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

+ [22]

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.

Kowa Co., Ltd.Dr. Reddy's Laboratories SA

+ [4]

Inactive Organization

Exela Pharma Sciences LLC

Eton Pharmaceuticals, Inc.

Applied Biology, Inc.

+ [3]

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

Prostate hyperplasia was induced using testosterone propionate for 8 weeks. Rabbits were divided into two groups: control and experimental. The experimental group was further subdivided into two subgroups: one subgroup was sacrificed after testosterone induction, while the other subgroup received sildenafil (5 mg/kg/day) via intragastric intubation for 8 weeks. The weight of the prostate and relaxation of the bladder neck muscle were assessed. Organ bath experiments evaluated the effect of sildenafil on phenylephrine-precontracted bladder neck muscle strips.

Results:

The mean prostate weight was reduced by 65.34 % after 8 weeks of treatment with sildenafil in animals with BPH. Sildenafil induced significant smooth muscle relaxation of the phenylephrine-contracted bladder neck muscle strips. The mean relaxation value was 2.11 ± 0.13, representing a 32.8 % reduction in contraction percentage. Maximal relaxation was produced at 5.0 × 10⁻⁶ M of sildenafil. Sildenafil induced significant relaxation of the phenylephrine-contracted bladder neck muscle strips. Adding the nitric oxide synthase inhibitor L-NAME inhibited relaxation, whereas sodium nitroprusside, a nitric oxide donor, increased it. Histopathological analysis showed increased papillary projections, acinar areas, and epithelial thickness in the testosterone-treated group. Sildenafil treatment reversed the hypertrophic and hyperplastic changes.

Conclusions:

The results indicate that sildenafil may provide a dual function in the treatment of erectile dysfunction and the relief of urinary tract complications associated with prostatic hypertrophy.

01 Dec 2025·TISSUE & CELL

Pomegranate juice induces vasorelaxation via endothelium-independent mechanisms and calcium channel blockade in rat aortic smooth muscle

Article

Author: Al-Habib, Omar A M ; Adam, Lina N

AIM:

By exploring Pomegranate Juice vasorelaxant effects on rat aortic smooth muscle rings, this study bridges traditional wisdom with modern pharmacological investigation, shedding light on the therapeutic potential of this ancient remedy in cardiovascular disorders.

METHODS:

Thoracic aortas from adult female albino rats were sectioned into rings and mounted in an organ bath with Krebs' solution at 37 °C. Isometric tension was recorded using a force transducer and PowerLab system. Rings were precontracted with phenylephrine (0.01 mM), and pomegranate juice (1.5-5 mg/ml) effects were assessed. Vasorelaxation was compared between rings with and without endothelium. Specific inhibitors (L-NAME, methylene blue, indomethacin) evaluated the roles of nitric oxide synthase, guanylyl cyclase, and prostaglandin I₂. Calcium channel involvement was tested with Nifedipine, an L-type calcium channel blocker.

RESULTS:

PJ (1.5-5 mg/ml) induced a concentration-dependent relaxation of aortic rings precontracted with phenylephrine (PE), with an IC₅₀ of 2.859 ± 0.101 mg/ml, indicating its potent vasorelaxant effect. It achieved a maximum relaxation of 81.8 ± 0.358 %, demonstrating its efficacy in relaxing the tissues. PJ also showed significant relaxation effects on intact aortas, irrespective of endothelial denudation or inhibition of nitric oxide synthase, guanylyl cyclase, and cyclooxygenase (COX) inhibitor pathways. PJ also enhanced relaxation in the presence of nifedipine, indicating a possible additive effect and suggesting involvement of complementary vasorelaxant pathways.

CONCLUSION:

These findings indicate that pomegranate juice (PJ) relaxes rat aortic rings, resulting in both with and without endothelium aortic ring relaxation.

01 Nov 2025·BIOCHEMICAL PHARMACOLOGY

Impact of bradykinin type 2 receptor overexpression on cardiovascular function in mice

Article

Author: Suvorava, Tatsiana ; Kojda, Georg ; Metry, Sara ; Dao, Vu Thao-Vi ; Fischer, Jens W

Bradykinin is an endogenous peptide playing an important role in regulation of vascular function and permeability, but cardiovascular effects of endogenous bradykinin remain incompletely understood. We studied whether genetically engineered overexpression of endothelial bradykinin type 2 receptor (B₂) alters cardiac and vascular function using mice with endothelial-specific overexpression of B₂ (B₂^tg) and their transgene-negative littermates (B₂ⁿ). In the aorta, brain-stem and skeletal muscle of B₂^tg human BDKRB2 were exclusively expressed, and B₂-overexpression was evident by a significant upregulation of B₂ protein. Endothelium-dependent aortic relaxation and responses to phenylephrine or the nitric oxide (NO) donor measured ex vivo were unaffected by the transgene. In contrast, bradykinin induced constriction in B₂ⁿ, but i vasorelaxation in B₂^tg that was sensitive to inhibition of NO-synthase (NOS). In vivo assessment of endothelial function by flow-mediated dilation revealed no changes in B₂^tg as compared to B₂ⁿ. Likewise, transthoracic echocardiography showed no effect of B₂ overexpression on cardiac function. In contrast, decreased systolic blood pressure and bradycardia were observed in B₂^tg. The decrease in blood pressure in B₂^tg remained following inhibition of cyclooxygenase and NOS, but was completely abolished by the selective B₂ antagonist icatibant. Thus, endothelial-specific B₂-overexpression induced mild hypotension and bradycardia while having no effect on flow-mediated dilation or several cardiac function parameters. These minor effects of endothelial-specific B₂ overexpression in healthy mice suggest that alterations of endogenous bradykinin generation may not be associated with derangements of cardiovascular functions, however, the long-term safety of continuous changes of bradykinin in cardiovascular comorbidities deserves further rigorous clinical investigation.

219

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


NCT05890027 (CTgov)	Phase 4	Blepharoptosis	18	Phenylephrine	utkwrzzhdq(lymvszdpvf) = dcnuagypns wbobuhdawu (mypvoiigod, 0.91) View more	-	22 Aug 2025
EURETINA2024 Manual	Not Applicable	-	53	Tropicamide + Phenylephrine hydrochloride	srcnvaxfxo(ywersfsdiq) = khrctiqyil wadmflbyyo (hdnojnpkqz ) View more	Positive	19 Sep 2024
NCT04419662 (Pubmed \| Acta Anaesthesiol Scand)	Phase 4	Anesthesia	-	Phenylephrine infusion	rayyqclkqx(nfuwlsnxgl) = ltjqrxektm bthkkvcvbl (jjhcirzvwt, 3.6 - 5.4) View more	-	01 Aug 2023
NCT00762567 (Pubmed \| Pulm Ther)	Phase 1	-	36	Phenylephrine HCl	qzlvuriupf(eifxedjjhn) = ugzagornin ygvnfkqwch (qyurbymggz ) View more	-	08 Dec 2022
NCT03849508 (Pubmed \| Anesth Analg)	Phase 4	Anesthesia Maintenance	124	Norepinephrine	mmyjpaosnx(vjpigrrwys): ARD = -2.4 (95% CI, -4.4 to -0.5) View more	Positive	24 Oct 2022
NCT03849508 (Pubmed \| Anesth Analg)	Phase 4	Anesthesia Maintenance	124	Phenylephrine		Positive	24 Oct 2022
NCT05439460 (CTgov)	Phase 4	Pulmonary hypertensive crisis \| Pulmonary Arterial Hypertension	15	Phenylephrine (Phenylephrine)	kdgtsmlmqt(jzsfqgcuby) = pnhfidletv oegolwkfcs (lhgldlejyk, 0.7) View more	-	05 Aug 2022
NCT05439460 (CTgov)	Phase 4		15	Arginine Vasopressin (Arginine Vasopressin)	kdgtsmlmqt(jzsfqgcuby) = moykrcxuww oegolwkfcs (lhgldlejyk, 0.41) View more	-	05 Aug 2022
NCT00458003 (CTgov)	Not Applicable	Preeclamptic Toxemia \| Hypotension	110	phenylephrine (Phenylephrine)	yubcxhnsfc(ugbgmvdthj) = bsahkdxaxr bimceifayk (jzzqgqkzbp, .07) View more	-	02 Jun 2022
NCT00458003 (CTgov)	Not Applicable	Preeclamptic Toxemia \| Hypotension	110	Ephedrine (Ephedrine)	yubcxhnsfc(ugbgmvdthj) = rehcdroybr bimceifayk (jzzqgqkzbp, .1) View more	-	02 Jun 2022
AAO2021	Phase 3	Anesthesia	-	Intracameral fixed combination tropicamide 0.02%, phenylephrine 0.31%, lidocaine 1%	pkfhotpqkl(gpsxuaiwwa) = tvkkeecyxu zrnuatkyco (quamgcubbw )	Positive	13 Nov 2021
NCT03615508 (CTgov)	Phase 4	Horner Syndrome	1	10% phenylephrine	mmebzsbtff(jboqsielac) = iqtzexopmf cdyvvvgkwq (eycrtahdum, ujhqqlscem - wxakowjciq) View more	-	14 Oct 2020
NCT02025426 (CTgov)	Phase 4	Pre-Eclampsia	13	Phenylephrine (Phenylephrine)	maebhtgieg(kwjxvgxfvk) = jhzffjqpcp ofebmjjrmk (mcyzmllkec, 29.32) View more	-	14 Oct 2020
NCT02025426 (CTgov)	Phase 4	Pre-Eclampsia	13	Ephedrine (Ephedrine)	maebhtgieg(kwjxvgxfvk) = emkdygnvpj ofebmjjrmk (mcyzmllkec, 7.23) View more	-	14 Oct 2020