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Last update 23 Jan 2025

Oxymetazoline Hydrochloride

Last update 23 Jan 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

2-(4-tert-butyl-2,6-dimethyl-3-hydroxybenzyl)-2-imidazoline, 3-[(4,5-dihydro-1H-imidazol-2-yl)methyl]-6-(1,1-dimethylethyl)-2,4-dimethylphenol, 6-t-butyl-3-(2-imidazolin-2-ylmethyl)-2,4-dimethylphenol

+ [39]

Target

α1A-AR

Mechanism

α1A-AR agonists(Alpha-1a adrenergic receptor agonists)

Therapeutic Areas

Cardiovascular DiseasesEye DiseasesOtorhinolaryngologic Diseases+ [3]

Active Indication

BlepharoptosisErythemaRosacea+ [3]

Inactive Indication

Fecal IncontinencePresbyopiaSpinal Cord Injuries+ [1]

Originator Organization

Schering-Plough Canada, Inc.

Active Organization

Santen Pharmaceutical Co., Ltd.Santen SASOsmotica Pharmaceutical US LLC

+ [5]

Inactive Organization

Allergan Ltd. (Ireland)

RDD Pharma Ltd.Bayer Healthcare LLC

+ [1]

Drug Highest PhaseApproved

First Approval Date

CA (31 Dec 1964)

RegulationOrphan Drug (EU)

Structure/Sequence

Molecular FormulaC16H25ClN2O

InChIKeyBEEDODBODQVSIM-UHFFFAOYSA-N

CAS Registry2315-02-8

View All Structures (2)

Clinical Trials associated with Oxymetazoline Hydrochloride

NCT06514612

/ Not yet recruitingPhase 3

A Randomised, Double-Masked, Placebo-Controlled Phase 3 Study on the Efficacy and Safety of STN1013800 (Oxymetazoline HCl 0.1% Eye Drops) Used Twice Daily (BID) in the Treatment of Acquired Blepharoptosis

A Randomised, Double-Masked, Placebo-Controlled Phase 3 Study on the Efficacy and Safety of STN1013800 (Oxymetazoline HCl 0.1% Eye Drops) used twice daily (BID) in the Treatment of Acquired Blepharoptosis

Start Date01 Mar 2025

Sponsor / Collaborator

Santen SAS

CTIS2024-513356-15-00

/ RecruitingPhase 3

Start Date30 Dec 2024

Sponsor / Collaborator

Santen, Inc.

NCT06683651

/ RecruitingPhase 3

A Multicenter, Randomized, Double-Masked, Placebo-Controlled Parallel Group Phase III Study to Evaluate the Efficacy and Safety of STN1013800 Ophthalmic Solution in Chinese Patients With Acquired Blepharoptosis

This is a Phase III Study to evaluate the efficacy and safety of STN1013800 Ophthalmic Solution in Chinese Patients with Acquired Blepharoptosis.
At present, there are no medicines for the treatment of acquired blepharoptosis in China.
Therefore, to evaluate the efficacy and safety of 0.1% STN1013800 ophthalmic solution, Vehicle (Placebo) are designed.
For the screening period, 3-7 days were set to confirm the subjects and judge their qualification. Dosage and administration were based on prior clinical trial results approved at 0.1% once daily for 42 days treatment.

Start Date22 Oct 2024

Sponsor / Collaborator

Santen Pharmaceutical Co., Ltd.

100 Clinical Results associated with Oxymetazoline Hydrochloride

100 Translational Medicine associated with Oxymetazoline Hydrochloride

100 Patents (Medical) associated with Oxymetazoline Hydrochloride

1,139

Literatures (Medical) associated with Oxymetazoline Hydrochloride

14 Jan 2025·Journal of Chromatographic Science

Simultaneous Detection Method of 11 Respiratory Drug Substances Including Theobromine, Oxymetazoline, etc. in Adulterated Dietary Supplements Using Liquid Chromatography–Electrospray Ionization–Tandem Mass Spectrometry and Liquid Chromatography–Quadrupole Time-of-Flight Mass Spectrometry Analysis

Article

Author: Lee, Ji Hyun ; Kim, Hyungil ; Shin, Hyunil ; Kim, Nam Sook ; Kim, Mi Jin ; Choi, Hwan Seong

AbstractRecently, the demand for respiratory disease-related products has surged due to the influence of coronavirus disease 2019, prompting warnings about illegal dietary supplements containing unauthorized substances. Additionally, adulterated dietary supplements are continuously detected in open markets, posing significant public health safety problem. In this study, we developed and validated an analytical method for 11 respiratory drug substances using liquid chromatography–electrospray ionization–tandem mass spectrometry (LC–ESI–MS/MS) and proposed optimal conditions for LC–quadrupole time-of-flight MS (LC–QTOF-MS) to determine the fragmentation patterns of each substance. This method underwent thorough validation considering specificity, linearity, limits of detection and quantification, accuracy, precision, matrix effect, stability, etc. All results met international guidelines. These validated methods were applied to 52 dietary supplements advertised for treating respiratory diseases and enhancing respiratory function, among which one sample was found to contain 313.7 mg/g of theobromine. This determination was made by comparing the product ion ratios with the standards and subsequent quantification. To re-confirm the detected substances, their fragmentation patterns were compared with those of the standards using LC–QTOF-MS. In conclusion, the mass-based information, coupled with the LC–ESI–MS/MS method development, can be successfully applied to rapidly identify 11 respiratory drug substances in illegal dietary supplements used for respiratory disease treatment. The developed simultaneous detection method contributes to public health and safety improvements.

01 Jan 2025·Clinical Otolaryngology

The Anaesthetic Efficacy of Tetracaine and Oxymetazoline Compared With Co‐Phenylcaine in Healthy Individuals

Article

Author: Douglas, Richard G. ; Louis, Deanna ; Lengyel, Olivia ; Kim, Raymond ; Hale, Samuel J. M.

ABSTRACTObjectivesNasal anaesthetic‐decongestant sprays are commonly used prior to nasal instrumentation, such as flexible and rigid nasal endoscopy. Co‐phenylcaine (lignocaine 5%, phenylephrine 0.5%, ENT Technologies Pty Ltd., Melbourne, VIC, Australia) is a combination spray commonly used for this purpose. However, lignocaine is less potent than other local anaesthetics, and both active constituents of Co‐phenylcaine have a bitter taste. It was hypothesised that a combination spray containing tetracaine and oxymetazoline would both offer more potent topical anaesthesia and have a better taste.MethodsFour anaesthetic‐decongestant nasal sprays were tested in 10 healthy participants (Co‐phenylcaine, and tetracaine 0.5%, 1% and 2% with oxymetazoline 0.05%). Sensory thresholds were sequentially measured at the head of the inferior turbinate using Semmes‐Weinstein monofilaments over the following hour. Participants also rated taste on a Likert‐style scale, and reported whether they experienced subjective numbness of the maxillary teeth.ResultsA median peak sensory threshold of 60 g (the maximum tested) was observed with Co‐phenylcaine, but this threshold was exceeded by all the tetracaine‐based sprays. Tetracaine 2% with oxymetazoline 0.05% had a significantly more rapid onset than Co‐phenylcaine (4 min vs. 6 min, p < 0.05) and a longer duration of action. Eight participants reported dental numbness after administration of tetracaine 2% with oxymetazoline 0.05%, but only one participant after Co‐phenylcaine. Tetracaine‐based sprays were generally perceived to taste less unpleasant than Co‐phenylcaine.ConclusionTetracaine 2% with oxymetazoline 0.05% is a more potent and rapidly acting anaesthetic‐decongestant spray than Co‐phenylcaine, with a longer duration of action.

01 Dec 2024·International Forum of Allergy & Rhinology

Oxymetazoline as a predictor of turbinate reduction surgery outcomes: Objective support from a prospective, single‐blinded, computational fluid dynamics study

Article

Author: Formanek, Veronica L. ; Chapman, Robbie J. ; Otto, Bradley A. ; Root, Zachary T. ; Wu, Zhenxing ; Schneller, Aspen R. ; Lepley, Thomas J. ; Zhao, Kai ; Kelly, Kathleen M.

AbstractBackgroundA patient's subjective response to topical nasal decongestant is often used to screen for turbinate reduction surgery suitability. However, this anecdotal strategy has not been objectively and quantitatively evaluated.MethodsProspective, longitudinal, and single‐blinded cohort study employing computational fluid dynamic modeling based on computed tomography scans at baseline, 30 min postoxymetazoline, and 2 months postsurgery on 11 patients with chronic turbinate hypertrophy.ResultsNasal obstruction symptom evaluation (NOSE) and visual analogue scale (VAS) obstruction scores significantly improved from baseline to postoxymetazoline and again to postsurgery (NOSE: 71.82 ± 14.19 to 42.27 ± 25.26 to 22.27 ± 21.04; VAS: 6.09 ± 2.41 to 4.14 ± 2.20 to 2.08 ± 1.56; each interaction p < 0.05), with significant correlation between the latter two states (r∼0.37–0.69, p < 0.05). Oxymetazoline had a broader anatomical impact throughout inferior and middle turbinates than surgery (many p < 0.05); however, the improvement in regional airflow is similar (most p > 0.05) and predominantly surrounding the inferior turbinate. Strong postoxymetazoline to postsurgery correlations were observed in decreased nasal resistance (r = 0.79, p < 0.05), increased regional airflow rates (r = ‐0.47 to −0.55, p < 0.05) and regional air/mucosa shear force and heat flux (r = 0.43 to 0.58, p < 0.05); however, only increasing peak heat flux significantly correlated to symptom score improvement (NOSE: r = 0.48, p < 0.05).ConclusionWe present the first objective evidence that the “topical decongestant test” can help predict turbinate reduction surgery outcomes. The predictive effect is driven by similar improvementin regional airflow that leading to improved air/mucosa stimulations (peak heat flux) rather than through reduced nasal resistance.

News (Medical) associated with Oxymetazoline Hydrochloride

21 Nov 2024

·www.businesswire.com

Nasal Sprays Help Alleviate Nasal Congestion

AMERICAN FORK, Utah--( BUSINESS WIRE )--Today, Nathan Jones, CEO of Xlear Inc., a consumer hygiene products company, released this statement regarding the FDA’s proposal to remove popular over-the-counter decongestants, which contain the drug phenylephrine, from the market: “With the FDA concluding that this common decongestant isn’t effective, as we enter cold and flu season, and as families prepare to celebrate the holidays, many Americans need a new answer for the discomfort of sinus congestion,” Jones noted. “For people looking for help, the U.S. Centers for Disease Control (CDC) Guidance, ‘Relief for Symptoms of Colds and Coughs’, ‘instructions’ say to ‘use saline nasal spray to relieve congestion.’ i Similarly, CDC’s ‘Sinus Infection Basics’ say ‘How to Feel Better’ ‘use a . . . saline nasal spray,’” ii he pointed out. “You experience congestion because there is an irritant or pathogen in your upper airway that your body is trying to trap and wash away—your runny nose is your body flushing it out. Saline-based nasal sprays can help speed up that flushing, reduce pathogen load, and make it more effective. It’s commonsense: The faster the bad stuff is gone, the faster you feel better,” Jones added. “For congestion caused by pathogens—like colds and flus—people can enhance that effect by using a nasal spray that contains xylitol. A series of studies show xylitol (a natural sugar) deactivates and/or blocks the adhesion of many types of viruses and bacteria, to your airway cells,” iii Jones continued. Adhesion is the process by which a pathogen attaches to your tissue to initiate infection. Using a nasal spray with xylitol helps block adhesion of these pathogens. For example, a Randomized Controlled (clinical) Trial published in 2022, determined that a saline-nasal spray containing xylitol and other ingredients reduced the rate of COVID-19 infections by 62 percent above placebo. iv “Using a basic saline would be comparable to rinsing your hands with water; using a nasal spray with xylitol, like Xlear , would be comparable to washing your hands with soap. Expect more from your nasal hygiene products. Make sure they have xylitol so you can better and faster clean out the bad stuff while alleviating the congestion,” Jones added. Xlear nasal spray is a saline-based nasal spray containing xylitol. Xlear 12 Hour Nasal Decongestant is a saline-based nasal spray containing xylitol and the decongestant Oxymetazoline HCL. For more information on Xlear please visit www.xlear.com . ____________________________ i https://www-cdc-gov.libproxy1.nus.edu.sg/antibiotic-use/media/pdfs/HCP-Relief-Colds-Cough-85by11-P.pdf ii https://www-cdc-gov.libproxy1.nus.edu.sg/sinus-infection/about/index.html iii For example: T Kontiokari, M Uhari, M Koskela, Antiadhesive effects of xylitol on otopathogenic bacteria., Journal of Antimicrobial Chemotherapy , Volume 41, Issue 5, May 1998, Pages 563–565, https://academic-oup-com.libproxy1.nus.edu.sg/jac/article-abstract/41/5/563/652694?redirectedFrom=fulltext - google_vignette ; Kontiokari, T., Uhari, M., & Koskela, M. (1998). Antiadhesive effects of xylitol on otopathogenic bacteria. The Journal of Antimicrobial Chemotherapy , 41 (5), 563–565, https://academic-oup-com.libproxy1.nus.edu.sg/jac/article-abstract/41/5/563/652694?redirectedFrom=fulltext&login=false ; Jung, Kie Hoon. (2021). Antiviral Efficacy Against Virus Infections in Human-Derived Tracheal/Bronchial Epithelial Cells. Utah State University, https://xlrtmp.com/wp-content/uploads/2023/05/Antiviral-efficacy_USU2021.pdf ; Vega, J. C., et al., (2020). Iota carrageenan and xylitol inhibit SARS-CoV-2 in Vero cell culture. BioRxiv , https://professionals.xlear.com/portfolio/anti-adherence-of-viruses/ ; Ruiz, V., Rodríguez-Cerrato, V., Huelves, L. et al. Adherence of Streptococcus pneumoniae to Polystyrene Plates and Epithelial Cells and the Antiadhesive Potential of Albumin and Xylitol. Pediatr Res 69, 23–27, https://www-nature-com.libproxy1.nus.edu.sg/articles/pr920116 - citeas . iv Damian Balmforth, et al., Evaluating the efficacy and safety of a novel prophylactic nasal spray in the prevention of SARS-CoV-2 infection: A multi-centre, double blind, placebo-controlled, randomised trial., Journal of Clinical Virology, 155; 2022, https://www-sciencedirect-com.libproxy1.nus.edu.sg/science/article/pii/S1386653222001809 .

29 Oct 2024

·www.businesswire.com

NovaBay Pharmaceuticals Board Determines Unsolicited Offer is Superior to Asset Purchase Agreement with PRN Physician Recommended Nutriceuticals, LLC

EMERYVILLE, Calif.--( BUSINESS WIRE )-- NovaBay ® Pharmaceuticals, Inc . (NYSE American: NBY) (“NovaBay” or the “Company”) announces that the Company’s board of directors has determined that an unsolicited and non-binding offer from Refresh Acquisitions BidCo LLC (“Refresh”) for an affiliate of Refresh to acquire the Company’s Avenova ® brand and related assets is a “Superior Proposal” to the Company’s asset purchase agreement with PRN Physician Recommended Nutriceuticals, LLC (“PRN”). Refresh’s unsolicited offer provides for terms that are substantially similar to the contemplated transaction with PRN, except that the Company would receive a purchase price of up to $11.5 million (compared with $9.5 million in the transaction with PRN), subject to a downside net working capital adjustment. Refresh’s unsolicited offer also includes Refresh providing a secured term loan to the Company in the principal amount of $2.0 million, which is expected to be repaid upon closing and deducted from the purchase price. The Company has notified PRN of the board of directors’ determination and that the Company intends to terminate its asset purchase agreement with PRN unless the Company receives a revised proposal from PRN by 11:59 p.m. Pacific time on November 4, 2024, such that the Company’s board of directors determines that Refresh’s unsolicited offer is no longer a Superior Proposal, in accordance with the process provided in the asset purchase agreement with PRN. “After careful consideration, our board of directors determined that the unsolicited offer by Refresh represents greater value for our stockholders while also placing Avenova in highly capable commercial hands,” said Justin Hall, NovaBay CEO. “Refresh is an affiliate company of RVL Pharmaceuticals, which is commercializing Upneeq ® (oxymetazoline hydrochloride ophthalmic solution), 0.1%, the first and only FDA-approved prescription eye drops for adults with low-lying eyelids, also known as acquired blepharoptosis or ptosis. Our Avenova products are highly complementary to this non-surgical solution that quickly lifts eyelids for more awake-looking eyes. Further, RVL Pharmaceuticals and NovaBay are aligned in our shared passion for commercializing products that improve patients’ lives.” The Company’s asset purchase agreement with PRN, in accordance with such agreement, remains in full force and effect, and the Company’s board of directors has not withdrawn or modified its recommendation regarding stockholders approving the pending transaction with PRN. The Company’s transaction with PRN remains subject to certain closing conditions, including receiving stockholder approval. Consistent with its fiduciary duties, the Company’s board of directors conducted a comprehensive evaluation of the Refresh unsolicited offer with assistance from independent financial and legal advisors, before making its determination. About NovaBay Pharmaceuticals, Inc. NovaBay's leading product Avenova ® Lid & Lash Cleansing Spray is often recommended by eyecare professionals for blepharitis and dry eye disease. Manufactured in the U.S., Avenova spray is formulated with NovaBay's patented, proprietary, stable and pure form of hypochlorous acid. All Avenova products are available directly to consumers through online distribution channels such as Amazon.com and Avenova.com . Forward-Looking Statements This release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. These forward-looking statements are based upon the Company and its management’s current expectations, assumptions, estimates, projections and beliefs. Such statements include, but are not limited to, statements regarding the contemplated transaction with PRN, the unsolicited offer by Refresh and related matters. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results or achievements to be materially different and adverse from those expressed in, or implied by, these forward-looking statements. Other risks relating to NovaBay's business, including risks that could cause results to differ materially from those projected in the forward-looking statements in this press release, are detailed in the Company's latest Form 10-K, subsequent Forms 10-Q and/or Form 8-K filings with the Securities and Exchange Commission (the “SEC”) and the Special Meeting Proxy Statement (as defined below), especially under the heading "Risk Factors." The forward-looking statements in this release speak only as of this date, and the Company disclaims any intent or obligation to revise or update publicly any forward-looking statement except as required by law. Additional Information and Where to Find It In connection with the solicitation of proxies, on October 16, 2024, NovaBay filed a definitive proxy statement with the SEC with respect to the special meeting to be held in connection with the proposed asset sale to PRN and a potential voluntary liquidation and dissolution of the Company (the “Special Meeting Proxy Statement”). Promptly after filing the Special Meeting Proxy Statement with the SEC, NovaBay mailed the Special Meeting Proxy Statement and a proxy card to each stockholder entitled to vote at the special meeting to consider the contemplated asset sale to PRN and potential dissolution. STOCKHOLDERS ARE URGED TO READ THE PROXY STATEMENT (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) AND ANY OTHER RELEVANT DOCUMENTS THAT NOVABAY HAS FILED OR WILL FILE WITH THE SEC BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. Stockholders may obtain, free of charge, the Special Meeting Proxy Statement, any amendments or supplements thereto, and any other relevant documents filed by NovaBay with the SEC in connection with the contemplated asset sale to PRN and potential dissolution at the SEC's website ( http://www.sec.gov ) or at the Company’s investor relations website https://novabay.com/investors/ ) or by writing to NovaBay Pharmaceuticals, Inc., Investor Relations, 2000 Powell Street, Suite 1150, Emeryville, CA 94608. The information provided on, or accessible through, our website is not part of this communication, and therefore is not incorporated herein by reference. Participants in the Solicitation NovaBay and its directors and executive officers may be deemed to be participants in the solicitation of proxies from NovaBay's stockholders in connection with the contemplated asset sale to PRN and the potential dissolution. A list of the names of the directors and executive officers of the Company and information regarding their interests in the contemplated asset sale to PRN and the potential dissolution, including their respective ownership of the Company’s common stock and other securities is contained in the Special Meeting Proxy Statement. In addition, information about the Company’s directors and executive officers and their ownership in the Company is set forth in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 and filed with the SEC on March 26, 2024, as amended on March 29, 2024 and as modified or supplemented by any Form 3 or Form 4 filed with the SEC since the date of such filing. Socialize and Stay Informed on NovaBay ’ s Progress Like us on Facebook Follow us on X Connect with NovaBay on LinkedIn Visit NovaBay’s Website Avenova Purchasing Information For NovaBay Avenova purchasing information: Please call 800-890-0329 or email sales@avenova.com Avenova.com

Acquisition

27 Nov 2023

·www.globenewswire.com

RVL Completes Financial Restructuring

Athyrium Provides Capital to Support Long-Term Growth and Exchanges Outstanding Debt into Equity of Certain Reorganized Entities RVL Pharmaceuticals plc Ordinary Shares Expected to be Cancelled in 2024 BRIDGEWATER, N.J., Nov. 27, 2023 (GLOBE NEWSWIRE) -- RVL Pharmaceuticals, Inc. (“RVL” or the “Company”), a specialty pharmaceutical company focused on the commercialization of UPNEEQ® (oxymetazoline hydrochloride ophthalmic solution), 0.1%, for the treatment of acquired blepharoptosis, or droopy eyelids, in adults, today announced that it and its wholly-owned U.S. operating subsidiary RVL Pharmacy, LLC (collectively, the “RVL Subsidiaries”), successfully emerged from their Chapter 11 cases on November 22, 2023 following the confirmation by the United States Bankruptcy Court for the District of Delaware of their Plan of Reorganization (“Plan”) on November 20, 2023. RevitaLid Pharmaceutical Corp., previously the direct parent company of RVL Pharmaceuticals, Inc, concurrently emerged from its Chapter 11 case, though will be wound down under the Plan. “Upon emergence, the RVL Subsidiaries are well-positioned to invest in UPNEEQ, drive their strategic initiatives, and continue to deliver high-quality, innovative ocular and aesthetic solutions for patients and healthcare partners,” said Brian Markison, Chief Executive Officer of the Company. The Plan was unanimously supported by the RVL Subsidiaries’ sole secured lender (funds managed by Athyrium Capital Management, LP (“Athyrium”)) and other key stakeholders. The Company will continue to operate and be supported as a privately held company under the ownership of Athyrium. It is expected the wind-down of the Company’s former public parent company, RVL Pharmaceuticals plc, and its subsidiaries other than the RVL Subsidiaries will promptly commence, and RVL Pharmaceuticals plc’s public equity is expected to be cancelled upon completion of its wind-down during 2024, resulting in no recovery to public shareholders. About the Company RVL Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the commercialization of UPNEEQ® (oxymetazoline hydrochloride ophthalmic solution), 0.1%, for the treatment of acquired blepharoptosis, or low-lying eyelid, in adults. UPNEEQ is the first non-surgical treatment option approved by the FDA for acquired blepharoptosis. For more information, please visit the Company’s website at www.rvlpharma.com. IMPORTANT SAFETY INFORMATION INDICATION UPNEEQ® (oxymetazoline hydrochloride ophthalmic solution), 0.1%, is indicated for the treatment of acquired blepharoptosis in adults. WARNINGS AND PRECAUTIONS Ptosis Association: Ptosis may be associated with neurologic or orbital diseases such as stroke, cerebral aneurysm, Horner syndrome, myasthenia gravis, external ophthalmoplegia, orbital infection, and orbital masses. Consider these conditions in the presence of ptosis with decreased levator muscle function and/or other neurologic signs.Cardiovascular Impact: Alpha-adrenergic agonists as a class may impact blood pressure. Advise UPNEEQ patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension or hypotension to seek medical care if their condition worsens.Use with Caution: Use UPNEEQ with caution in patients with cerebral or coronary insufficiency or Sjögren’s syndrome. Advise patients to seek medical care if signs and symptoms of potentiation of vascular insufficiency develop.Glaucoma Risk: UPNEEQ may increase the risk of angle closure glaucoma in patients with untreated narrow-angle glaucoma. Advise patients to seek immediate medical care if signs and symptoms of acute narrow-angle glaucoma develop.Container Safety: Patients should not touch the tip of the single patient-use container to their eye or to any surface, in order to avoid eye injury or contamination of the solution. ADVERSE REACTIONS Adverse reactions that occurred in 1-5% of subjects treated with UPNEEQ include punctate keratitis, conjunctival hyperemia, dry eye, blurred vision, instillation site pain, eye irritation, and headache. DRUG INTERACTIONS Blood Pressure: Alpha-adrenergic agonists, as a class, may impact blood pressure. Exercise caution when using drugs such as beta-blockers, anti-hypertensives, and/or cardiac glycosides.Metabolism: Caution is advised in patients taking monoamine oxidase inhibitors, which can affect the metabolism and uptake of circulating amines. For inquiries, please contact: Brian Markisonbrianmarkison@rvlpharma.com

100 Deals associated with Oxymetazoline Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D01022	Oxymetazoline Hydrochloride	R01AA05 S01GA04 R01AB07	DB00935

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Blepharoptosis	US	RVL Pharmaceuticals, Inc.	08 Jul 2020
Erythema	US	Mayne Pharma Ltd.	18 Jan 2017
Rosacea	US	Mayne Pharma Ltd.	18 Jan 2017
Hyperemia	JP	Sato Pharmaceutical Co., Ltd.	01 Aug 2007
Nasal Obstruction	CN	Changzhou Yabang Pharmaceutical Co., Ltd.	01 Jan 1992

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Blepharophimosis	Phase 3	-	Santen SAS	01 Mar 2025
Blepharoptosis	Phase 3	JP	Santen Pharmaceutical Co., Ltd.	19 Oct 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05715346 (CTgov)	Phase 1/2	Blepharoptosis	33	LEV102 2.0% (LEV102 Topical Gel, 2.0%)	aycktzmfpc(hnsdibnjtl) = vedndhkbms joudkayhxp (dwghygaygo, wrogqxbhrv - nggzwmbnrg) View more	-	13 Nov 2024
				LEV102 1.0% (LEV102 Topical Gel, 1.0%)	aycktzmfpc(hnsdibnjtl) = mxxctwuhsu joudkayhxp (dwghygaygo, jofqluvneq - zwxfomxvff) View more
NCT04831047 (CTgov)	Phase 4	Eye Redness \| Conjunctivitis \| Blepharoptosis	114	Oxymetazoline hydrochloride 0.1% ophthalmic solution (Upneeq Group)	vnhgnrxxwv(pcftlkjzei) = gthqqeluoj jnynkptmjg (dtlsurpjfp, fshbeejqbr - siyktpxiuf) View more	-	24 Apr 2023
				Placebo (Control Group)	vnhgnrxxwv(pcftlkjzei) = gjarzpdkff jnynkptmjg (dtlsurpjfp, mcyoqgyvkh - hxokzxbcmt) View more
NCT04831047 (Pubmed \| J Plast Reconstr Aesthet Surg)	Not Applicable	Eye Redness \| Conjunctivitis \| Blepharoptosis	114	Topical oxymetazoline 0.1%	glwnfjpzjl(ixhudivynq) = flwevabcca ltkoprmkab (ndplnplfbn )	Positive	09 Feb 2023
NCT04153188 (CTgov)	Phase 4	-	34	The Vbeam® Prima System+Oxymetazoline HCL 1% Cream (Pulsed Dye Laser & Oxymetazoline HCL 1% Cream)	ywnscwijpz(ydnzvbaejb) = hipejzhglx bfogpgylep (oxympnswwv, dwprktzptj - wzryvktrsd) View more	-	18 Mar 2022
				Oxymetazoline HCL 1% Cream (Oxymetazoline HCL 1% Cream)	ywnscwijpz(ydnzvbaejb) = wwfninyfuy bfogpgylep (oxympnswwv, egiepighcs - ucxrcagkjq) View more
NCT01848041 (CTgov)	Phase 1/2	Blepharoptosis	46	RVL-1201 (RVL-1201 Once Daily)	mqsyejkmkn(cmjlufxezf) = rdilakpfwc mbpdofqsgk (agewmjpfjt, hrtuwcyqws - azrmoxieih) View more	-	22 Jul 2021
				RVL-1201 (RVL-1201 Twice Daily)	mqsyejkmkn(cmjlufxezf) = yvgtyqqjta mbpdofqsgk (agewmjpfjt, zncfhskmsw - perpvuhnaq) View more
NCT03954444 (CTgov)	Phase 3	Rosacea	1,105	Oxymetazoline Hydrochloride (Oxymetazoline Hydrochloride Cream, 1%)	vtrtukxkyk(yslggopycv): Mean Difference (Net) = 2.7 (90% CI, -2.6 to 8.0)	-	23 Jun 2021
				Rhofade Cream, 1% (RHOFADE Cream, 1%)
NCT03228914 (CTgov)	Phase 4	Hemorrhage \| Nasal Polyps	20	Oxymetazoline (Oxymetazoline)	suhuwudcqr(zifziiruai) = ofoymvvpjw ectjnqwfum (kqqgrbxplw, twagjayrha - ghijjixyby) View more	-	13 Jan 2021
				Epinephrine (Epinephrine)	suhuwudcqr(zifziiruai) = aoiekrslba ectjnqwfum (kqqgrbxplw, nivjfcyion - veuijhufrw) View more
NCT03352323 (CTgov)	Phase 3	Rosacea \| Erythema	50	Oxymetazoline	(eqdnkjjttx) = unpnicquvm pvvixgaicl (udlzdxtotj, wgndmdpems - igdhpuripg) View more	-	05 Jan 2021
NCT02595528 (CTgov)	Phase 2	Presbyopia	163	AGN-190584 (AGN-190584 Vehicle)	amqjucrmcu(dgdxbpfyzw) = ldfuaypgxm pkniaidmmg (ubxtararjk, jnrupkhqoe - mophxdduqm) View more	-	22 Dec 2020
				AGN-190584 (AGN-190584 Lower Dose)	amqjucrmcu(dgdxbpfyzw) = ignvipdbiu pkniaidmmg (ubxtararjk, ksbszgjsyd - ziixymjbut) View more
NCT02780115 (CTgov)	Phase 2	Presbyopia	151	AGN-190584 Vehicle	tjawxdacgy(vbuzntjpnr) = bkafwchchh mvhfbytyrc (yekogtqbdi, gmwpnamtsh - wwiwkbblam) View more	-	22 Dec 2020

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