. New- onset postoperative atrial fibrillation (POAF) is a common complication after cardiac surgery and its occurrence increases with age. POAF can result in clinically significant morbidity and mortality. The national trend in the US is that the population older than 65 years is increasing, making healthcare expenditure related to POAF to be a major burden on health care system. Effective treatment of POAF is imperative in ensuring quality of care and reduction of costs.
In 2021 there is a projected total of 377,763 cardiovascular surgeries in the US alone with approximately half of which will have POAF with longer postoperative length of stay (+3.9 days) and higher discharge costs (+$13,993) than no-POAF patients (Reference: Ann Thorac Surg. 2015 Jan;99(1):109-14). Amiodarone, the currently used therapy, is often insufficient to prevent POAF and has multiple side-effects. In this study, we expect to improve the incidence of POAF by using a common acne drug (Minocycline) that is safe and that could be incorporated in clinical care of this disease.

Start Date01 Jul 2025

Sponsor / Collaborator

Baystate Medical Center

NCT06699966

/ Not yet recruitingPhase 4IIT

Stony Brook Medicine Anti-Inflammatory Trial

This is an experimental study designed to measure the effect of celecoxib or minocycline on depressive symptoms in unipolar and bipolar depression. Participants will be equally randomized to either celecoxib or minocycline. All participants will complete a battery of clinical and psychological assessments prior to treatment assignment, and again after treatment completion, to assess any changes or improvements in depression.

Start Date30 Jun 2025

Sponsor / Collaborator

Stony Brook University

NCT05605366

/ Not yet recruitingPhase 1IIT

Minocycline in Neurocognitive Outcomes - Sickle Cell Disease

Sickle cell disease (SCD) is a common, inherited blood disorder that primarily affects people of African Ancestry. It has a lot of complications including neurological complications. The neurological complications of SCD are particularly devastating and lead to cognitive decline even in the absence of overt brain injury. In such cases, it is thought that inflammation in the brain maybe partly responsible for the cognitive decline.
The main reasons for this research study are to see 1) how safe and 2) how well minocycline works to try to stop/reverse cognitive decline in people with SCD. People with SCD are at risk for changes in their brain over time that can cause problems with learning, memory, and attention. Part of the reason for this is inflammation within the brain. Minocycline may be able to stop these brain changes by stopping this brain inflammation.
Minocycline is a second-generation tetracycline antibiotic that has been shown to both inhibit neuroinflammation and improve cognitive function in a variety of neurodegenerative and psychiatric disorders but has not yet been studied in SCD. We are proposing here, a pilot double-blinded, randomized controlled trial to examine the tolerability and early efficacy of minocycline in adults with SCD at two dosing regimens (200 mg and 300 mg daily) versus placebo over one year. Participants will undergo a neuropsychological exam using the NIH Toolbox Cognition Battery at both study enrollment and exit (after one year) to assess for changes/stability of cognition. Participants will receive monthly phone calls/text messages to assess for adverse events and will be seen every three months for pill counts and routine laboratory monitoring. The primary outcome will be a comparison of adverse events across the two dosing strategies versus placebo. Early evidence for cognitive benefit will also be assessed from the results of the NIH Toolbox.

Start Date01 Jun 2025

Sponsor / Collaborator

University of Cincinnati (Ohio)

100 Clinical Results associated with Minocycline Hydrochloride

100 Translational Medicine associated with Minocycline Hydrochloride

100 Patents (Medical) associated with Minocycline Hydrochloride

11,027

Literatures (Medical) associated with Minocycline Hydrochloride

24 Mar 2025·Journal of biomolecular structure & dynamics

Inhibition of respiratory syncytial virus by Daclatasvir and its derivatives: synthesis of computational derivatives as a new drug development

Article

Author: Abdalla, Mohnad ; Mitra, Debanjan ; Afreen, Shagufta ; Das Mohapatra, Pradeep K.

The most common cause of respiratory tract illness in newborns and young children is the respiratory syncytial virus (RSV). There is no approved vaccination or specific antiviral medication for RSV infections. Here, an attempt has been made to explore the potential of currently marketed drugs as well as their probable derivatives to improve the possibility of developing stronger medications against RSV. From the 100 synthetic drug compounds library, the best drug molecule was identified through drug-likeness properties, toxicity, molecular docking and molecular dynamics simulations. Molecular Mechanics Generalized Born Surface Area (MM-GBSA) was also a method that was applied in this study. Daclatasvir showed the highest binding energy and appeared as the best drug to inhibit matrix protein and a fusion protein of RSV. Based on Daclatasvir, 40 computational derivatives were made. D28, D34 and D40 showed far better results than the actual drug. Changes in lipophilicity character increase the binding energy of derivatives. Molecular dynamic simulations showed their non-deviated, non-fluctuated and stable complex formation with target proteins. The high number of amino acid contacts throughout the trajectory increases the stability and effectiveness of derivatives. The key to producing a novel medicine to eradicate RSV is provided by derivatives. Daclatasvir will be employed as a potential RSV inhibitor up until that point.

01 Mar 2025·JOURNAL OF COLLOID AND INTERFACE SCIENCE

Probing antimicrobial synergy by novel lipopeptides paired with antibiotics

Article

Author: Campana, Mario ; Ge, Tianhao ; Shen, Kangcheng ; Liao, Mingrui ; Hu, Xuzhi ; McBain, Andrew J ; Wu, Chunxian ; Gong, Haoning ; Lu, Jian R

Antimicrobial resistance (AMR) is fast becoming a major global challenge in both hospital and community settings as many current antibiotics and treatment processes are under the threat of being rendered less effective or ineffective. Synergistic combination of an antibiotic and an aiding agent with a different set of properties provides an important but largely unexploited option to 'repurpose' existing biomaterial's space while addressing issues of potency, spectrum, toxicity and resistance in early stages of antimicrobial drug discovery. This work explores how to combine tetracycline/minocycline (TC/MC) with a broad-spectrum antimicrobial lipopeptide that has been designed to improve the efficiency of membrane targeting and intramembrane accumulation, thereby enhancing antimicrobial efficacy. Experimental measurements of fractional inhibition concentration index (FICI) were undertaken from binary antibiotic-lipopeptide combinations. Most FICI values were found to be lower than 0.5 against both Gram-positive and Gram-negative bacterial strains studied including 3 AMR strains, revealing strong synergetic effects via favorable membrane-lytic interactions. The antimicrobial actions of this type of binary combinations are featured by the fast time-killing and high TC/MC uptake, benefited from effective membrane-lytic disruptions by the lipopeptide. This study thus provides an important mechanistic understanding of the combined antibiotic-lipopeptide approach to improve the therapeutic potential of conventional antibiotics by illustrating how amphiphilic lipopeptide-antibiotic combinations interact with biological membranes, providing a promising alternative to combat AMR through rational design of lipopeptide as an aiding agent.

01 Mar 2025·FOOD CHEMISTRY

pH-regulated CQDs@Eu/GMP ICP sensor array and its fingerprinting on 96-well plates: Toward point-of-use/specific identification and quantitation of six tetracyclines in animal farm wastewater, milks and milk-derivative products

Article

Author: Li, Zhenghao ; Wang, Junxia ; Liu, Yu ; Wang, Xuedong ; Gao, Ming ; Bian, Chang ; Zhao, Yutao

Herein, a "lab-on-an-AIE@Ln/ICP" sensor array was constructed by employing aggregation-induced emission carbon quantum dots (AIE-CQDs) as the guest and Eu/GMP ICP as the host. Based on the antenna effect (AE) and reductive photo-induced electron transfer (r-PET) between CQDs@Eu/GMP ICPs and tetracyclines (TCs), the as-constructed sensor produced satisfactorily dual-emitting fluorescence. By combining pH regulation with principal component analysis (PCA), the underlying fingerprinting patterns realized the specific identification and quantitation of six TCs in animal farm wastewater, milks and milk-derivative products. Through the aggregation-induced quenching of CQDs@Eu/GMP ICPs on test strips, the discernible fluorescence alterations were successfully utilized for developing smartphone-based visual assay. To sum up, the prominent novelty of this study lies in that based on the comprehensive principles of AE and r-PET along with combination of pH-adjustment and PCA, the pioneered sensor assay achieves specifically identifying and sensing individual TCs for their rapid and on-site detection in animal-derived matrices.

News (Medical) associated with Minocycline Hydrochloride

05 Mar 2025

·ir.journeymedicalcorp.com

Journey Medical Corporation Announces Publication in the Journal of the American Medical Association - Dermatology of the Phase 3 Clinical Trial Results of Emrosi™ (DFD-29) to Treat Rosacea

DFD-29 (40 mg Minocycline Hydrochloride Modified-Release Capsules, 10 mg immediate release and 30 mg extended release) achieved the co-primary and all secondary endpoints with no significant safety issues when administered once daily for 16 weeks Published data from two Phase 3 clinical trials demonstrated statistical superiority of DFD-29 over both Oracea® (doxycycline) capsules and placebo for IGA treatment success and the reduction of total lesion count, as well as significantly superior reduction in erythema compared to placebo in both studies U.S. FDA approved Emrosi™ (also known as DFD-29) for the treatment of inflammatory lesions of rosacea in adults in November 2024; launch expected in early spring of 2025 SCOTTSDALE, Ariz., March 05, 2025 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”), a commercial-stage pharmaceutical company that primarily focuses on selling and marketing U.S. Food and Drug Administration (“FDA”)-approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced that full results from two Phase 3 multicenter, randomized, double-blind, parallel-group, active-comparator and placebo-controlled clinical trials, Minocycline Versus Oracea® in Rosacea-1 (“MVOR-1”) and Minocycline Versus Oracea in Rosacea-2 (“MVOR-2”), evaluating Minocycline Hydrochloride Extended Release Capsules, 40 mg (“DFD-29” or “Emrosi”) for the treatment of moderate-to-severe papulopustular rosacea in adults were published in the Journal of the American Medical Association - Dermatology (“JAMA Dermatology”). The results demonstrated the efficacy, safety and tolerability of oral DFD-29 in rosacea. Read the full publication here: JAMA. The FDA approved Emrosi™ for the treatment of inflammatory lesions of rosacea in adults in November 2024. Claude Maraoui, Co-Founder, President and Chief Executive Officer of Journey Medical, stated, “Emrosi’s FDA approval last November, supported by these robust and clinically meaningful outcomes, positions it as a potential new treatment paradigm for millions of patients with rosacea. We are thrilled that the positive results of our two Phase 3 clinical trials were published in JAMA Dermatology. This milestone underscores the significance of these findings and reinforces Emrosi’s potential to meaningfully benefit patients when we launch, which we expect will be in early spring.” Subjects in the MVOR-1 and MVOR-2 Phase 3 clinical trials were randomized in a 3:3:2 ratio to treatment with DFD-29, Oracea or placebo once daily for 16 weeks. The primary objective of both studies was to evaluate the safety and efficacy of DFD-29 compared to placebo for the treatment of papulopustular rosacea. The secondary objective was to evaluate the safety and efficacy of DFD-29 compared to Oracea. Both clinical trials achieved the co-primary and all secondary endpoints, which compared the efficacy of DFD-29 to Oracea and placebo for the treatment of rosacea. The proportion of subjects achieving Investigator’s Global Assessment (“IGA”) treatment success in the DFD-29 group was statistically superior to those in Oracea and placebo groups, as well as the reduction in the total inflammatory lesion count from baseline to Week 16. On a secondary endpoint related to erythema (redness) assessment, DFD-29 showed significantly superior reduction in Clinician’s Erythema Assessment (“CEA”) compared to placebo in both clinical trials. There were no major safety issues or serious adverse events related to study products in both MVOR-1 and MVOR-2 trials. The number of treatment emergent adverse events (“TEAEs”) and their severity were similar between the treatment groups. The number of TEAEs related to study products were also similar between the groups. MVOR-1 Results In the DFD-29 group, 65.0% of subjects demonstrated IGA success, while 46.1% showed IGA success in the Oracea group and 31.2% of subjects showed IGA success in the placebo group. The difference between the DFD-29 and Oracea groups was statistically significant with a p-value of 0.01, and the difference between the DFD-29 and the placebo groups was statistically significant with a p-value of <0.001. The DFD-29 group showed a mean reduction of 21.3 lesions, while the Oracea group showed a mean reduction of 15.8 lesions, and the placebo group showed a mean reduction of 12.1 lesions from baseline to week 16. The difference between the DFD-29 and Oracea groups and the difference between the DFD-29 and placebo groups were statistically significant, each with a p-value of <0.001. Additionally, at Week 16, a significantly greater percentage of participants on DFD-29 experienced at least a 2-grade reduction from baseline in CEA score versus placebo (31.7% vs 13.8%; p-value of 0.006). MVOR-2 Results In the DFD-29 group, 60.1% of subjects demonstrated IGA success, while 31.4% showed IGA success in the Oracea group and 26.8% of subjects showed IGA success in the placebo group. The difference between the DFD-29 and Oracea groups was statistically significant with a p-value of <0.001, and the difference between the DFD-29 and the placebo groups was statistically significant with a p-value of <0.001. The DFD-29 group showed a mean reduction of 18.0 lesions, while the Oracea group showed a mean reduction of 14.9 lesions, and the placebo group showed a mean reduction of 11.1 lesions from baseline to week 16. The difference between the DFD-29 and Oracea groups and the difference between the DFD-29 and placebo groups were statistically significant, each with a p-value of <0.001. Additionally, at Week 16, a significantly greater percentage of participants on DFD-29 experienced at least a 2-grade reduction from baseline in CEA score versus placebo (24.5% vs 12.0%; p-value of 0.02). Summary of Co-Primary Endpoint Results from MVOR-1 and MVOR-2 Important Safety Information Indication: EMROSI™ is indicated for the treatment of inflammatory lesions (papules and pustules) of rosacea in adults. Adverse Events: The most common adverse reaction reported by ≥1% of subjects treated with EMROSI and more frequently than in subjects receiving placebo was dyspepsia. Contraindications: EMROSI should not be taken by patients who have a history of hypersensitivity to any of the tetracyclines. Warnings/Precautions: Cases of anaphylaxis, serious skin reactions (e.g., Stevens-Johnson syndrome), erythema multiforme, and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been reported postmarketing with minocycline use in patients with acne. If DRESS syndrome is recognized, discontinue EMROSI immediately. Use during the second and third trimesters of pregnancy, infancy and childhood up to the age of 8 years may cause permanent discoloration of the teeth and reversible inhibition of bone growth. Discontinue EMROSI use if Antibiotic-Associated Colitis occurs. Discontinue EMROSI if liver injury is suspected. Patients experiencing light-headedness, dizziness or vertigo should be cautioned about driving vehicles or operating heavy machinery. Clinical manifestations include headache, blurred vision, diplopia, and vision loss. Discontinue EMROSI immediately if symptoms occur. Symptoms may be manifested by fever, rash, arthralgia, and malaise. Discontinue EMROSI immediately if symptoms occur. Patients should minimize or avoid exposure to natural or artificial sunlight while using EMROSI. Tetracycline-class antibiotics are known to cause hyperpigmentation. EMROSI may induce hyperpigmentation in many organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity, sclerae and heart valves. Because of the potential for drug-resistant bacteria to develop during the use of EMROSI, use EMROSI only as indicated. If superinfection occurs, discontinue EMROSI and institute appropriate therapy. Perform periodic laboratory evaluations of organ systems, including hematopoietic, renal and hepatic studies. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. For full prescribing information, please visit www.emrosi.com. About RosaceaRosacea is a chronic, relapsing, inflammatory skin condition that most commonly presents with symptoms such as deep facial redness, acne-like inflammatory lesions (papules and pustules) and spider veins (telangiectasia). According to The National Rosacea Society, it is estimated that rosacea affects over 16 million Americans and as many as 415 million people worldwide. Rosacea is most frequently seen in adults between 30 and 50 years of age. Surveys conducted by The National Rosacea Society report that more than 90 percent of rosacea patients said their condition had lowered their self-confidence and self-esteem, and 41 percent stated that it had caused them to avoid public contact or cancel social engagements. Among rosacea patients with severe symptoms, 88 percent said the disorder had adversely affected their professional interactions, and 51 percent said they had missed work because of their condition. About Journey Medical CorporationJourney Medical Corporation (Nasdaq: DERM) (“Journey Medical”) is a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of FDA-approved prescription pharmaceutical products for the treatment of dermatological conditions through its efficient sales and marketing model. The Company currently markets seven branded and two generic products that help treat and heal common skin conditions. The Journey Medical team comprises industry experts with extensive experience in developing and commercializing some of dermatology’s most successful prescription brands. Journey Medical is located in Scottsdale, Arizona and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). Journey Medical’s common stock is registered under the Securities Exchange Act of 1934, as amended, and it files periodic reports with the U.S. Securities and Exchange Commission (“SEC”). For additional information about Journey Medical, visit www.journeymedicalcorp.com. Forward-Looking StatementsThis press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. As used below and throughout this press release, the words “the Company”, “we”, “us” and “our” may refer to Journey Medical. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. The words “anticipate,” “believe,” “estimate,” “may,” “expect,” “will,” “could,” “project,” “intend,” “potential” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated include: the fact that our products and product candidates are subject to time and cost intensive regulation and clinical testing and as a result, may never be successfully developed or commercialized; a substantial portion of our sales derive from products that are without patent protection and/or are, or may become, subject to third-party generic competition, the introduction of new competitor products, or an increase in market share of existing competitor products, any of which could have a significant adverse impact on our operating income; we operate in a heavily regulated industry, and we cannot predict the impact that any future legislation or administrative or executive action may have on our operations; our revenue is dependent mainly upon sales of our dermatology products and any setback relating to the sale of such products could impair our operating results; competition could limit our products’ commercial opportunity and profitability, including competition from manufacturers of generic versions of our products; the risk that our products do not achieve broad market acceptance, including by government and third-party payors; our reliance on third parties for several aspects of our operations; our dependence on our ability to identify, develop, and acquire or in-license products and integrate them into our operations, at which we may be unsuccessful; the dependence of the success of our business, including our ability to finance our company and generate additional revenue, on the successful commercialization Emrosi™ and the successful development, regulatory approval and commercialization of any future product candidates that we may develop, in-license or acquire; clinical drug development is very expensive, time consuming, and uncertain and any clinical trials we may initiate for future product candidates may fail to adequately demonstrate the safety and efficacy of our current or any future product candidates; our competitors could develop and commercialize products similar or identical to ours; risks related to the protection of our intellectual property and our potential inability to maintain sufficient patent protection for our technology and products; our business and operations would suffer in the event of computer system failures, cyber-attacks, or deficiencies in our or our third parties’ cybersecurity; the effects of major public health issues, epidemics or pandemics on our product revenues and any future clinical trials; our potential need to raise additional capital; the substantial doubt expressed about our ability to continue as a going concern; Fortress controls a voting majority of our common stock, which could be detrimental to our other stockholders; as well as other risks described in Part I, Item 1A, “Risk Factors,” in our Annual Report on Form 10-K for the year ended December 31, 2023, subsequent Reports on Form 10-Q, and our other filings we make with the SEC. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Company Contact:Jaclyn Jaffe (781) 652-4500ir@jmcderm.com Media Relations Contact:Tony Plohoros6 Degrees(908) 591-2839tplohoros@6degreespr.com Released March 5, 2025

Clinical ResultPhase 3Drug Approval

23 Jan 2025

·www.globenewswire.com

Journey Medical Corporation to Host Conference Call to Discuss U.S. Commercial Launch Plan for Emrosi™ (Minocycline Hydrochloride Extended Release Capsules, 40 mg) for the Treatment of Rosacea

Conference call and webcast scheduled to take place on Wednesday, February 5, 2025, at 4:30 p.m. E.T.SCOTTSDALE, Ariz., Jan. 23, 2025 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”), a commercial-stage pharmaceutical company that primarily focuses on selling and marketing U.S. Food and Drug Administration (“FDA”)-approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced that its management team will host a conference call to provide an update on the commercial launch plan for Emrosi™ (Minocycline Hydrochloride Extended Release Capsules, 40 mg), formerly referred to as DFD-29. The FDA approved Emrosi for the treatment of inflammatory lesions of rosacea in adults in November of 2024. Emrosi was developed in collaboration with Dr. Reddy’s Laboratories Ltd. Claude Maraoui, Co-Founder, President, and Chief Executive Officer of Journey Medical, said, “We are excited to provide an update on the upcoming launch of Emrosi, including progress on our pre-commercial activities, launch timing and our commercial plans. We are completing the manufacturing of Emrosi launch quantities for the U.S. market, and our seasoned dermatology-focused sales force is preparing for a successful roll out of the product. In line with the approved label, we intend to execute a launch strategy to drive Emrosi toward becoming a new oral standard of care for adult rosacea patients.” Conference Call and Webcast InformationJourney Medical management will conduct a conference call and webcast to provide an update on the commercial launch plan for Emrosi on February 5, 2025, at 4:30 p.m. ET. To listen to the conference call, interested parties within the U.S. should dial 1-866-777-2509 (domestic) or 1-412-317-5413 (international). All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into the Journey Medical conference call. Participants can register for the conference here: https://dpregister.com/sreg/10196252/fe5c1eeee0. Please note that registered participants will receive their dial-in number upon registration. A live webcast can be accessed on the News and Events page of the Investors section of Journey Medical’s website, www.journeymedicalcorp.com, and will remain available for replay for approximately 30 days after the meeting. Important Safety Information Indication: EMROSI™ is indicated for the treatment of inflammatory lesions (papules and pustules) of rosacea in adults. Adverse Events: The most common adverse reaction reported by ≥1% of subjects treated with EMROSI and more frequently than in subjects receiving placebo was dyspepsia. Contraindications: EMROSI should not be taken by patients who have a history of hypersensitivity to any of the tetracyclines. Warnings/Precautions: Cases of anaphylaxis, serious skin reactions (e.g., Stevens-Johnson syndrome), erythema multiforme, and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been reported postmarketing with minocycline use in patients with acne. If DRESS syndrome is recognized, discontinue EMROSI immediately. Use during the second and third trimesters of pregnancy, infancy and childhood up to the age of 8 years may cause permanent discoloration of the teeth and reversible inhibition of bone growth. Discontinue EMROSI use if Antibiotic-Associated Colitis occurs. Discontinue EMROSI if liver injury is suspected. Patients experiencing light-headedness, dizziness or vertigo should be cautioned about driving vehicles or operating heavy machinery. Clinical manifestations include headache, blurred vision, diplopia, and vision loss. Discontinue EMROSI immediately if symptoms occur. Symptoms may be manifested by fever, rash, arthralgia, and malaise. Discontinue EMROSI immediately if symptoms occur. Patients should minimize or avoid exposure to natural or artificial sunlight while using EMROSI. Tetracycline-class antibiotics are known to cause hyperpigmentation. EMROSI may induce hyperpigmentation in many organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity, sclerae and heart valves. Because of the potential for drug-resistant bacteria to develop during the use of EMROSI, use EMROSI only as indicated. If superinfection occurs, discontinue EMROSI and institute appropriate therapy. Perform periodic laboratory evaluations of organ systems, including hematopoietic, renal and hepatic studies. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. For full prescribing information, please visit www.emrosi.com. About RosaceaRosacea is a chronic, relapsing, inflammatory skin condition that most commonly presents with symptoms such as deep facial redness, acne-like inflammatory lesions (papules and pustules) and spider veins (telangiectasia). According to The National Rosacea Society, it is estimated that rosacea affects over 16 million Americans and as many as 415 million people worldwide. Rosacea is most frequently seen in adults between 30 and 50 years of age. Surveys conducted by The National Rosacea Society report that more than 90 percent of rosacea patients said their condition had lowered their self-confidence and self-esteem, and 41 percent stated that it had caused them to avoid public contact or cancel social engagements. Among rosacea patients with severe symptoms, 88 percent said the disorder had adversely affected their professional interactions, and 51 percent said they had missed work because of their condition. About Journey Medical CorporationJourney Medical Corporation (Nasdaq: DERM) (“Journey Medical”) is a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of FDA-approved prescription pharmaceutical products for the treatment of dermatological conditions through its efficient sales and marketing model. The Company currently markets seven branded and two generic products that help treat and heal common skin conditions. The Journey Medical team comprises industry experts with extensive experience in developing and commercializing some of dermatology’s most successful prescription brands. Journey Medical is located in Scottsdale, Arizona and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). Journey Medical’s common stock is registered under the Securities Exchange Act of 1934, as amended, and it files periodic reports with the U.S. Securities and Exchange Commission (“SEC”). For additional information about Journey Medical, visit www.journeymedicalcorp.com. Forward-Looking StatementsThis press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. As used below and throughout this press release, the words “the Company”, “we”, “us” and “our” may refer to Journey Medical. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. The words “anticipate,” “believe,” “estimate,” “may,” “expect,” “will,” “could,” “project,” “intend,” “potential” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated include: the fact that our products and product candidates are subject to time and cost intensive regulation and clinical testing and as a result, may never be successfully developed or commercialized; a substantial portion of our sales derive from products that may become subject to third-party generic competition, the introduction of new competitor products, or an increase in market share of existing competitor products, any of which could have a significant adverse impact on our operating income; we operate in a heavily regulated industry, and we cannot predict the impact that any future legislation or administrative or executive action may have on our operations; our revenue is dependent mainly upon sales of our dermatology products and any setback relating to the sale of such products could impair our operating results; competition could limit our products’ commercial opportunity and profitability, including competition from manufacturers of generic versions of our products; the risk that our products do not achieve broad market acceptance, including by government and third-party payors; our reliance third parties for several aspects of our operations; our dependence on our ability to identify, develop, and acquire or in-license products and integrate them into our operations, at which we may be unsuccessful; the dependence of the success of our business, including our ability to finance our company and generate additional revenue, on the successful commercialization of our recently approved product, EmrosiTM, and any future product candidates that we may develop, in-license or acquire; clinical drug development is very expensive, time consuming, and uncertain and our clinical trials may fail to adequately demonstrate the safety and efficacy of our current or any future product candidates; our competitors could develop and commercialize products similar or identical to ours; risks related to the protection of our intellectual property and our potential inability to maintain sufficient patent protection for our technology and products; our business and operations would suffer in the event of computer system failures, cyber-attacks, or deficiencies in our or our third parties’ cybersecurity; the substantial doubt about our ability to continue as a going concern; the effects of major public health issues, epidemics or pandemics on our product revenues and any future clinical trials; our potential need to raise additional capital; Fortress controls a voting majority of our common stock, which could be detrimental to our other shareholders; as well as other risks described in Part I, Item 1A, “Risk Factors,” in our Annual Report on Form 10-K for the year ended December 31, 2023, subsequent Reports on Form 10-Q, and our other filings we make with the SEC. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Company Contact:Jaclyn Jaffe (781) 652-4500ir@jmcderm.com Media Relations Contact:Tony Plohoros6 Degrees(908) 591-2839tplohoros@6degreespr.com

Drug Approval

07 Jan 2025

·www.globenewswire.com

Fortress Biotech and Cyprium Therapeutics Announce U.S. FDA Acceptance and Priority Review of NDA for CUTX-101 for Treatment of Menkes Disease

Priority review granted for CUTX-101 with PDUFA target action date set for June 30, 2025 Cyprium is eligible to receive royalties and up to $129 million in aggregate development and sales milestones Cyprium also retains ownership over any Priority Review Voucher that may be issued at NDA approval Jan. 06, 2025 -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) and its majority-owned subsidiary, Cyprium Therapeutics, Inc. (“Cyprium”), today announced the acceptance for review of the New Drug Application (“NDA”) by the U.S. Food and Drug Administration (“FDA”) for CUTX-101 (Copper Histidinate) for the treatment of Menkes disease, a rare X-linked recessive pediatric disease caused by gene mutations of the copper transporter ATP7A. The NDA has been granted Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 30, 2025. In December 2023, Sentynl Therapeutics, Inc. (“Sentynl”), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences, Ltd. (“Zydus Group”), assumed full responsibility for the development and commercialization of CUTX-101 from Cyprium. The NDA submission was completed by Sentynl who will be responsible for commercialization upon approval. As described below, Cyprium is eligible to receive royalties and retains ownership of any Priority Review Voucher that may be issued. The CUTX-101 NDA submission is supported by positive topline clinical efficacy results for CUTX-101, demonstrating statistically significant improvement in overall survival for Menkes disease subjects who received early treatment with CUTX-101, with a nearly 80% reduction in the risk of death compared to an untreated historical control cohort. Median overall survival was 177.1 months for CUTX-101 early treatment cohort compared to 16.1 months for the untreated historical control cohort. CUTX-101 was previously granted FDA Breakthrough Therapy, Fast Track, Rare Pediatric Disease and Orphan Drug Designations. Additionally, the European Medicines Agency previously granted Orphan Drug Designation for CUTX-101. “We are thrilled that the NDA for CUTX-101 for the treatment of Menkes disease was accepted for review by the FDA and look forward to working with our partner, Sentynl, and the FDA during its review period. CUTX-101 could be the first FDA-approved treatment for Menkes disease, making this submission an important milestone for our company and for the patients suffering from this rare, often fatal, pediatric disease,” said Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer and Cyprium’s Chairman. “Our late-stage portfolio continues to advance with two recent FDA approvals received in Q4 of 2024 for Emrosi™ and Unloxcyt™ and this acceptance and Priority Review for the CUTX-101 NDA. We look forward to the potential achievement of additional upcoming milestones across our extensive portfolio of commercial and clinical-stage assets.” “Menkes disease presents a difficult journey for patients and their caregivers, as ATP7A mutations impact the transport of copper to a range of organs and systems, such as the lungs, brain and heart. With no known cure or current FDA-approved treatments, death typically occurs between 2 to 3 years of age,” said Matt Heck, President & Chief Executive Officer of Sentynl. “We are eager for the FDA to review our application for CUTX-101, which has the potential to be the first FDA-approved therapy for this devastating condition.” If the CUTX-101 NDA is approved, the product may be eligible for a Rare Pediatric Disease Priority Review Voucher (PRV), for which Cyprium would retain ownership, and which can be redeemed for a subsequent marketing application or sold or transferred to a third party. Cyprium is also eligible to receive royalties and up to $129 million in aggregate development and sales milestones from Sentynl. CUTX-101 is an investigational drug currently under NDA review by the FDA to treat patients with Menkes disease. CUTX-101 is a subcutaneous injectable formulation of copper histidinate manufactured under current good manufacturing practice (“cGMP”) that is intended to improve tolerability due to its physiological pH. In a Phase 1/2 clinical trial conducted by Stephen G. Kaler, M.D., M.P.H., at the National Institutes of Health (“NIH”), early treatment of patients with Menkes disease with CUTX-101 led to an improvement in neurodevelopmental outcomes and survival. CUTX-101 has been granted FDA Breakthrough Therapy, Fast Track, Rare Pediatric Disease and FDA Orphan Drug Designations. Additionally, the European Medicines Agency granted Orphan Designation for CUTX-101. An expanded access protocol for patients with Menkes disease is ongoing at multiple U.S. medical centers. Menkes disease is a rare X-linked recessive pediatric disease caused by gene mutations of the copper transporter ATP7A. The minimum birth prevalence for Menkes disease is believed to be 1 in 34,810 live male births, and potentially as high as 1 in 8,664 live male births, based on recent genome-based ascertainment (Kaler SG, Ferreira CR, Yam LS. Estimated birth prevalence of Menkes disease and ATP7A-related disorders based on the Genome Aggregation Database (gnomAD). Molecular Genetics and Metabolism Reports 2020 June 5;24:100602). The condition is characterized by distinctive clinical features, including sparse and depigmented hair (“kinky hair”), connective tissue problems, and severe neurological symptoms such as seizures, hypotonia, failure to thrive, and neurodevelopmental delays. Mortality is high in untreated Menkes disease, with many patients dying between 2-3 years of age. Milder versions of ATP7A mutations are associated with other conditions, including Occipital Horn Syndrome and ATP7A-related Distal Motor Neuropathy. Currently, there is no FDA-approved treatment for Menkes disease and its variants. Cyprium Therapeutics, Inc. (“Cyprium”) is focused on the development of novel therapies for the treatment of Menkes disease and related copper metabolism disorders. In March 2017, Cyprium entered into a Cooperative Research and Development Agreement with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (“NICHD”), part of the NIH, to advance the clinical development of CUTX-101 (Copper Histidinate injection) for the treatment of Menkes disease. CUTX-101 is an investigational drug currently under NDA review by the FDA to treat patients with Menkes disease. In 2023, Cyprium completed the transfer of its proprietary rights and assigned its FDA documents pertaining to CUTX-101 to Sentynl Therapeutics, Inc. Cyprium and NICHD also have an ongoing worldwide, exclusive license agreement to develop and commercialize adeno-associated virus (AAV)-based gene therapy, called AAV-ATP7A, to deliver working copies of the copper transporter that is defective in patients with Menkes disease, and to be used in combination with CUTX-101; AAV-ATP7A gene therapy is currently in pre-clinical development and has received FDA Orphan Drug Designation. Cyprium was founded by, and is a majority-owned subsidiary of, Fortress Biotech, Inc. (Nasdaq: FBIO). For more information, visit www.cypriumtx.com. Fortress Biotech, Inc. (“Fortress”) is an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue. The company has seven marketed prescription pharmaceutical products and over 20 programs in development at Fortress, at its majority-owned and majority-controlled partners and subsidiaries and at partners and subsidiaries it founded and in which it holds significant minority ownership positions. Such product candidates span six large-market areas, including oncology, rare diseases and gene therapy, which allow it to create value for shareholders. Fortress advances its diversified pipeline through a streamlined operating structure that fosters efficient drug development. The Fortress model is focused on leveraging its significant biopharmaceutical industry expertise and network to further expand the company’s portfolio of product opportunities. Fortress has established partnerships with some of the world’s leading academic research institutions and biopharmaceutical companies to maximize each opportunity to its full potential, including AstraZeneca, City of Hope, Fred Hutchinson Cancer Center, Nationwide Children’s Hospital and Sentynl. For more information, visit www.fortressbiotech.com. Sentynl Therapeutics, Inc. (“Sentynl”) is a U.S.-based biopharmaceutical company focused on bringing innovative therapies to patients suffering from rare diseases. The company was acquired by the Zydus Group in 2017. Sentynl’s experienced management team has previously built multiple successful pharmaceutical companies. With a focus on commercialization, Sentynl looks to source effective and well-differentiated products across a broad spectrum of therapeutic areas to address unmet needs. Sentynl is committed to the highest ethical standards and compliance with all applicable laws, regulations and industry guidelines. For more information, visit https://sentynl.com. Zydus Lifesciences Ltd. with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs over 27,000 people worldwide, including 1,400 scientists engaged in R & D, and is driven by its mission to unlock new possibilities in lifesciences through quality healthcare solutions that impact lives. The group aspires to transform lives through path-breaking discoveries. For more information, visit https://www.zyduslife.com/zyduslife. The content above comes from the network. if any infringement, please contact us to modify.

Orphan DrugBreakthrough TherapyNDAPriority ReviewLicense out/in

100 Deals associated with Minocycline Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D00850	Minocycline Hydrochloride	J01AA08 A01AB23	DB01017

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Rosacea	United States	Journey Medical Corp.	28 May 2020
Acne Vulgaris	United States	Bausch Health US LLC	08 May 2006
Anthrax	Japan	Pfizer Japan, Inc.	06 Mar 2002
Infectious Diseases	China	Haikou Pharmaceutical Factory Co., Ltd	01 Jan 1992
Typhus, Endemic Flea-Borne	Japan	Pfizer Japan, Inc.	01 Sep 1989
Psittacosis	Japan	Pfizer Japan, Inc.	05 Nov 1985
Acute Bronchitis	Japan	Pfizer Japan, Inc.	20 Apr 1979
Bacterial Vaginosis	Japan	Pfizer Japan, Inc.	20 Apr 1979
Cystitis	Japan	Pfizer Japan, Inc.	20 Apr 1979
Dacryocystitis	Japan	Pfizer Japan, Inc.	20 Apr 1979
Epididymitis	Japan	Pfizer Japan, Inc.	20 Apr 1979
Gonorrhea	Japan	Pfizer Japan, Inc.	20 Apr 1979
Hordeolum	Japan	Pfizer Japan, Inc.	20 Apr 1979
Infectious enteritis	Japan	Pfizer Japan, Inc.	20 Apr 1979
Intrauterine infection	Japan	Pfizer Japan, Inc.	20 Apr 1979
Jaw inflammation	Japan	Pfizer Japan, Inc.	20 Apr 1979
Laryngitis	Japan	Pfizer Japan, Inc.	20 Apr 1979
Lung Abscess	Japan	Pfizer Japan, Inc.	20 Apr 1979
Lymphadenitis	Japan	Pfizer Japan, Inc.	20 Apr 1979
Mastitis	Japan	Pfizer Japan, Inc.	20 Apr 1979

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Peri-Implantitis	Phase 3	United States	OraPharma, Inc.	01 Apr 2012
Peri-Implantitis	Phase 3	Germany	OraPharma, Inc.	01 Apr 2012
Peri-Implantitis	Phase 3	Sweden	OraPharma, Inc.	01 Apr 2012
Peri-Implantitis	Phase 3	United Kingdom	OraPharma, Inc.	01 Apr 2012
Chronic Periodontitis	Phase 3	United States	Sunstar Americas, Inc.	01 Jan 2006
Aggressive Periodontitis	Phase 3	United States	OraPharma, Inc.	01 Jan 2004
Impetigo	Phase 2	Israel	VYNE Pharmaceuticals Ltd.	01 Aug 2010
Amyotrophic Lateral Sclerosis	Phase 2	United States	Pfizer Inc.	01 Jul 2006
Acute Kidney Injury	Phase 1	Germany	Rempex Pharmaceuticals, Inc.	29 May 2017
Allergic skin reaction	Phase 1	-	VYNE Therapeutics, Inc.	21 Sep 2016

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02203552 (CTgov)	Phase 2	Breast cancer recurrent \| Depressive Disorder \| Neutropenia ... View more	56	laboratory biomarker analysis+minocycline hydrochloride (Arm I (Minocycline Hydrochloride))	kanqdngwhd(dxtbufwdsz) = nypsxlfasu lavwbhlfbu (bmridmnfus, bbsptdsgyg - npktvqdfsi) View more	-	08 Jan 2025
				placebo (Arm II (Placebo))	kanqdngwhd(dxtbufwdsz) = owzrlolacv lavwbhlfbu (bmridmnfus, yrzyiypifj - ddeigphyjk) View more
CTR20211291 (NEWS) Manual	Phase 3	Acne Vulgaris	-	外用4%米诺环素泡沫剂	bqqwzcafli(ficutdvobo): P-Value = <0.001 Met View more	Positive	30 Jul 2024
				Placebo
NCT01283997 (CTgov)	Phase 2	Multiple Myeloma	79	Placebo (Placebo Group)	scccvpysha(slajhsptwb) = uakucvbazv diwtgodemh (rhwnkkrxbc, 0.25) View more	-	13 Jun 2024
				Minocycline (Minocycline Group)	scccvpysha(slajhsptwb) = rzeyvoljsf diwtgodemh (rhwnkkrxbc, 0.28) View more
NCT03762915 (CTgov)	Phase 4	Inflammation	70	minocycline HCl microspheres (SRP With Minocycline HCl Microspheres)	tjmaxmckuc(ujrythqeof) = exftwlypba vimhhokxxx (dnfetlohwe, reuojoiaij - pewqkkfwla) View more	-	25 Mar 2024
				minocycline HCl (SRP Without Minocycline HCl Microspheres)	tjmaxmckuc(ujrythqeof) = iyukpueqbo vimhhokxxx (dnfetlohwe, dlnffpzawr - frvcsskwin) View more
NCT02564978 (CTgov)	Phase 2	dry age-related macular degeneration \| Age Related Macular Degeneration \| Geographic Atrophy	37	Minocycline	kkhufvbdht(cvrsvlmnps) = iamkdqrlcl kdyefypwet (kszktpluus, 0.03) View more	-	01 Feb 2024
NCT03320018 (H2M, CTgov)	Phase 2/3	Acute Ischemic Stroke	15	Hydrogen+minocycline (Hydrogen/Minocycline)	ttlfiditnf = bbhbldrjxf rjrymwpitp (edantunxuy, gcodwqwptj - lnqbteuwkp) View more	-	19 Dec 2023
				Placebo Hydrogen (Placebo Hydrogen/Placebo Minocycline)	ttlfiditnf = cugoqnobxu rjrymwpitp (edantunxuy, nscorcqsrh - lgynvaojmg) View more
ASCO 12023 \| ASCO 22023 Manual	Not Applicable	Squamous non-small cell lung cancer First line	45	Tislelizumab+Carboplatin+pm-Pac	lwogosryjw(evwnaqptim) = The most common TRAE were alopecia (91.1%), leukopenia (80%), peripheral neurosensory numbness (55.6%) and extremity pain (24.4%). The most common grade 3 or higher AE was neutropenia (33.3%), which is commonly associated with chemotherapy. hlhjznemuo (dldariewui )	Positive	31 May 2023
				Tislelizumab+Carboplatin+pm-Pac (PD-L1 expression＜1%)
ATS2023	Not Applicable	-	-	Minocycline	tcpxsfgfjx(vecgcdofee) = Our patient manifested with minocycline-induced pleuropericarditis. Stopping the drug and initiating steroid therapy resulted in prompt clinical improvement. This case illustrates that minocycline, despite its mild toxicity profile, can give rise to serious adverse effects and should be considered in patients on this medication who present with pleuropericarditis. aaptuhffby (qduwvbjuhs )	-	21 May 2023
NCT02802631 (CTgov)	Phase 1	-	69	Minocin (minocycline) (Cohort 1)	dgglfgnfyj = wkmugxdncc bsukzlemkl (ylqbuehajs, arsuiesnqh - szrkcmnwtj) View more	-	09 May 2023
				Minocin (minocycline) (Cohort 2)	dgglfgnfyj = nkvqgbkwwl bsukzlemkl (ylqbuehajs, vumlnpuaee - ucxkeufhuh) View more
NCT02055963 (CTgov)	Phase 2	Head and Neck Neoplasms	30	Questionnaires+minocycline (Minocycline)	qiivlfbgwk(epzqjcbhox) = djebmwffql tyjrfkpbxj (rshyqjrikz, 32.4) View more	-	18 Oct 2022
				Questionnaires (Placebo)	qiivlfbgwk(epzqjcbhox) = usosnkyfun tyjrfkpbxj (rshyqjrikz, 38.2) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis