Last update 21 Nov 2024
Phenylephrine Hydrochloride
Last update 21 Nov 2024
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, Phenylephrine, Phenylephrine hydrochloride (JP17/USP) + [21] |
Target |
Mechanism ADRA1 agonists(Adrenergic receptor alpha-1 agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date JP (11 Oct 1954), |
RegulationOrphan Drug (EU) |
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Structure
Molecular FormulaC9H13NO2 |
InChIKeySONNWYBIRXJNDC-VIFPVBQESA-N |
CAS Registry59-42-7 |
View All Structures (2)
Related
353
Clinical Trials associated with Phenylephrine Hydrochloride90% Effective Dose of Phenylephrine Infusions for Preventing Postspinal Anesthesia Hypotension Under Intensive and Standard Treatment in Preeclamptic Patients During Cesarean Section
The objective of this study is to investigate the 90% effective dose of phenylephrine infusions for preventing postspinal anesthesia hypotension under intensive and standard treatment in preeclamptic patients during cesarean section
Start Date01 Jul 2025 |
Sponsor / Collaborator |
ED90 of Norepinephrine and Phenylephrine Boluses for Treating Postspinal Anesthesia Hypotension Under Intensive Treatment in Preeclamptic Patients During Cesarean Section
The objective of this study is to investigate the ED90 of norepinephrine and phenylephrine boluses for treating postspinal anesthesia hypotension under intensive treatment in preeclamptic patients during cesarean section
Start Date01 Jul 2025 |
Sponsor / Collaborator |
90% Effective Dose of Phenylephrine Infusions for Preventing Postspinal Anesthesia Hypotension Under Intensive and Standard Treatment During Cesarean Section
The objective of this study is to investigate the 90% effective dose of phenylephrine infusions for preventing postspinal anesthesia hypotension under intensive and standard treatment during cesarean section
Start Date01 Apr 2025 |
Sponsor / Collaborator |
100 Clinical Results associated with Phenylephrine Hydrochloride
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100 Translational Medicine associated with Phenylephrine Hydrochloride
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100 Patents (Medical) associated with Phenylephrine Hydrochloride
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17,284
Literatures (Medical) associated with Phenylephrine Hydrochloride01 Feb 2025·International Journal of Obstetric Anesthesia
Anesthetic management for fetal surgery: Lessons from a single-center experience (2019–2023)
Article
Author: Gielchinsky, Y. ; Tenenbaum-Gavish, K ; Orbach-Zinger, S. ; Azem, K. ; Idelson, A. ; Duvdevani, N.R. ; Tenenbaum-Gavish, K. ; Duvdevani, N R ; Fein, S ; Faruja, A. ; Idelson, A ; Azem, K ; Orbach-Zinger, S ; Gielchinsky, Y ; Fein, S. ; Yosef, L. ; Yosef, L ; Faruja, A
01 Feb 2025·Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy
Green spectrophotometric approaches applied to tertiary mixture for management of common cold and COVID-19 symptoms
Article
Author: Soliman, Rabab M. ; Monir, Hany H. ; Fayez, Yasmin M. ; Fayez, Yasmin M ; Soliman, Rabab M ; Mostafa, Nadia M. ; Rostom, Yasmin ; Mostafa, Nadia M ; Monir, Hany H
01 Jan 2025·Computer Methods and Programs in Biomedicine
Effect of myogenic tone on agonist-mediated vasoconstriction in isolated arteries: A computational study
Article
Author: Pradhan, Ranjan K ; Pradhan, Ranjan K.
153
News (Medical) associated with Phenylephrine Hydrochloride12 Nov 2024
Advanced Phase 3 CHAPERONE study of MicroPine as a treatment of pediatric progressive myopia with preparations for interim analysis this quarter Commenced the manufacture of registration batches of Mydcombi in its second generation Optejet device Announced the U.S. launch and commercial availability of clobetasol propionate ophthalmic suspension 0.05% for the treatment of inflammation and pain following ocular surgery Appointed Andrew Jones as Chief Financial Officer Company to host conference call and webcast today, November 12th, at 4:30 pm ET NEW YORK, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company developing and commercializing advanced products leveraging its proprietary Optejet topical ophthalmic medication dispensing platform, today announced its financial and operating results for the third quarter ended September 30, 2024. Third Quarter 2024 and Recent Business Developments Advanced the Phase 3 CHAPERONE study of MicroPine for pediatric progressive myopia with plans to conduct an interim analysis this quarter. External sources have valued the myopia market at over $3.0 billion annually in the U.S. and China.Announced the U.S. launch and commercial availability of clobetasol propionate ophthalmic suspension 0.05%, which is FDA approved for the treatment of post-operative inflammation and pain following ocular surgery.Announced collaboration agreements with Formosa Pharmaceuticals, Senju Pharmaceutical Co., Ltd. and SGN Nanopharma to develop novel therapeutics for use with Eyenovia’s Optejet® dispenser as potential treatments for dry eye disease, estimated to be a $5 billion global addressable market.Commenced the manufacture of registration batches of Mydcombi in its second generation Optejet device, a key step in the FDA approval process for its state-of-the-art Gen-2 Optejet dispensing platform.Reported training and shipping Mydcombi to 230 new offices from April through September 30th,2024.Appointed Andrew Jones as Chief Financial Officer.Raised combined net proceeds of $10.7 million. Michael Rowe, Chief Executive Officer, commented, “We achieved another significant commercial milestone during the third quarter with the U.S. launch of clobetasol, the first new ocular steroid approved in over 15 years. Clobetasol perfectly complements our mydriasis product, Mydcombi, and allows us to further leverage our sales force while adding significant value to eye doctors and surgeons. We also experienced accelerating sales momentum with Mydcombi, now having reached 230 offices as of September 30th. “We also took a meaningful step forward in the development of our Gen-2 Optejet device with the commencement of manufacture of registration batches, with Mydcombi as our lead product. We look forward to submitting for FDA approval of this advanced technology with Mydcombi in 2025, and a possible approval in 2026, if successful. “Regarding MicroPine, which we are developing for pediatric progressive myopia, we are preparing for an interim analysis of the Phase 3 CHAPERONE data this quarter that, if successful, we expect will meaningfully accelerate its remaining development path. We also executed several co-development agreements to evaluate novel therapeutics in our Optejet dispenser as potential treatments for dry eye disease. Together, these indications represent multi-billion-dollar addressable markets in the U.S. alone.” “With two differentiated commercial products, another in late Phase 3 development, multiple opportunities in dry eye, and the advanced Gen-2 Optejet technology platform, I believe we are creating a foundation from which we can drive significant growth and value creation in the months and years to come,” Mr. Rowe concluded. Third Quarter 2024 Financial Review For the third quarter of 2024, net loss was approximately $7.9 million, or $0.11 per share, as compared to a net loss of $7.3 million, or $0.18 per share, for the third quarter of 2023. Research and development expenses totaled approximately $3.5 million for the third quarter of 2024, which was relatively consistent with $3.6 million reported for the third quarter of 2023. For the third quarter of 2024, selling, general and administrative expenses were approximately $3.7 million, compared to $2.9 million for the third quarter of 2023, an increase of approximately 27.3% reflecting the establishment of the Company’s sales force in 2024. Total operating expenses for the third quarter of 2024 were approximately $7.2 million, compared to approximately $6.5 million for the third quarter of 2023. This represents an increase of approximately 10.6%. The third quarter 2024 operating expense figure includes approximately $1.2 million of non-cash expenses. As of September 30, 2024, the Company’s unrestricted cash and cash equivalents were approximately $7.2 million. Eyenovia continues to evaluate a range of options to secure long-term financing. Conference Call and Webcast The conference call is scheduled to begin at 4:30 pm ET today, November 12th. Participants should dial 1-877-407-9039 (domestic) or 1-201-689-8470 (international), and reference conference ID 13748714. To access the Call me™ feature, which avoids having to wait for an operator, click here. A live webcast of the conference call will also be available here and on the investor relations page of the Company's corporate website at www.eyenovia.com. After the live webcast, the event will be archived on Eyenovia’s website for one year. PLEASE GO TO MYDCOMBI.COM FOR IMPORTANT SAFETY INFORMATION for MYDCOMBI™ (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% PLEASE GO TO CLOBETASOLBID.COM FOR IMPORTANT SAFETY INFORMATION for Clobetasol Proprionate Ophthalmic Suspension 0.05% About Eyenovia, Inc. Eyenovia, Inc. (NASDAQ: EYEN) is an ophthalmic technology company developing and commercializing advanced products leveraging its proprietary Optejet topical ophthalmic medication dispensing platform. The Optejet is especially useful in chronic front-of-the-eye diseases due to its ease of use, enhanced safety and tolerability, and potential for superior compliance versus standard eye drops. Together, these benefits may combine to produce better treatment options and outcomes for patients and providers. The company’s pre-NDA candidate, MicroPine, is being developed for pediatric progressive myopia, a global epidemic impacting hundreds of millions of children worldwide and representing a multi-billion-dollar addressable market. The company’s current commercial portfolio includes clobetasol propionate ophthalmic suspension, 0.05%, for post-surgical pain and inflammation, and Mydcombi® for mydriasis. Eyenovia has also secured licensing and development agreements for additional multi-billion-dollar indications where the Optejet may be advantageous, including dry eye. For more information, visit Eyenovia.com. The Eyenovia Corporate Information slide deck may be found at ir.eyenovia.com/events-and-presentations. Forward-Looking Statements Except for historical information, all of the statements, expectations and assumptions contained in this press release are forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions, including statements regarding the plans, strategies and objectives of management, statements regarding future capital requirements, and estimated market opportunities for our products, product candidates and platform technology. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may, and in some cases are likely to, differ materially from what is expressed or forecasted in the forward-looking statements. In addition, such statements could be affected by risks and uncertainties related to, among other things: the availability of sufficient financial resources to continue clinical development and commercialization of our products; risks of our clinical trials, including, but not limited to, the costs, design, initiation and enrollment, timing, progress and results of such trials; the timing of, and our ability to submit applications for, obtaining and maintaining regulatory approvals for our product candidates; the potential impacts of any disruptions on our supply chain, including the availability of sufficient components and materials used in our products and product candidates; the potential advantages of our products, product candidates and platform technology; the rate and degree of market acceptance and clinical utility of our products and product candidates; our estimates regarding the potential market opportunity for our products and product candidates; reliance on third parties to develop and commercialize our products and product candidates; the ability of us and our partners to timely develop, implement and maintain manufacturing, commercialization and marketing capabilities and strategies for our products and product candidates; the risk of defects in, or returns of, our products; intellectual property risks; changes in legal, regulatory and legislative environments in the markets in which we operate and the impact of these changes on our ability to obtain regulatory approval for our products; our competitive position; and other risks described from time to time in the “Risk Factors” section of our filings with the U.S. Securities and Exchange Commission, including those described in our Annual Report on Form 10-K as well as our Quarterly Reports on Form 10-Q, and supplemented from time to time by our Current Reports on Form 8-K. Any forward-looking statements speak only as of the date on which they are made, and except as may be required under applicable securities laws, Eyenovia does not undertake any obligation to update any forward-looking statements. Eyenovia Contact:Eyenovia, Inc.Andrew JonesChief Financial Officerajones@eyenovia.com Eyenovia Investor Contact:Eric RibnerLifeSci Advisors, LLCeric@lifesciadvisors.com(646) 751-4363 Eyenovia Media Contact:Eyenovia, Inc.Norbert LoweVice President, Commercial Operationsnlowe@eyenovia.com
EYENOVIA, INC.Condensed Balance Sheets
September 30, December 31, 2024 2023 (unaudited) Assets
Current Assets Cash and cash equivalents$7,188,129 $14,849,057 Inventories 2,967,256 109,798 Deferred clinical supply costs 408,832 4,256,793 License fee and expense reimbursements receivable 137,594 123,833 Security deposits, current - 1,506 Prepaid expenses and other current assets 987,754 1,365,731
Total Current Assets 11,689,565 20,706,718
Property and equipment, net 2,752,404 3,374,384 Security deposits, non-current 197,526 197,168 Intangible assets 6,122,945 2,122,945 Prepaid expenses, non-current 46,520 - Operating lease right-of-use asset 1,275,690 1,666,718 Equipment deposits 711,441 711,441
Total Assets $22,796,091 $28,779,374
Liabilities and Stockholders' Equity
Current Liabilities: Accounts payable$1,573,940 $1,753,172 Accrued compensation 1,656,832 1,658,613 Accrued expenses and other current liabilities 2,518,086 287,928 Operating lease liabilities - current portion 604,647 501,250 Notes payable - current portion, net of debt discount of $562,711 and $503,914 as of September 30, 2024 and December 31, 2023, respectively 6,168,593 5,329,419 Convertible notes payable - current portion, net of debt discount of $72,467 and $0 as of September 30, 2024 and December 31, 2023, respectively 3,260,866 -
Total Current Liabilities 15,782,964 9,530,382
Accrued expenses and other non-current liabilities 316,275 - Operating lease liabilities - non-current portion 836,434 1,292,667 Notes payable - non-current portion, net of debt discount of $0 and $448,367 as of September 30, 2024 and December 31, 2023, respectively 637,500 4,355,800 Convertible notes payable - non-current portion, net of debt discount of $163,051 and $398,569 as of September 30, 2024 and December 31, 2023, respectively 1,503,615 4,601,431
Total Liabilities 19,076,788 19,780,280
Stockholders' Equity: Preferred stock, $0.0001 par value, 6,000,000 shares authorized; 0 shares issued and outstanding as of September 30, 2024 and December 31, 2023 - - Common stock, $0.0001 par value, 300,000,000 shares authorized; 86,375,958 and 45,553,026 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively 8,638 4,555 Additional paid-in capital 179,065,877 154,486,098 Accumulated deficit (175,355,212) (145,491,559)
Total Stockholders' Equity 3,719,303 8,999,094
Total Liabilities and Stockholders' Equity$22,796,091 $28,779,374
EYENOVIA, INC. Condensed Statements of Operations (unaudited)
For the Three Months Ended For the Nine Months Ended September 30, September 30, 2024 2023 2024 2023 Operating Income
Revenue$1,625 $1,198 $29,243 $1,198 Cost of revenue (132,522) (13,416) (825,910) (13,416) Gross Loss (130,897) (12,218) (796,667) (12,218)
Operating Expenses:
Research and development 3,471,939 3,578,113 12,500,713 8,911,124 Selling, general and administrative 3,729,091 2,929,855 11,125,115 9,016,550 Reacquisition of license rights - - 4,864,600 - Total Operating Expenses 7,201,030 6,507,968 28,490,428 17,927,674 Loss From Operations (7,331,927) (6,520,186) (29,287,095) (17,939,892)
Other Income (Expense):
Other income (expense), net 1,184 (348,226) (93,394) (157,783) Change in fair value of equity consideration payable - - 1,240,800 - Interest expense (602,109) (679,222) (1,954,768) (1,691,228) Interest income 44,999 208,901 230,804 494,944 Total Other Expense (555,926) (818,547) (576,558) (1,354,067)
Net Loss $(7,887,853) $(7,338,733) $(29,863,653) $(19,293,959)
Net Loss Per Share - Basic and Diluted$(0.11) $(0.18) $(0.53) $(0.50)
Shares Outstanding - Basic and Diluted 69,558,325 40,139,697 56,476,876 38,563,074
Phase 3Financial StatementExecutive ChangeDrug ApprovalLicense out/in
08 Nov 2024
The FDA has proposed the
removal
of oral phenylephrine as an approved active ingredient in over-the-counter (OTC) nasal decongestant products following a comprehensive review that determined that it is ineffective for this use.
The proposal comes after new data and input from the FDA’s Nonprescription Drug Advisory Committee concluded that oral phenylephrine does not reliably relieve nasal congestion at the recommended dosage.
Currently, oral phenylephrine is included in many OTC products as a single active ingredient or in combination with others like acetaminophen. The FDA emphasized that the concerns about ineffectiveness apply solely to oral forms of phenylephrine and not to nasal sprays containing the ingredient, which remain unaffected by this proposal. The proposal does not involve safety concerns but focuses on a lack of efficacy as a nasal decongestant.
The FDA’s review included historical data, which initially supported phenylephrine’s approval as an effective nasal decongestant, and recent studies challenging its effectiveness.
08 Nov 2024
A pharmaceutical ingredient that’s been a key component in nasal decongestants for decades is having its efficacy called into question, and the FDA is now weighing whether to change the compound’s regulatory status — potentially leading to many widely used over-the-counter cold and allergy products being pulled from pharmacy shelves. But before the FDA takes any action, it wants to hear what the public thinks.
The ingredient, oral phenylephrine, by itself and in combination with other active ingredients, is in decongestants sold under numerous brand names, such as Sudafed and Mucinex. All products containing oral phenylephrine continue to be available to consumers for now. But on Thursday, the FDA proposed an order that would remove oral phenylephrine from its non-prescription drugs guidelines, called the OTC Monograph. The regulator emphasized that this proposed order is due to lack of efficacy, not because of safety.
At one time, phenylephrine was rare in decongestants because pseudoephedrine was the preferred active ingredient. But that compound can be made into the methamphetamine. Efforts to curb meth production led to the Combat Methamphetamine Act of 2005, which moved pseudoephedrine-containing drugs behind pharmacy counters. Drugmakers responded by making more products with oral phenylephrine, which is not covered by this law.
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Last year, an FDA advisory committee discussed phenylephrine and unanimously voted that current scientific data do not support the ingredient’s efficacy as a nasal decongestant. The committee raised no concerns about the safety of oral phenylephrine when used at the recommended dose. The FDA now says it has conducted a comprehensive review of all available safety and efficacy data for oral phenylephrine as a nasal decongestant, including historical data used to support the compound 30 years ago. Speaking during a conference call with journalists Thursday, Theresa Michele, director of the FDA’s office of nonprescription drugs, said new data had become available since the advisory committee meeting, which the agency also reviewed.
“At this point, based on the available data, and taking into account the advice of the advisory committee, we are proposing that oral phenylephrine is not effective to relieve nasal congestion at the recommended dose set forth in the monograph,” Michele said.
Phenylephrine is also an ingredient in some nasal spray decongestants. The FDA’s proposal does not extend to such products. The proposed FDA order can be found here. Public comments may be submitted here (use docket number FDA-2024-N-4734 ) through May 7, 2025. After considering the comments, the agency may issue a final order removing oral phenylephrine from its guidelines, which would mean nasal decongestants could no longer contain the compound. Michele said the FDA would then provide manufacturers with time to either reformulate their medicines or remove oral phenylephrine-containing products from the market.
Don’t let the autumn sniffles get you down. Here’s a look back at other recent regulatory news, including U.S. and European actions on several novel medications (alas, no new decongestants):
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Decisions for Drugs and Devices
—The FDA needs more time to review Organon drug Vtama as a treatment for atopic dermatitis. The company said the regulator has pushed out the December target date for a decision by three months to March 12, 2025. Vtama is from Roivant Sciences subsidiary Dermavant, which Organon recently acquired for $175 million up front. Under Dermavant, the topical drug won FDA approval in 2022 as a treatment for plaque psoriasis.
—Novartis cancer drug Scemblix expanded its FDA-approved uses to include the treatment of newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ PML). The tablet, part of a class of drugs called STAMP inhibitors, initially landed accelerated FDA approval in 2021 as a treatment for advanced cases of Ph+ PML.
—The FDA approved Iterum Therapeutics antibiotic Orlynvah. The regulatory decision covers the treatment of uncomplicated urinary tract infections in women who have limited or no oral antibacterial treatment options. The drug, whose main ingredient is sulopenem, is taken as a tablet twice daily for five days.
—Astellas Pharma landed FDA approval for zolbetuximab, brand name Vyloy, as a treatment for gastric or gastroesophageal junction adenocarcinoma. It’s the first FDA approval for a drug targeting the cancer protein claudin 18.2 (CLDN18.2). The regulatory decision specifically covers patients whose cancer is negative for a different cancer protein called HER2. Drugs are already available for HER2-positive cancers.
—In other Astellas news, the Japanese pharma company withdrew its European Medicines Agency application for geographic atrophy drug avacincaptad pegol. The company said it made the decision after discussions with the agency’s Committee for Medicinal Products for Human Use. The drug, administered as a once-monthly eye injection, won FDA approval in geographic atrophy last year and is marketed in the U.S. under the brand name Izervay. Failure to secure approval in Europe will make it harder for Astellas to recoup the $5.9 billion it spent to acquire Iveric Bio, the company that developed the drug.
—Pfizer respiratory syncytial virus vaccine Abrysvo expanded its FDA approval to include adults age 18 through 59, broadening the market for the product. The initial FDA approval of Abrysvo last year covered patients age 60 and older. It’s also approved for use by pregnant individuals as a maternal vaccine; antibodies produced by the mother confer protection against RSV intended to last from the baby’s birth up to six months of age.
—Gilead Sciences’ Trodelvy will no longer be available in the U.S. for treating urothelial carcinoma, an aggressive bladder cancer. After discussions with the FDA, the company decided to voluntarily withdraw the product, which had won accelerated approval in this indication in 2021. In May, the company reported Trodelvy failed its confirmatory Phase 3 test in advanced urothelial carcinoma. The withdrawal in urothelial carcinoma does not affect drug’s approved uses in breast cancer.
—After previous regulatory setbacks, AbbVie finally landed FDA approval for Vyalev, a Parkinson’s disease drug/device combination product that provides 24 hour subcutaneous infusion of the medications foscarbidopa and foslevodopa. Last year, the regulator turned down the product’s application, asking for more information about the pump in the device. The FDA did not raise any questions about safety or efficacy, nor did it ask for another clinical trial. This past June, the agency again turned down AbbVie’s application for issues at the product’s third-party manufacturer.
—There’s a new Pfizer drug for both hemophilia A and B. The FDA approved the antibody drug marstacimab for preventing or reducing frequency of bleeding episodes in patients 12 and older. Pfizer will market the drug under the brand name Hympavzi. As a once-weekly injectable medication, Hympavzi will provide an alternative to IV-infused hemophilia therapies.
—The FDA needs more time to review Intercept Pharmaceuticals’ application seeking full regulatory approval of Ocaliva, which had received accelerated approval in 2016 for the rare liver disease primary biliary cholangitis. Intercept, now a subsidiary of Alfasigma, said the agency did not provide a new date for a regulatory decision.
—Alzheimer’s disease drug Leqembi hit a regulatory obstacle in Australia, where the Therapeutic Goods Administration decided against registering the medication. Eisai said it will request a reconsideration as permitted under Australian law. It’s the second setback for the drug in recent months. Over the summer, the drug received a negative opinion from a European Medicines Agency committee concerned about the risk of severe side effects and limited benefit. Leqembi has approvals in the U.S., Japan, China, and several other markets.
—The FDA approved a Thermo Fisher Scientific companion diagnostic to Voranigo, a Servier Pharmaceuticals’ drug approved over the summer for treating patients whose glioma is driven by mutations to IDH1 or IDH2 enzymes. The diagnostic, called Ion Torrent Oncomine Dx Target Test, identifies patients whose cancer carries the genetic signature making them eligible for treatment with the Servier drug.
—Advanced cases of non-small cell lung cancer can now be treated with a wearable device. The FDA approved Novocure’s Optune Lua, a wearable technology that kills cancer cells with electrical signals administered via electrodes placed on the skin. Novocure’s “tumor-treating field” technology was first approved in 2011 as a treatment for a recurrent type of brain cancer.
—The FDA rejected Zealand Pharma’s dasiglucagon, a drug developed to prevent and treat hypoglycemia in children who have the rare disease congenital hyperinsulinism. According to the Copenhagen-based biotech, the regulator cited issues at a third-party manufacturer. The FDA did not raise any concerns about the drug’s clinical data or safety.
Advisory Committee Outcomes
—An FDA advisory committee voted 11 to 3 that the benefits of Lexicon Pharmaceuticals’ sotagliflozin do not outweigh its risks when used as an adjunct to insulin to treat adults with type 1 diabetes and chronic kidney disease. But some committee members expressed support for use of the drug in subpopulations of patients. Sotagliflozin, given the brand name Zynquista, is expected to receive an FDA decision by Dec. 20. Sotagliflozin was approved last year for the treatment of heart failure and is marketed as Inpefa in this indication.
—The European Medicine Agency’s Committee for Medicinal Products for Human Use yet again recommended against renewing the marketing authorization for Translarna, a PTC Therapeutics drug for Duchenne muscular dystrophy. Translarna received conditional marketing authorization in 2014. After the drug failed its Phase 3 study, the committee twice recommended against renewing the authorization. The latest opinion comes after the EMA directed the committee to reconsider, taking into account “the totality of evidence.” The committee said its reassessment “concluded that the effectiveness of Translarna has not been confirmed.”
—Stealth BioTherapeutics moved a step closer to potential approval of the first drug for Barth syndrome. An FDA advisory committee voted 10 to 6 that Stealth’s drug, elamipretide, was effective at treating the ultra-rare mitochondrial disorder. The committee vote follows several regulatory setbacks, including a 2021 refuse-to-file letter in which the FDA pointed out that elamipretide failed its clinical trial. Stealth maintains there was improvement in a subgroup of patients and the short duration of treatment is the reason for the trial failure. An FDA decision is expected by Jan. 29.
What’s New in Covid-19
—The European Commission granted marketing authorization to Novavax’s updated Covid-19 vaccine, Nuvaxovid. Authorization for the protein-based vaccine covers its use in those age 12 and older. The FDA authorized the updated version of Novavax’s Covid-19 vaccine in September.
—In other Novavax Covid-19 news, the FDA pressed pause on the company’s plans for late-stage testing of a combination flu/Covid-19 vaccine as well as a standalone influenza vaccine. According to Novavax, the clinical hold stems from a report of motor neuropathy in a single patient outside the U.S. who received the combination vaccine in a Phase 2 study. The trial was completed in July 2023 and the serious adverse event was reported in September. Novavax said previous Covid-19 and influenza trials showed no signs of motor neuropathy. The company’s standalone Covid-19 vaccine is unaffected by the clinical hold.
—In Covid-19 and flu testing news, the FDA granted marketing authorization to a Healgen Scientific over-the-counter, at-home test for both pathogens. The OTC Healgen Rapid Check Covid-19/Flu A&B Antigen Test uses a sample from a nasal swab. The authorization covers use of the product by people age 14 and older within five days of the start of symptoms. For children as young as 2, the sample must be collected by an adult.
Drug ApprovalPhase 3VaccineAcquisitionClinical Result
100 Deals associated with Phenylephrine Hydrochloride
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R&D Status
Approved
10 top approved records. to view more data
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| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Anesthesia | US | 21 Oct 2019 | |
| Mydriasis | US | 21 Mar 2013 | |
| Hypotension | JP | 11 Oct 1954 | |
| Shock | JP | 11 Oct 1954 | |
| Tachycardia | JP | 11 Oct 1954 |
Developing
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Syncope, Vasovagal | Phase 2 | US | 20 Jul 2021 | |
| Urinary Incontinence | Phase 2 | IL | 01 Sep 2009 | |
| Neoplasms | Phase 1 | US | 14 May 2015 | |
| radiation oral mucositis | Phase 1 | US | 14 May 2015 | |
| Transplant complication | Phase 1 | US | 14 May 2015 | |
| Mucositis | Phase 1 | US | 01 Mar 2010 | |
| Stomatitis | Phase 1 | US | 01 Mar 2010 | |
| Fecal Incontinence | Phase 1 | GB | 01 Feb 2007 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
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| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
|---|
Not Applicable | 98 | rhlcuojupl(psmrulvxhn) = mvzcakkijx mofkozibjn (gorkldmnkk ) | Positive | 25 May 2024 | |||
rhlcuojupl(psmrulvxhn) = koimewlqor mofkozibjn (gorkldmnkk ) | |||||||
Phase 4 | Anesthesia Maintenance | 124 | ruzfybuftf(cowflhplgt): ARD = -2.4 (95% CI, -4.4 to -0.5) View more | Positive | 24 Oct 2022 | ||
Phase 4 | 15 | (Phenylephrine) | nsklwtbwfk(imhixgtxwc) = jwebujsmrj vmgykcijzg (xrfuepzggd, flvepnrcyc - imzlfcqzmr) View more | - | 05 Aug 2022 | ||
(Arginine Vasopressin) | nsklwtbwfk(imhixgtxwc) = dvghfviyeu vmgykcijzg (xrfuepzggd, agynukurxb - fggggrtgdu) View more | ||||||
Not Applicable | 110 | (Phenylephrine) | dqwjtexnyp(pulzryyjlj) = smmsvpvncw auskauuikn (qozcyubemw, vfesqmjvru - wbzkmevizs) View more | - | 02 Jun 2022 | ||
(Ephedrine) | dqwjtexnyp(pulzryyjlj) = adzeavfmxz auskauuikn (qozcyubemw, mswjdhwupt - dzlvoiczcz) View more | ||||||
Not Applicable | - | (tmwjcvqpto) = jxzsjjadom oskyabphxy (tjmffamamt, -5 to -1) | - | 15 May 2022 | |||
(tmwjcvqpto) = kzkfwntocn oskyabphxy (tjmffamamt, -7 to -2) | |||||||
Phase 4 | 13 | (Phenylephrine) | qhfyscbafq(ngnrgowbzr) = txscnqodvp bqvgszbgiw (rffhkktsrc, nnqhzyambx - aanvlequah) View more | - | 14 Oct 2020 | ||
(Ephedrine) | qhfyscbafq(ngnrgowbzr) = dmxlwgxdrb bqvgszbgiw (rffhkktsrc, givvteioyb - ccqdxwmsod) View more | ||||||
Phase 4 | 668 | qidrcxsblm(oekvulkmor) = dritofglkx tmanwcdwrr (rvxrhjrjwn ) | Positive | 15 Jul 2020 | |||
qidrcxsblm(oekvulkmor) = xzhbgcbngc tmanwcdwrr (rvxrhjrjwn ) | |||||||
Phase 3 | 72 | phenylephrine +ketorolac | (wczwfmnqoj) = There were no notable changes in vital signs or ophthalmological complications in either group. zwhozxehgq (jemxfwfdcm ) View more | Positive | 01 Jun 2020 | ||
Not Applicable | 110 | efrvbweoja(ewxripjace) = mmpqyomqrn ifgnqdnnjm (kqyqrpooss ) | - | 01 Apr 2020 | |||
Not Applicable | - | 29 | (widgyjhwpc) = feuneantzi kxvkziupsa (idqbaplrur ) View more | - | 01 Dec 2019 | ||
(widgyjhwpc) = rpxhyofesj kxvkziupsa (idqbaplrur ) View more |
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