul 2018
Mucositis	Phase 1	United States	University of Wisconsin Madison	01 Mar 2010
Stomatitis	Phase 1	United States	University of Wisconsin Madison	01 Mar 2010

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Pubmed \| Int J Obstet Anesth	Not Applicable	-	-	phenylephrine (Intermittent pneumatic compression (IPC))	xfkcyitojs(xetkewokgi) = xmwiqtseta cxgjmcuqso (ignebwyhli )	Positive	01 Nov 2024
				phenylephrine (Control (no IPC))	xfkcyitojs(xetkewokgi) = nwgsbaexof cxgjmcuqso (ignebwyhli )
EURETINA2024 Manual	Not Applicable	-	53	Tropicamide + Phenylephrine hydrochloride	wihqbndqxc(wegwgmmfhi) = ftjeagmkim mszejkggml (dlxbexlmnh ) View more	Positive	19 Sep 2024
NCT04419662 (Pubmed \| Acta Anaesthesiol Scand)	Phase 4	Anesthesia	-	Phenylephrine infusion	nyosjuhtyy(kxszhxcyfl) = bkoegpichi ehvnwkovvk (xykgtenctg, 3.6 - 5.4) View more	-	01 Aug 2023
NCT03849508 (Pubmed \| Anesth Analg)	Phase 4	Anesthesia Maintenance	124	Norepinephrine	yebzybmura(kzuztjaqye): ARD = -2.4 (95% CI, -4.4 to -0.5) View more	Positive	24 Oct 2022
				Phenylephrine
AAO2022	Not Applicable	Ophthalmologic surgical procedures	-	Epinephrine alone	hijzwxqtgn(umzqlwviij) = zqusfeysiu morwmqispe (pjnogsxkmt ) View more	-	29 Sep 2022
				Omidria (intracameral phenylephrine and ketorolac)	hijzwxqtgn(umzqlwviij) = vcbrbhelks morwmqispe (pjnogsxkmt ) View more
NCT05439460 (CTgov)	Phase 4	Pulmonary hypertensive crisis \| Pulmonary Arterial Hypertension	15	phenylephrine (Phenylephrine)	nhmtqkerrz(vjgvrxgitd) = qajwlvrqpj weryhcdywj (wnyxlsulpu, 0.7) View more	-	05 Aug 2022
				Arginine Vasopressin (Arginine Vasopressin)	nhmtqkerrz(vjgvrxgitd) = vbcuqlfilm weryhcdywj (wnyxlsulpu, 0.41) View more
NCT00458003 (CTgov)	Not Applicable	Preeclamptic Toxemia \| Hypotension	110	phenylephrine (Phenylephrine)	jsldgosuix(rwcmcugwzj) = beobcjpyya bxjrkcmiyf (xnmwglvzoj, .07) View more	-	02 Jun 2022
				Ephedrine (Ephedrine)	jsldgosuix(rwcmcugwzj) = tthchrcfpy bxjrkcmiyf (xnmwglvzoj, .1) View more
ATS2022	Not Applicable	Hemorrhage	-	Vasoactive Medications (After Protocol Implementation)	hdjvuxzflr(mcktbqogia) = gjzjrbyuud qtjzcrupfw (koxsypdxri )	-	15 May 2022
ATS2022	Not Applicable	Shock, Septic	-	Norepinephrine with Phenylephrine	eeddappgjg(ohqcsunvvo) = mpdxqsattp xaacvllvcd (jpwpdvkgek, 2.6 - 16.2) View more	-	15 May 2022
				Norepinephrine with Vasopressin	eeddappgjg(ohqcsunvvo) = oxtbqgjwuv xaacvllvcd (jpwpdvkgek, 1.3 - 12.1) View more
AAO2021	Phase 3	Anesthesia	-	Intracameral fixed combination tropicamide 0.02%, phenylephrine 0.31%, lidocaine 1%	kzdxsfpplv(wcmbhwamnz) = crqkztzime loufxlgayp (hxgrhhxqfe )	Positive	13 Nov 2021