To compare the efficacy of XDEMVY ophthalmic drop to its vehicle control for the treatment of Demodex blepharitis and its impact on the soft contact lens wearing experience.

开始日期2023-12-27

申办/合作机构

Tarsus Pharmaceuticals, Inc.

NCT06054217

/ Active, not recruiting临床2期

Evaluating the Effect of Two Dosing Regimens of an Exploratory Vehicle on Meibomian Gland Dysfunction in Patients With Demodex Lid Infestation

The purpose of this study is to evaluate and compare the effect of two dosing regimens, BID versus TID dosing, of an Exploratory Vehicle (EV) on meibomian gland dysfunction (MGD) in patients with Demodex lid infestation.

开始日期2023-08-01

申办/合作机构

Tarsus Pharmaceuticals, Inc.

NCT05838170

/ Completed临床2期

A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety, Tolerability, and Efficacy of TP-04 in Participants With Papulopustular Rosacea

This study is being done to evaluate the safety, tolerability, and efficacy of the study drug, TP-04, in participants with papulopustular rosacea (PPR).

开始日期2023-03-01

申办/合作机构

Tarsus Pharmaceuticals, Inc.

100 项与洛替拉纳相关的临床结果

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100 项与洛替拉纳相关的转化医学

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100 项与洛替拉纳相关的专利（医药）

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项与洛替拉纳相关的文献（医药）

2025-11-01·Parasite Epidemiology and Control

Efficacy of topical Ivermectin in controlling human Demodex infestation: Evidence from systematic review and meta-analysis

Article

作者: Paichitrojjana, Anon ; Khuancharee, Kitsarawut ; Paichitrojjana, Anand

Background:

Demodex mites are usually harmless but can contribute to inflammatory skin conditions like rosacea, blepharitis, and demodicosis. While new therapies like lotilaner, niclosamide, and berberine show promise against D. folliculorum, ivermectin remains widely used for its strong antiparasitic and anti-inflammatory effects. However, the direct effectiveness of ivermectin in reducing Demodex mite density in associated skin diseases is not fully quantified.

Materials and methods:

A systematic review and meta-analysis were conducted following PRISMA guidelines. PubMed, Scopus, the Cochrane Library, and Google Scholar were searched for studies published between December 2014 and December 2024. Eligible studies have assessed the effect of topical ivermectin on Demodex mite number or density using standardized diagnostic methods. Risk of bias was evaluated using the Risk of Bias Assessment Tool for Non-randomized Studies (RoBANS) and the Cochrane Risk of Bias Tool. Data were pooled using a random-effects model where appropriate.

Results:

A total of 2344 studies were identified, with five studies (n = 180 participants) meeting the inclusion criteria. All studies reported significant reductions in Demodex mite count or density after daily application of topical ivermectin 1 %. Meta-analyses demonstrated a mean reduction of 70.01 mites/cm² and an 80 % decrease in Demodex-positive (≥5 D/cm²) rates. A 16-week treatment duration was associated with a notable reduction, with effects sustained for up to 12 weeks post-treatment. Only mild, localized adverse events were reported, with no systemic side effects observed.

Conclusion:

Topical ivermectin is effective and well-tolerated for reducing the number and density of Demodex mites. A 16-week treatment course significantly decreases mite burden and improves clinical outcomes with minimal adverse events. However, the potential for mite repopulation after treatment underscores the importance of ongoing monitoring. Study heterogeneity and the limited number of included trials warrant cautious interpretation of the findings.

2025-09-01·Journal of Veterinary Research

A novel method for the determination of isoxazoline derivatives in plasma by ultra-high performance liquid chromatography–tandem mass spectrometry: validation and applicability to screening tests

Article

作者: Ziółkowski, Hubert ; Markowska-Buńka, Paulina ; Rasiński, Bartosz ; Jaroszewski, Jerzy J.

Abstract:

Introduction:

Isoxazoline derivatives such as fluralaner, sarolaner, lotilaner, and afoxolaner are a new class of insecticide and acaricide compounds. These compounds are characterised by rapid action and high efficacy over a period of up to several weeks. A method for identifying all four isoxazoline derivatives in animal and human plasma has not been proposed to date. Therefore, the aim of this study was to develop and validate a novel analytical method for the determination of fluralaner, sarolaner, lotilaner, and afoxolaner in laying hen plasma and to revalidate the proposed method in human, canine and feline plasma.

Material and Methods:

The plasma concentrations of isoxazoline derivatives were determined by ultra-high performance liquid chromatography–tandem mass spectrometry. Analytical samples were prepared by precipitating proteins with a mixture of 96% acetonitrile and 4% ammonium hydroxide (v/v). Chromatographic separation was achieved on a chromatographic column (1.8 μm 2.1 × 100 mm) using 0.1% formic acid in water and 0.1% formic acid in acetonitrile with gradient elution.

Results:

The results indicate that the described method is replicable, linear (r 2 = 0.99), precise (1.66% to 14.97%), accurate (1.19% to 11.67%), selective and sensitive (limit of quantitation = 1 ng/mL). Depending on the studied compound and animal species, total recovery reached 85–99%, and the matrix effect did not exceed 15% in any of the analyses.

Conclusion:

The proposed method is simple, effective, inexpensive and rapid because it requires only a single-step sample preparation protocol.

2025-09-01·Chinese Journal of Chromatography

Simultaneous identification and detection of four novel isoxazoline drugs in bovine-origin foods using ultra-high performance liquid chromatography coupled to quadrupole/linear ion trap mass spectrometry

Article

作者: Zhao, Fang ; Zhu, Wei-Xia ; Zhao, Wen-Jie ; Yang, Cheng ; Liu, Ya-Feng ; Hu, Kai ; Wei, Wei

Isoxazoline drugs （ISOs） are a class of five-membered heterocyclic compounds containing N and O atoms. They can inhibit γ-aminobutyric acid gated chloride channels and are widely used in the treatment of parasitic diseases in poultry. The intake of animal-derived foods by humans is an important way to come into contact with ISOs. Excessive use of ISOs can lead to their residues in animal-derived foods， thereby threatening human health and causing neurotoxicity and hepatotoxicity. To address the safety issues caused by ISO residues in animal-derived foods， an ultra-high performance liquid chromatography-quadrupole/linear ion trap mass spectrometry （UHPLC-Q/Trap MS） analytical method for four novel ISOs （fluralaner， sarolaner， afoxolaner， lotilaner） in bovine-origin foods （including milk， beef and bovine liver） was established. The sample was first extracted with acetonitrile and then purified with PRiME HLB solid phase extraction （SPE） column. Using 5 mmol/L ammonium acetate aqueous solution and acetonitrile as the mobile phase， after separation by Shim-pack GIST C18-AQ （100 mm×2.1 mm， 2.7 μm） chromatography column， the analysis was carried out in the multi-reaction monitoring （MRM） mode by information-dependent acquisition （IDA）， enhanced product ion scanning （EPI） and spectral library retrieval， and quantification was performed using the external standard method. The results showed that the four ISOs had good linear relationships within their respective mass concentration ranges. The correlation coefficients （r） were all ≥0.993 6， and the limits of detection （LODs） and quantification （LOQs） were 0.2-0.5 μg/kg and 0.5-1.0 μg/kg， respectively. Under the low， medium and high spiked levels （1， 2 and 10 μg/kg）， the recoveries of the four ISOs ranged from 67.6% to 118.9%， and the relative standard deviations （RSDs） ranged from 2.0% to 20.0%. In addition， in this study， qualitative screening and analysis of the target compounds were conducted through MRM-IDA-EPI combined with spectral library retrieval. Dual qualitative analysis of the target compounds was carried out based on information such as retention time and EPI fragment ions， which improved the accuracy of qualitative analysis and effectively eliminated the interference of false positive results. This method features low LODs and good recoveries. It is also simple and rapid to operate， with high sensitivity and accuracy. It can achieve qualitative and quantitative analysis of new ISOs residues in bovine-origin foods. This study can provide technical support for food safety agencies to implement preventive measures against new ISOs in animal foods.

142

项与洛替拉纳相关的新闻（医药）

2025-11-04

·ir.tarsusrx.com

Tarsus Reports Third Quarter 2025 Financial Results and Recent Business Achievements

« Back Nov 04, 2025 Delivered quarterly XDEMVY® net sales of approximately $119 million, up approximately 147% year-over-year Weekly multi-patient prescribers grew approximately 30% in the third quarter underscoring strong commercial momentum Management to host conference call today, November 4, 2025, at 1:30 p.m. PT / 4:30 p.m. ET IRVINE, Calif., Nov. 04, 2025 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), today announced financial results for the third quarter ended September 30, 2025. “Our third quarter results, highlighted by nearly $119 million in XDEMVY sales, reflect the strength of our commercial model, the scale of engagement across eye care, and the impact we’re having on patients,” said Bobak Azamian, M.D., Ph.D., Chief Executive Officer and Chairman of Tarsus. “We’ve established a new category in eye care, and XDEMVY is now one of the best-selling prescription eye drops. Simultaneously, we are expanding our pipeline with more category-creating programs like ocular rosacea – another widespread condition with significant unmet need – that position Tarsus for sustained, long-term growth. With each new milestone, we are deepening our impact and shaping the future of eye care.” Recent Business and Clinical Highlights Third Quarter 2025 Financial Results Year-to-Date 2025 Financial Results Conference Call and WebcastTarsus will host a conference call and webcast to discuss its third quarter 2025 financial results and business highlights today, November 4, 2025, at 1:30 p.m. PT / 4:30 p.m. ET. A live webcast will be available on the events section of the Tarsus website. A recorded version of the call will be available on the website shortly after the completion of the call and will be archived there for at least 90 days. About XDEMVY®XDEMVY (lotilaner ophthalmic solution) 0.25%, formerly known as TP-03, is a novel prescription eye drop designed to treat Demodex blepharitis by targeting and eradicating the root cause of the disease – Demodex mite infestation. XDEMVY was evaluated in two pivotal trials collectively involving more than 800 patients. Both trials met the primary endpoint and all secondary endpoints, with statistical significance and no serious treatment-related adverse events. Most patients found the XDEMVY eye drop to be neutral to very comfortable. The most common ocular adverse reactions observed in the studies were instillation site stinging and burning which was reported in 10% of patients. Other ocular adverse reactions reported by less than 2% of patients were chalazion/hordeolum (stye) and punctate keratitis. XDEMVY Indication and Important Safety Information INDICATIONS AND USAGEXDEMVY is indicated for the treatment of Demodex blepharitis. Most common side effects: The most common side effect in clinical trials was stinging and burning in 10% of patients. Other side effects in less than 2% of patients were chalazion/hordeolum and punctate keratitis. For additional information, please see full prescribing information available at https://xdemvy.com/. About TP-03TP-03 (lotilaner ophthalmic solution) 0.25% is a novel therapeutic designed to treat Demodex blepharitis by targeting and eradicating the root cause of disease – Demodex mite infestation. It was approved by the FDA in 2023 under the brand name XDEMVY® for the treatment of Demodex blepharitis. Lotilaner is a well-characterized anti-parasitic agent that paralyzes and eradicates Demodex mites by selectively inhibiting parasite-specific gamma-aminobutyric acid-gated chloride (GABA-Cl) channels. It is a highly lipophilic molecule, which may promote its uptake in the oily sebum of the eye lash follicles where the mites reside. About TP-04TP-04 is an investigational sterile aqueous gel formulation of lotilaner. Tarsus is studying TP-04 for the potential treatment of ocular rosacea (OR). About TP-05TP-05 is an investigational oral systemic formulation of lotilaner. TP-05 is believed to be the only non-vaccine, drug-based, preventative therapeutic in development designed to kill ticks to potentially prevent Lyme disease transmission. About Tarsus Pharmaceuticals, Inc.Tarsus Pharmaceuticals, Inc. applies proven science and new technology to revolutionize treatment for patients, starting with eye care. Tarsus is advancing its pipeline to address several diseases with high unmet need across a range of therapeutic categories, including eye care, dermatology, and infectious disease prevention. XDEMVY (lotilaner ophthalmic solution) 0.25% is FDA approved in the United States for the treatment of Demodex blepharitis. Tarsus is also developing TP-04 for the potential treatment of ocular rosacea and TP-05 as an oral tablet for the potential prevention of Lyme disease, all of which are in Phase 2. Forward-Looking StatementsStatements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include statements regarding the potential commercial success and growth of XDEMVY in Demodex blepharitis, including market size, acceptance, demand, prescription fill rate and adoption rate for XDEMVY; our ability to successfully continue our new direct-to-consumer campaign; our ability to achieve and maintain distribution and patient access for XDEMVY and breadth of payer coverage; our ability to continue to educate the market about Demodex blepharitis; our ability to initiate planned clinical studies; anticipated regulatory and development milestones including potential Europe and Japan regulatory pathways and approval for XDEMVY; the results of our clinical studies; the test results of our pipeline formulations; our ability to continue investing in our business and actively evaluate external opportunities, and the quotations of Tarsus’ management. The words, without limitation, “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would,” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Important factors that could cause actual results to differ materially from those in the forward-looking statements include: Tarsus is heavily dependent on the successful commercialization of its lead product, XDEMVY for the treatment of Demodex blepharitis and the development and regulatory approval and commercialization of its current and future product candidates; Tarsus’ ability to obtain and maintain regulatory approval for and successfully commercialize its products, including XDEMVY for the treatment of Demodex blepharitis, and its product candidates to meet existing and future regulatory standards; Tarsus has incurred significant losses and negative cash flows from operations since inception and anticipates that it will continue to incur significant expenses and losses for the foreseeable future; Tarsus’ capital requirements are difficult to predict and may change; Tarsus may need to obtain additional funding to achieve its goals and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force Tarsus to delay, reduce, or eliminate its product development programs, commercialization efforts or other operations; Tarsus may not be successful in educating healthcare professionals and the market about the need for treatments specifically for Demodex blepharitis and other diseases targeted by XDEMVY or our product candidates; the development and commercialization of Tarsus products is dependent on intellectual property it licenses from Elanco Tiergesundheit AG; Tarsus expects to expand its development, regulatory, operational, sales, and marketing capabilities and Tarsus may encounter difficulties in managing its growth, which could disrupt its operations; the sizes of the market opportunity for XDEMVY and Tarsus’ product candidates, particularly TP-04 for the potential treatment of ocular rosacea, as well as TP-05 for the potential prevention of Lyme disease, have not been established with precision and may be smaller than estimated; the results of Tarsus’ earlier studies and trials may not be predictive of future results; any termination or suspension of, or delays in the commencement or completion of, Tarsus’ planned clinical trials could result in increased costs, delay or limit its ability to generate revenue and adversely affect its commercial prospects; if Tarsus is unable to obtain and maintain sufficient intellectual property protection for its product candidates, or if the scope of the intellectual property protection is not sufficiently broad, Tarsus’ competitors could develop and commercialize products similar or identical to Tarsus’ products; and if Tarsus is unable to access capital (including but not limited to cash, cash equivalents, and credit facilities) and/or loses capital, as a result of potential failure of any financial institutions that Tarsus does business with directly or indirectly. Further, there are other risks and uncertainties that could cause actual results to differ from those set forth in the forward-looking statements and they are detailed from time to time in the reports Tarsus files with the Securities and Exchange Commission, including Tarsus’ Form 10-K for the year ended December 31, 2024 filed on February 25, 2025 and the most recent Form 10-Q quarterly filing filed with the SEC on November 4, 2025, which Tarsus incorporates by reference into this press release, copies of which are posted on its website and are available from Tarsus without charge. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Any forward-looking statements contained in this earnings release are based on the current expectations of Tarsus’ management team and speak only as of the date hereof, and Tarsus specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

上市批准临床结果临床2期财报

2025-10-27

·PRNewswire

Elanco Announces Expansion of Credelio Quattro™ (lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets) and Credelio™ (lotilaner) Labels, Offering Protection Against Lyme Disease and an Emerging Tick Species

FDA approves expanded Credelio Quattro and Credelio labels to include prevention of Lyme disease as a result of killing black-legged ticks (lxodes scapularis) and protection against the longhorned tick (Haemaphysalis longicornis), which is rapidly spreading, now reaching 22 states.i The Companion Animal and Parasite Council tracker shows more than 422,000 cases of Lyme disease in dogs so far this year,ii surpassing the total number of annual cases seen in all of 2019.iii Elanco continues to go beyond for veterinarians and pet owners, providing even more comprehensive protection against some of the most concerning ticks. INDIANAPOLIS, Ind., Oct. 27, 2025 /PRNewswire/ -- Elanco Animal Health Incorporated (NYSE: ELAN) today announced label expansions for two of its leading canine prescription parasiticides, Credelio Quattro (lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets) and Credelio (lotilaner), with both product labels updated to include: Prevention of Lyme disease as a direct result of killing black-legged ticks (lxodes scapularis) Treatment and control of longhorned tick (Haemaphysalis longicornis) infestations Given the rising threat of ticks and tick-borne disease, this expanded protection for dogs is timely. The Companion Animal and Parasite Council tracker shows more than 422,000 cases of Lyme disease in dogs so far this year,ii surpassing the total number of annual cases seen in all of 2019.iii On the human side, the CDC reported that this May had the highest level of tick bites seen in human emergency room visits since 2019.iv Pets and people can encounter ticks in common areas like the backyard or simply walking around the neighborhood, so it is important for dogs to be protected with a flea and tick treatment year-round. "This label expansion is a testament to Elanco's unwavering commitment to innovation and scientific excellence," said Dr. Ellen de Brabander, Executive Vice President, Innovation and Regulatory Affairs, at Elanco. "Our research and development teams are constantly working to anticipate and address emerging threats, ensuring and demonstrating that Credelio Quattro and Credelio continue to provide leading-edge protection for dogs against a complex and evolving parasitic landscape." Lotilaner vs. Lyme Disease The active ingredient lotilaner in both Credelio Quattro and Credelio has been found highly effective for killing the black-legged vector ticks (lxodes scapularis), which are the most common spreaders of Lyme disease.v Both labels in the U.S. now include a claim for prevention of Lyme disease in dogs as a direct result of killing black-legged ticks. With more than 422,000 cases of Lyme disease in dogs already recorded this year, northeast states including New York, Maine, New Hampshire, Vermont, Pennsylvania and Connecticut are a few of the states with the most positive cases.ii And it's not just cases of Lyme disease in dogs that are on the rise. A 2021 estimate suggests that each year, approximately 476,000 Americans are diagnosed and treated for Lyme disease.vi "With this label expansion, pet owners and veterinarians now have more options to protect dogs from Lyme disease," said Dr. Casey Locklear, veterinarian and parasiticide lead for Elanco Animal Health. "With higher positive cases of canine Lyme disease already confirmed this year by the CAPC,iv pet owners should ask their veterinarian for parasite protection that includes protection against Lyme disease, like Credelio Quattro or Credelio." Lotilaner vs. Longhorned Tick The longhorned tick is an invasive tick species that is rapidly spreading and is now in 22 states around the country,i posing a significant threat to animal and human health. The ticks' ability to transmit canine pathogens, like Ehrlichia and Babesia species also highlights its potential risk for dogs as the population continues to spread across the country.vii "The unique biology of the longhorned tick is what makes it a potential public health challenge," said Dr. Locklear. "They can establish populations of thousands from a single female because they have the ability to reproduce without mates." In a recent peer-reviewed and published study in Parasites and Vectors, both Credelio Quattro and Credelio demonstrated 100% efficacy against the longhorned tick at 48 hours after infestation and continuing throughout the month.viii Lotilaner vs. Lone Star Tick While both Credelio Quattro and Credelio were already approved to protect dogs from the lone star tick (Amblyomma americanum), the rise in tick infestations across the country reinforces the need for effective parasite control. This aggressive and expanding tick species is found across the country, is one of the hardest to kill, and is best known for its association with alpha-gal syndrome (red meat allergy) in humans. It can also transmit dangerous disease-causing pathogens to dogs.iv The active ingredient lotilaner in both Credelio Quattro and Credelio kills the lone star tick faster* than sarolaner in Simparica Trio® and afoxolaner in NexGard®, protecting dogs against this pathogen-carrying tick. "It is critical that veterinarians talk with pet owners about year-round parasite protection," said Dr. Kathryn Reif, Bailey-Goodwin Endowed Associate Professor in Parasitology at Auburn University. "The rapid and sustained speed of tick kill of Credelio Quattro and Credelio helps protect dogs against pathogen-carrying ticks which can result in dangerous diseases." "This expanded label for Credelio Quattro and Credelio is exciting for pet owners and veterinarians alike," said Bobby Modi, Executive Vice President, U.S. Pet Health and Digital Transformation at Elanco. "Our expanded label demonstrates even more comprehensive protection against some of the most concerning ticks, going beyond for both pet owners and veterinarians and helping dogs live healthier, happier, more active lives." To learn more about Credelio Quattro and Credelio and how they protect against emerging parasite threats, please visit QuattroDogVet.com and . ABOUT ELANCO Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders and society as a whole. With 70 years of animal health heritage, we are committed to breaking boundaries and going beyond to help our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People. Learn more at . CREDELIO INDICATIONS Credelio kills adult fleas and is indicated for the treatment and prevention of flea infestations and treatment and control of tick infestations (lone star tick, American dog tick, black-legged tick, brown dog tick, and longhorned tick) for one month in dogs and puppies 8 weeks and older and 4.4 pounds or greater. Credelio is indicated for the prevention of Lyme disease infections as a direct result of killing black-legged ticks. CREDELIO IMPORTANT SAFETY INFORMATION Lotilaner is a member of the isoxazoline class of drugs. This class has been associated with neurologic adverse reactions including tremors, incoordination, and seizures. Seizures have been reported in dogs receiving this class of drugs, even in dogs without a history of seizures. Use with caution in dogs with a history of seizures or neurologic disorders. The safe use of Credelio in breeding, pregnant or lactating dogs has not been evaluated. The most frequently reported adverse reactions are weight loss, elevated blood urea nitrogen, increased urination, and diarrhea. For complete safety information, please see Credelio product label or ask your veterinarian. CREDELIO QUATTRO INDICATIONS Credelio Quattro is indicated for the prevention of heartworm disease and the treatment and control of roundworm, hookworm, and tapeworm infections. Credelio Quattro kills adult fleas and is indicated for the treatment and prevention of flea infestations and the treatment and control of tick infestations for 1 month in dogs and puppies 8 weeks of age and older and weighing 3.3 pounds or greater. Credelio Quattro is indicated for the prevention of Lyme disease infections as a direct result of killing black-legged ticks. CREDELIO QUATTRO IMPORTANT SAFETY INFORMATION Lotilaner, an ingredient in Credelio Quattro, belongs to the isoxazoline class and has been associated with neurologic adverse reactions like tremors, incoordination, and seizures even in dogs without a history of seizures. Use with caution in dogs with a history of seizures or neurologic disorders. Dogs should be tested for existing heartworm infections before Credelio Quattro administration as it is not effective against adult heartworms. The safe use in breeding, pregnant, or lactating dogs has not been evaluated. The most frequently reported adverse reactions in clinical trials were vomiting and diarrhea. For complete safety information, please see the Credelio Quattro product label or ask your veterinarian. NexGard is a registered trademark of Boehringer Ingelheim Animal Health USA Inc. Simparica TRIO is a registered trademark of Zoetis Services LLC. Credelio, Credelio Quattro, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. Other company and product names are trademarks of their respective owners. © 2025 Elanco or its affiliates i Triltsch, O. (2025, August 28). Tiny invaders: The rise of the Asian longhorned tick. Michigan United Conservation Clubs: Join Us Today! ii Companion Animal Parasite Council. Parasite Prevalence Maps – Lyme Disease in Dogs, United States, 2025 (All Year). Accessed September 24, 2025. iii Companion Animal Parasite Council. Parasite Prevalence Maps – Lyme Disease in Dogs, United States, 2019 (All Year). Accessed September 24, 2025. iv Centers for Disease Control and Prevention. (n.d.). Where Ticks Live. Centers for Disease Control and Prevention. Retrieved August 8, 2024, from v Murphy M, Garcia R, Karadzovska D, Cavalleri D, Snyder D, Seewald W, Real T, Drake J, Wiseman S, Nanchen S. Laboratory evaluations of the immediate and sustained efficacy of lotilaner (Credelio™) against four common species of ticks affecting dogs in North America. Parasit Vectors. 2017 Nov 1;10(1):523. doi: 10.1186/s13071-017-2476-y. PMID: 29089057; PMCID: PMC5664823. vi Kugeler, K. J., Schwartz, A. M., Delorey, M. J., Mead, P. S., & Hinckley, A. F. (2021). Estimating the Frequency of Lyme Disease Diagnoses, United States, 2010–2018. Emerging Infectious Diseases, 27(2), 616-619. . vii Dye-Braumuller KC, Gual-Gonzalez L, Abiodun T, Rustin LP, Evans CL, Meyer MM, Zellars K, Neault MJ, Nolan MS. Invasive Haemaphysalis longicornis (Acari: Ixodidae) investigation in South Carolina: new records of establishment, pathogen prevalence, and blood meal analyses. J Med Entomol. 2023 Nov 14;60(6):1398-1405. doi: 10.1093/jme/tjad119. PMID: 37658780; PMCID: PMC10645392. viii Wiseman, S., Savadelis, M.D., Maree, R. et al. Efficacy of Credelio Quattro™ (lotilaner, moxidectin, pyrantel, praziquantel) and Credelio™ (lotilaner) against longhorned tick, Haemaphysalis longicornis,-induced infestations on dogs. Parasites Vectors 18, 344 (2025). * Based on time to statistical significance vs control in a head-to-head study. The study compared Credelio™ (lotilaner)—not Credelio Quattro™, which contains lotilaner as well as moxidectin, praziquantel, and pyrantel—to the active ingredients in Simparica Trio™ (sarolaner, moxidectin, and pyrantel) and NexGard™ (afoxolaner) Investor Contact: Tiffany Kanaga (765) 740-0314 [email protected] Media Contact: Season Solorio (765) 316-0233 [email protected] SOURCE Elanco Animal Health WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准

2025-10-26

·远大医药官微

远大医药全球创新眼科药物GPN00884在中国开展的IIa期临床研究完成了首例患者入组

GPN00884滴眼液是一款用于推迟儿童近视进展的全新作用机制的创新药。临床前及早期临床研究数据显示，与低浓度阿托品滴眼液相比，GPN00884滴眼液可避免或减少瞳孔散大效应及畏光、调节下降等不良反应，给药时段不受限制，可提高患者的依从性；中国是全球近视人数最多的国家，根据国家卫生健康委员会调查结果，中国青少年近视患病率高居世界第一，2022年，中国儿童青少年总体近视率为51.9%；目前在推迟儿童近视进展方面，国内尚缺乏疗效和安全性明确的药物，该疾病领域存在未被满足的临床需求。GPN00884滴眼液有望为医生和患者提供一种全新的推迟儿童近视进展的临床治疗方案。近日，远大医药(0512.HK)用于推迟儿童近视进展的全球创新眼科药物GPN00884在中国开展的IIa期临床研究完成了首例患者入组。该研究是一项随机、双盲、安慰剂平行对照的IIa期临床试验，拟入组80余例6~12周岁近视受试者，旨在初步评价GPN00884滴眼液推迟儿童近视进展的有效性及在儿童近视患者中的安全性。 GPN00884临床优势显著或提供全新延缓儿童近视进展方案关于GPN00884 GPN00884滴眼液是一款用于推迟儿童近视进展的全新作用机制的创新药。临床前及早期临床研究数据显示，与低浓度阿托品滴眼液相比，GPN00884滴眼液可避免或减少无瞳孔散大效应，及畏光、调节下降等不良反应，给药时段不受限制，可提高患者的依从性。目前在推迟儿童近视进展方面，国内尚缺乏疗效和安全性明确的药物，该疾病领域存在未被满足的临床需求。GPN00884滴眼液有望为医生和患者提供一种全新的推迟儿童近视进展的临床治疗方案。[1] 此前，GPN00884滴眼液已于2024年3月在中国获批开展I期临床研究，并于同年8月完成全部受试者入组，于2025年3月完成了I期临床研究，I期临床结果显示GPN00884在健康受试者中单次及多次给药后的安全性、耐受性良好，呈线性药代动力学特征。[2]此次，该产品IIa期临床研究的首例患者入组，是本集团在五官科板块眼科方向的又一次重大里程碑进展。关于近视近视是全球最严重的公共卫生问题之一。据世界卫生组织发布的《世界视觉报告》所示，于2020年全球近视患病人群达到26亿，其中3.12亿人在19岁以下；特别是亚太地区高收入国家近视患病率高达53.4%，远远高于澳洲、欧洲、美洲等地区。中国是全球近视人数最多的国家，根据国家卫生健康委员会调查结果，中国青少年近视患病率高居世界第一。2022年，中国儿童青少年总体近视率为51.9%[1]。Frost & Sullivan预测2030年中国20岁以下近视人数将达1.9亿人。儿童青少年近视呈现发病年龄早、进展快、程度深的趋势，发病率也不断攀升。 2018年中国教育部联合国家卫健委等八部门联合印发《综合防控儿童青少年近视实施方案》，国家卫生健康委员会后续也不断印发《“十四五”全国眼健康规划（2021-2025年）》《近视防治指南（2024年版）》等通知，近视防控已经上升为国家战略之一。受大量患者人数所驱动，近视治疗产品的临床与市场需求也将持续扩大。推进全球创新产品研发夯实眼科领域行业地位本集团始终以眼科领域作为重要战略发展方向之一，持续聚焦眼科药物创新，坚持专业化发展道路，不断提升行业地位和市场竞争力。目前，本集团已构建了“专业化、全系列、多品种”的创新药物产品体系，通过合作引进和自主研发相结合的策略，储备了治疗“干眼症”、“蠕形螨睑缘炎”、“眼科术后抗炎镇痛”、“翼状胬肉”和“近视”等多款全球创新产品，构建差异化竞争优势，且取得了重大研发进展，未来三年将有多款创新产品有望获批上市。[3] 其中，用于治疗干眼症的酒石酸伐尼克兰鼻喷雾剂（OC-01）是目前全球首款且唯一一款获批治疗轻、中、重度干眼的无防腐剂、多剂量、无菌包装鼻喷雾剂，该产品于2021年10月在美国获批上市，于2024年11月获得国家药监局批准上市，并于2025年7月在中国大陆实现首批商业化处方落地；用于抗炎镇痛的激素纳米混悬滴眼液GPN00833于2024年11月完成国内III期临床研究并成功达到了临床终点；用于治疗蠕形螨睑缘炎的全球创新眼科药物GPN01768（TP-03，洛替拉纳滴眼液，0.25%）已于2024年12月向国家药监局递交了新药上市申请并获得了受理，于2025年5月获得中国澳门特别行政区政府药物监督管理局批准上市；用于治疗翼状胬肉的创新改良型新药GPN00153 (CBT-001)于2024年3月完成国际多中心III期临床研究中国区域首例受试者入组，于2025年6月完成国际多中心III期临床研究全球中心全部受试者入组。[3] 未来，本集团将加快推进研发管线的全面化、差异化布局，不断丰富眼科细分领域的创新产品储备。此外，本集团在眼科领域已吸引和培养了一批兼具临床经验和营销经验的专业人士，建立了以客户为中心，学术为主导的专业化营销团队，形成了覆盖全国的营销网络。随着眼科创新产品的持续获批，本集团将充分发挥该领域的核心优势，持续深耕眼科前沿创新赛道，进一步加强核心产品的专业化推广和品牌建设，为本集团持续健康发展提供新动能。远大医药集团有限公司董事会表示：“本集团一直高度重视创新产品和先进技术的研发，未来将持续加大对全球创新产品和先进技术的投入，丰富和完善产品管线及产业布局，坚持‘全球化运营布局，双循环经营发展’策略，充分发挥本集团的产业优势和研发实力，快速将科技创新产品落地上市，为全球患者提供更先进更多样的治疗方案。” [1]根据现有公开信息； [2]根据I期临床试验数据，最终疗效与安全性需经完整临床研究及监管审批确认； [3]研发风险提示：文中提及的在研产品尚未获得上市批准，其安全性和有效性需经完整临床研究及监管审批确认，不构成任何治疗承诺或商业推广。对在研产品上市时间的任何预期仅为基于当前情况进行初步判断的前瞻性表述，具有相当风险和不确定性。 ▲远大医药全球创新温度敏感性栓塞剂在中国的注册性临床研究完成全部患者入组 ▲远大医药曲前列尼尔注射液新规格在中国大陆获批上市，全球权益赋能“Go Global”战略行稳致远 ▲远大医药受邀出席2025香港国际生物科技论坛暨展览：深耕核药全球布局创新成果惠及世界 ↑↓ 上下滑动了解更多 ➤关于远大医药远大医药（0512.HK）是一家科技创新型国际化医药企业，核心业务横跨制药科技、核药抗肿瘤诊疗及心脑血管精准介入诊疗科技、生物科技三大领域。集团以医药及生物工业为基础，以患者需求为核心，以科技创新为源动力，针对尚未满足的临床需求，加大对全球创新产品和先进技术的投入，丰富和完善产品管线，巩固和强化产业链布局，充分发挥本集团的产业优势和研发实力，为全球患者提供更先进更多样的治疗方案。经过近年的不懈努力，本集团发展基础更加稳健，经营规模更加巩固，业务结构逐步优化，经营方式持续提升，转型升级步伐加快，创新布局多点开花。本集团盈利能力持续增强，助力研发创新；良好的并购与整合能力，继续巩固发展规模；原料制剂一体化，完善产业链结构；业务与实体多元化，有效加强综合优势。 “稳增长、强创新、谋布局”，本集团将继续秉承“综合优势、创新引领和全球拓展”的发展理念，采用“自主研发和全球拓展双轮驱动，全球化运营布局和双循环经营发展”策略，形成国内国外双循环联动发展并相互促进的新格局，致力于成为一家受医生和患者尊重并还原于社会的科技创新型国际化医药企业。 ➤前瞻性声明本新闻稿旨在分享本集团业务相关动态及进展，仅供医疗卫生专业人士参阅，非广告用途。本新闻稿信息仅供参考，不作为诊疗依据，如有身体不适请及时就医，本集团不对任何药品和/或适应症作推荐。本新闻稿中可能会包含某些前瞻性表述。这些表述本质上具有相当风险和不确定性。在使用“预期”、“相信”、“预测”、“期望”、“打算”及其他类似词语进行表述时，凡与本集团有关的，均属于前瞻性表述。本集团并无义务不断地更新这些预测性陈述。这些前瞻性表述是基于本集团管理层在做出表述时对未来事务的现有看法、假设、期望、估计、预测和理解。这些表述并非对未来发展的保证，会受到风险不确性及其他因素的影响，有些是超出本集团的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展的影响，实际结果可能会与前瞻性表述所含资料有较大差别。本集团、本集团董事及雇员代理概不承担(1)更正或更新本网站所载前瞻性表述的任何义务;及(2)若因任何前瞻性表述不能实现或变成不正确而引致的任何责任。

临床1期临床2期

100 项与洛替拉纳相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	洛替拉纳	-	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
睑缘炎	美国	Tarsus Pharmaceuticals, Inc.	2023-07-24

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
蠕形螨感染	临床3期	美国	Tarsus Pharmaceuticals, Inc.	2021-04-29
莱姆病	临床2期	美国	Tarsus Pharmaceuticals, Inc.	2023-03-14
玫瑰痤疮	临床2期	加拿大	Tarsus Pharmaceuticals, Inc.	2023-03-01
睑板腺功能障碍	临床2期	美国	Tarsus Pharmaceuticals, Inc.	2022-08-03
疟疾	临床1期	美国	Tarsus Pharmaceuticals, Inc.	2021-06-18

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05454956 (Ersa, CTgov)	临床2期	蠕形螨感染 \| 睑缘炎 \| 睑板腺功能障碍	39	TP-03 Vehicle (BID Dosing)	願遞憲膚獵糧襯壓網鹽 = 齋遞獵憲淵選齋鬱範鹹顧艱顧糧憲廠選廠築積 (範壓獵積觸鹹醖鹽願願, 積選餘齋夢製襯艱遞構 ~ 鹽淵構餘膚夢選選餘簾) 更多	-	2025-10-01
				TP-03 (TID Dosing)	願遞憲膚獵糧襯壓網鹽 = 襯構鏇艱餘餘構鏇顧鏇顧艱顧糧憲廠選廠築積 (範壓獵積觸鹹醖鹽願願, 鑰範鑰簾鏇網鏇繭繭衊 ~ 繭糧積範膚構鹹夢繭簾) 更多
NCT05387083 (Corporate Publications) 人工标引	临床2期	莱姆病	-	lotilaner high dose	憲衊製簾衊淵獵憲積糧(遞憲夢淵鏇淵餘糧鬱糧) = 觸憲鹽鹽選觸範醖築醖構積齋鑰獵鑰積鹽窪製 (膚觸廠顧淵遞鏇窪廠襯, 1.4) 更多	积极	2024-02-22
				lotilaner low dose	憲衊製簾衊淵獵憲積糧(遞憲夢淵鏇淵餘糧鬱糧) = 遞膚廠網壓夢夢積窪遞構積齋鑰獵鑰積鹽窪製 (膚觸廠顧淵遞鏇窪廠襯, 6.3) 更多
NCT04475432 (Saturn-1, CTgov)	临床2/3期	蠕形螨感染 \| 睑缘炎	421	TP-03, 0.25% (Active)	壓鹹網衊鏇襯範網壓鹽(壓齋願鹹憲糧簾願遞製) = 夢遞窪醖醖積蓋鹽鹽鹽蓋齋積齋窪範憲構醖醖 (鑰範壓壓膚鬱壓鹽網願, 0.034) 更多	-	2023-12-21
				TP-03 Vehicle (Control)	壓鹹網衊鏇襯範網壓鹽(壓齋願鹹憲糧簾願遞製) = 願壓鹹願鬱顧糧醖淵繭蓋齋積齋窪範憲構醖醖 (鑰範壓壓膚鬱壓鹽網願, 0.018) 更多
NCT04784091 (Saturn-2, CTgov)	临床3期	蠕形螨感染 \| 睑缘炎	412	TP-03 (Active)	蓋餘獵鏇顧廠製窪糧壓(淵淵觸窪蓋製夢繭壓窪) = 襯夢築範願鑰醖鬱網鹽簾構繭獵選製衊願齋糧 (膚築簾觸鬱獵鏇憲選簾, 0.035) 更多	-	2023-12-21
				TP-03 Vehicle (Control)	蓋餘獵鏇顧廠製窪糧壓(淵淵觸窪蓋製夢繭壓窪) = 製製夢鹹憲網壓艱衊構簾構繭獵選製衊願齋糧 (膚築簾觸鬱獵鏇憲選簾, 0.023) 更多
CTR20220726 \| NCT05629390 (LIBRA, GlobeNewswire) 人工标引	临床3期	蠕形螨感染	-	TP-03	構鬱餘鹽衊鬱範構製夢(憲廠齋壓鹽蓋繭艱鏇願) = Results demonstrated statistically significant mite eradication in patients 膚壓鑰範壓繭築鹹顧鑰 (願鬱顧鏇憲憲蓋廠觸積 ) 更多	积极	2023-10-30
				vehicle
NCT04784091 (Saturn-2, Pubmed \| Ophthalmology)	临床3期	睑缘炎	-	Lotilaner Ophthalmic Solution 0.25%	選鹽廠選齋衊艱艱願遞(鬱繭鏇淵遞夢積製淵簾) = 繭鏇夢鏇網選鏇襯簾艱醖壓製鑰醖襯鑰願鏇範 (遞顧築製艱選網淵夢衊 ) 更多	积极	2023-10-01
				Lotilaner Ophthalmic Solution 0.25% (Vehicle without Lotilaner)	選鹽廠選齋衊艱艱願遞(鬱繭鏇淵遞夢積製淵簾) = 製積構範製醖鬱窪築繭醖壓製鑰醖襯鑰願鏇範 (遞顧築製艱選網淵夢衊 ) 更多
NCT04475432 \| NCT04784091 (Saturn-2, FDA) 人工标引	N/A	睑缘炎	833	XDEMVY	積鏇選壓選艱襯選鹽齋(網構齋觸淵糧壓淵積簾) = The most common ocular adverse reaction observed in controlled clinical studies with XDEMVY was instillation site stinging and burning which was reported in 10% of patients. Other ocular adverse reactions reported in less than 2% of patients were chalazion/hordeolum and punctate keratitis. 範鑰鏇廠築鬱鑰範獵鹹 (夢廠遞繭淵壓糧網願鬱 ) 更多	积极	2023-07-24
				Vehicle
NCT04475432 (Saturn-1, Pubmed)	临床2/3期	蠕形螨感染	421	Lotilaner ophthalmic solution, 0.25%	築顧鏇築範鬱網夢艱構(膚糧夢襯簾選艱衊網窪) = All ocular adverse events in the study group were mild, with the most common being instillation site pain. 餘醖構廠鹹艱鏇簾鏇窪 (餘觸廠衊醖獵糧齋窪遞 )	积极	2022-08-11
				Vehicle without lotilaner
NCT04784091 (Saturn-2, GlobeNewswire) 人工标引	临床3期	蠕形螨感染	412	Lotilaner	願製壓齋衊鬱製艱窪繭(鹹鹽醖觸憲繭築範繭構) = 範壓繭鬱選淵觸鑰窪衊獵構願鹽蓋鹽夢築觸鑰 (積齋選餘壓獵網觸願繭 ) 更多	积极	2022-05-02
				Placebo	願製壓齋衊鬱製艱窪繭(鹹鹽醖觸憲繭築範繭構) = 衊餘膚製醖製鏇廠繭觸獵構願鹽蓋鹽夢築觸鑰 (積齋選餘壓獵網觸願繭 ) 更多
ARVO2021	临床2期	睑缘炎	-	Lotilaner Ophthalmic Solution 0.25%	範繭簾願築構憲糧糧願(製製鬱夢廠醖餘齋積鹽) = 憲製夢襯願窪淵獵鬱遞鬱醖憲選襯蓋獵觸夢網 (窪築製艱艱製築築艱憲 ) 更多	-	2021-06-01
				Vehicle	範繭簾願築構憲糧糧願(製製鬱夢廠醖餘齋積鹽) = 鹽簾憲顧觸蓋製遞簾衊鬱醖憲選襯蓋獵觸夢網 (窪築製艱艱製築築艱憲 ) 更多