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.

Start Date27 Dec 2023

Sponsor / Collaborator

Tarsus Pharmaceuticals, Inc.

NCT05838170 / CompletedPhase 2

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).

Start Date01 Mar 2023

Sponsor / Collaborator

Tarsus Pharmaceuticals, Inc.

NCT05720364 / CompletedPhase 1

A Phase 1, Open-Label, Randomized, Single-Dose, Parallel-Group Study to Evaluate the Food Effect on the Pharmacokinetics of TP-05 Under Fed and Fasted Conditions in Healthy Participants

A Phase 1, Open-Label, Randomized, Single-Dose, Parallel-Group Study to Evaluate the Food Effect on the Pharmacokinetics of TP-05 under Fed and Fasted Conditions in Healthy Participants.

Start Date19 Jan 2023

Sponsor / Collaborator

Tarsus Pharmaceuticals, Inc.

100 Clinical Results associated with Lotilaner

100 Translational Medicine associated with Lotilaner

100 Patents (Medical) associated with Lotilaner

132

Literatures (Medical) associated with Lotilaner

01 Dec 2024·VETERINARY PARASITOLOGY

Efficacy and innocuity of lotilaner in the treatment of otodectic mange in ferrets

Article

Author: LEGAIN, M. ; Idee, A ; Legain, M ; Mosca, M ; Rene-Martellet, M ; PIN, D. ; MARDINI, D. ; Pin, D ; IDEE, A. ; Mardini, D ; MOSCA, M. ; RENE-MARTELLET, M.

Otodectes cynotis is a contagious ear mite generally responsible of a parasitic otitis. This prospective study evaluates the efficacy, safety and impact on quality of life (QoL) of oral lotilaner for the treatment of Otodectes infestation in ferrets. Ferrets of weight greater than 500 g, with Otodectes mites confirmed on ear swabs examination and that did not receive an acaricidal treatment in the previous two weeks were included. Oral lotilaner (Credelio 12 mg, ELANCO FRANCE, Sèvres, France) was administered at inclusion day (D0) and 28 days later (D28). Parasitic counts and clinical examination were performed at D0, D28 and D56. A QoL and owner satisfaction questionnaire was given at D0 and D56. Statistical analysis was performed with Shapiro-Wilk test for normality and Wilcoxon test for mean comparison (significance: p<0.05). Eleven ferrets were included, two were asymptomatic. Mean weight was 1.2 kg (0.68-2.66). Mean lotilaner dose was 12.3 mg/kg (9-17.6). Mean eggs, adults or nymphs, larvae, and fragments counts were 30.4 (3-104), 11.2 (1-61), 5.4 (0-36), 3.5 (1-7) respectively at D0; 0, 0, 0.1 (0-1), 0.5 (0-3) respectively at D28; 0, 0, 0, 0.14 (0-1) respectively at D56. Differences were statistically significant from baseline in all cases (p<0.05). Pruritus was absent in all cases at D56. No adverse effects were reported. All owners were "completely satisfied" with the treatment. Mean impact of the disease on QoL was 4.5/18 (SD=4.15) at D0 and 0 at D56 (significant difference, p<0.05). Oral lotilaner appears as a safe, efficient, easy to use and satisfactory treatment of Otodectes cynotis infestation in ferrets.

25 Nov 2024·Ocular immunology and inflammation

Efficacy and Safety of Lotilaner Ophthalmic Solution 0.25% in the Treatment of Demodex Blepharitis: A Systematic Review and Meta-Analysis

Review

Author: Abbas, Ahmed W. ; Elganady, Asmaa ; Abo Zeid, Mohamed ; Elrosasy, Amr ; Abu Serhan, Hashem ; Rhab, Ahmed Elhadi

PURPOSE:

To evaluate the safety and efficacy of Lotilaner ophthalmic solution 0.25% in the treatment of demodex blepharitis.

METHODS:

PubMed, Web of Science, Scopus, and Embase databases were searched. RCTs comparing lotilaner with placebo or any other standard treatments were included. Outcomes of mean collarette grade (MCG), mite density (Md), meaningful collarette reduction (MCR), mite eradication (ME), were pooled as mean difference (MD), and the outcomes of erythema cure (EC), collarette cure (CC) adverse events (AE) as risk ratio (RR) with their 95% confidence interval (CI) between the two groups from baseline to the endpoint. Review Manager (Version 5.4.1) software was used to conduct all statistical analyses.

RESULTS:

Four RCTs (947 patients) were included in this study. The overall effect favored the lotilaner group in terms of mean collarette grade upper lid (MD -0.99, 95% CI [-1.26, -0.72]), MCG lower lid (MD -0.57, 95% CI [-1.03, -0.11]), Md (MD -1.13, 95% CI [-1.47, -0.79]), MCR (MD 2.07, 95% CI [2.27, 3.21]), ME (MD 3.46, 95% CI [2.96, 4.04]). EC (RR 3.16, 95% CI [2.18 to 4.59]) and CC (RR 4.17, 95% CI [2.97 to 5.85]). No significant difference between the two groups in terms of AE (RR 1.25, 95% CI [0.75 to 2.06]). However, these findings are limited by significant heterogeneity in some of the reported outcomes.

CONCLUSIONS:

Our findings show that lotilaner might effectively treat Demodex blepharitis. However, further RCTs with larger and more diverse populations are needed to confirm these findings as some outcomes show significant heterogeneity.

01 Nov 2024·Cornea

Long-Term Outcomes of 6-Week Treatment of Lotilaner Ophthalmic Solution, 0.25%, for Demodex Blepharitis: A Noninterventional Extension Study

Article

Author: Berdy, Gregg J. ; Holdbrook, Mark ; Meyer, John ; Baba, Stephanie N. ; Ciolino, Joseph B. ; Jalalat, Parisa ; Paauw, James D. ; Nijm, Lisa ; Gaddie, Ian Benjamin ; Sadri, Ehsan ; Simmons, Blake ; Yeu, Elizabeth

Purpose::

The aim of this study was to evaluate the long-term outcomes of lotilaner ophthalmic solution, 0.25%, in the treatment of Demodex blepharitis.

Methods::

This observational, extension study included patients with Demodex blepharitis (N = 239) who completed the Saturn-1 study and presented for the day 180 visit. All participants were assessed at days 180 and 365 after the initiation of 6-week treatment with the study drug or its vehicle.

Results::

The proportion of patients with 0 to 2 collarettes (grade 0) was significantly higher in the study group (N = 128 patients) than in the control group (N = 111 patients) (39.8% vs. 2.7% at day 180 and 23.5% vs. 2.9% at day 365; P < 0.0001). Similarly, the proportion of patients with ≤10 collarettes (collarette grade 0–1) in the study group was significantly higher than in the control group (70.3% vs. 18.0% at day 180 and 62.6% vs. 21.9% at day 365; P < 0.0001). In the study group, erythema continued to improve even after completion of the 6-week lotilaner treatment. No serious ocular adverse events were observed in the study group, and there was 1 treatment-related ocular adverse event in the study group, which was considered mild.

Conclusions::

After 6-week treatment with lotilaner ophthalmic solution, 0.25%, for Demodex blepharitis, no long-term concerns were observed during 1 year of follow-up. A high proportion of patients with 0 to 2 collarettes (grade 0) or ≤10 collarettes (collarette grade of 0 or 1) was observed throughout 1 year of follow-up, indicating that the efficacy of lotilaner ophthalmic solution, 0.25%, against Demodex blepharitis may last well after completion of therapy.

News (Medical) associated with Lotilaner

25 Sep 2024

·www.globenewswire.com

Tarsus to Participate in Fireside Chat at UBS Virtual Ophthalmology Day 2024

IRVINE, Calif., Sept. 25, 2024 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, today announced that Aziz Mottiwala, Chief Commercial Officer, will participate in a virtual fireside chat at the UBS Virtual Ophthalmology Day 2024 taking place on Wednesday, October 2, at 6:00 a.m. PT / 9:00 a.m. ET. A live webcast and additional information about the presentation can be accessed on the events section of the Tarsus website. The replay will be available on the Tarsus website within 48 hours and will be archived for a limited time. 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-03 as an investigational therapy for the treatment of Meibomian Gland Disease, TP-04 for the treatment of rosacea and TP-05 as an oral tablet for the prevention of Lyme disease, all of which are in Phase 2. Media Contact:Adrienne KempSr. Director, Corporate Communications(949) 922-0801AKemp@tarsusrx.com Investor Contact:David NakasoneHead of Investor Relations(949) 620-3223DNakasone@tarsusrx.com

Drug ApprovalPhase 2

28 Aug 2024

·www.globenewswire.com

Tarsus to Participate in Fireside Chat at the 2024 Wells Fargo Securities Healthcare Conference

IRVINE, Calif., Aug. 28, 2024 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, today announced that Bobby Azamian, M.D., Ph.D., Chief Executive Officer and Chairman, and Jeff Farrow, Chief Financial and Chief Strategy Officer, will participate in an in-person fireside chat at the 2024 Wells Fargo Securities Healthcare Conference taking place in Boston, MA, on Wednesday, September 4, at 11:15 a.m. PT / 2:15 p.m. ET. A live webcast and additional information about the presentation can be accessed on the events section of the Tarsus website. The replay will be available on the Tarsus website within 48 hours and will be archived for a limited time. 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-03 as an investigational therapy for the treatment of Meibomian Gland Disease, TP-04 for the treatment of rosacea and TP-05 as an oral tablet for the prevention of Lyme disease, all of which are in Phase 2. Media Contact:Adrienne KempSr. Director, Corporate Communications(949) 922-0801AKemp@tarsusrx.com Investor Contact:David NakasoneHead of Investor Relations(949) 620-3223DNakasone@tarsusrx.com

Drug ApprovalPhase 2

15 Aug 2024

·www.prnewswire.com

Credelio® (lotilaner) Kills Ticks 2x as Fast as Simparica TRIO® (sarolaner, moxidectin and pyrantel) and NexGard® (afoxolaner)

Study finds that the aggressive lone star tick is no match for Credelio GREENFIELD, Ind., Aug. 15, 2024 /PRNewswire/ -- Parasites & Vectors, a leading peer-reviewed journal focused on parasites and vector-borne pathogens published the results of a head-to-head study demonstrating that Credelio, a prescription flea and tick protection product from Elanco Animal Health, has the fastest initial speed of tick kill in just 12 hours and sustains that advantage throughout the dosing interval.1,2,3 According to the Centers for Disease Control (CDC), during 2019 – 2022, state and local health departments reported more than 45,000 human cases of tickborne disease to CDC.4 The Companion Animal Parasite Council (CAPC) recommends using products on pets that kill and/or repel ticks before pathogens are transmitted.5 Continue Reading Dr. Kathryn Reif, Bailey-Goodwin Endowed Associate Professor in Parasitology at Auburn University, highlights the importance of the study findings. The 2023 head-to-head study compared three popular prescription flea and tick treatment products for dogs, Credelio (lotilaner), Simparica TRIO (sarolaner, moxidectin, pyrantel), and NexGard (afoxolaner), tracking the comparative data for the relative speeds of kill of Amblyomma americanum (lone star tick). The 2023 head-to-head study compared three popular prescription flea and tick treatment products for dogs, Credelio (lotilaner), Simparica TRIO (sarolaner, moxidectin, pyrantel), and NexGard (afoxolaner), tracking the comparative data for the relative speeds of kill of Amblyomma americanum (lone star tick) – an aggressive and expanding tick found in the United States that is one of the hardest to kill. Not only is this tick hard to kill, but it can also transmit dangerous disease-causing pathogens to pets and people. The CDC recently provided in-depth tick surveillance information regarding the aggressive nature of the lone star tick that can bite humans and transmit bacterial and viral pathogens, as well as cause alpha-gal syndrome (red meat allergy).6 "The results of this head-to-head study establishes Credelio as the front runner in speed of tick kill in prescription flea and tick treatment products for dogs.1 This is important because the longer a tick is attached, the greater the risk of pathogen transmission," said Dr. Kathryn Reif, Bailey-Goodwin Endowed Associate Professor in Parasitology at Auburn University. "These pathogens can cause serious diseases, such as Rocky Mountain Spotted Fever and ehrlichiosis, so it is critical that veterinarians talk with pet owners about year-round parasite protection. Credelio's rapid and sustained speed of tick kill helps protect pets against pathogen-carrying ticks which can result in dangerous diseases."1 The study included dogs that were randomly allocated to one of four treatment groups: Credelio, Simparica TRIO, NexGard or untreated control. Live tick counts were performed on dogs by blinded investigators during regular intervals.1 The study results found that by all 12-hour evaluation intervals, only the Credelio group significantly reduced lone star ticks as compared to the untreated control group. The study observed that the Simparica TRIO and NexGard groups were not significantly different from the untreated control group by any of the 12-hour evaluation intervals. The study also showed that Credelio significantly reduced ticks at all 12- and 24-hour evaluation time points and only Credelio provides a rapid speed of kill throughout the entire month-long treatment period.1,2,3 Of the evaluated products, only Credelio killed ticks as fast at the end of the month as at the beginning of the month. "This study sets Credelio apart from competitors as it maintains a rapid speed of tick kill throughout the entire monthly dosing period," said David Gosche, DVM, Elanco Sr. Director of Technical Marketing.1,2,3 "This product maintains consistent levels of efficacy in tick kill throughout the month, outperforming the competitors tested." 1,2,3 Learn more about Credelio for dogs here. To read the full study findings, click here. 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 nearly 70 years of animal health heritage, we are committed to helping 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 Elanco Healthy Purpose™ Sustainability Initiatives –all to advance the health of animals, people, and the planet. CREDELIO INDICATIONS Credelio kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations [Amblyomma americanum (lone star tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick) and Rhipicephalus sanguineus (brown dog tick)] for one month in dogs and puppies 8 weeks of age and older and weighing 4.4 pounds or greater. CREDELIO IMPORTANT SAFETY INFORMATION Lotilaner is a member of the isoxazoline class. This class has been associated with neurologic adverse reactions including tremors, ataxia, 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, polyuria, and diarrhea. For full prescribing information see Credelio package insert. NexGard is a registered trademark of Boehringer Ingelheim Animal Health USA Inc. Simparica TRIO is a registered trademark of Zoetis Services LLC. Credelio, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. Other company and product names are trademarks of their respective owners. © 2024 Elanco or its affiliates PM-US-24-1168 1 Ambylomma americanum (lone star tick) 2 Reif KE, Kollasch TM, Neilson JC, Herrin BH, Ryan WG, Bell MC, Beltz MS, Dryden MW, Jesudoss Chelladurai JRJ, Miller KR, Sutherland CJ. Comparative speed of kill provided by lotilaner (Credelio™), sarolaner (Simparica Trio™), and afoxolaner (NexGard™) to control Amblyomma americanum infestations on dogs. Parasite Vectors. 2024 Jul 20;17(1):313. 3 Based on the time to statistical significance vs control in a single study on days 21 and 28 for reinfestations. 4 Centers for Disease Control and Prevention. (n.d.). Tickborne Disease Surveillance Data Summary. Centers for Disease Control and Prevention. Retrieved August 8, 2024, from 5 Companion Animal Parasite Council | 2023 Annual Pet Parasite Forecasts (capcvet.org) 6 Centers for Disease Control and Prevention. (n.d.). Where Ticks Live. Centers for Disease Control and Prevention. Retrieved August 8, 2024, from Investor Contact: Katy Grissom (317) 273-9284 [email protected] Media Contact: Season Solorio (765) 316-0233 [email protected] SOURCE Elanco Animal Health

Clinical ResultClinical Study

100 Deals associated with Lotilaner

External Link

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Blepharitis	US	Tarsus Pharmaceuticals, Inc.	24 Jul 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Infestation by Demodex	Phase 3	US	Tarsus Pharmaceuticals, Inc.	29 Apr 2021
Lyme Disease	Phase 2	US	Tarsus Pharmaceuticals, Inc.	14 Mar 2023
Rosacea	Phase 2	CA	Tarsus Pharmaceuticals, Inc.	01 Mar 2023
Meibomian Gland Dysfunction	Phase 2	US	Tarsus Pharmaceuticals, Inc.	03 Aug 2022
Malaria	Phase 1	US	Tarsus Pharmaceuticals, Inc.	18 Jun 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04475432 (Saturn-1, CTgov)	Phase 2/3	Infestation by Demodex \| Blepharitis	421	TP-03, 0.25% (Active)	mducxejjnp(obnosysdxu) = vhywfnnfkk yevupcvkdw (kslnfmgeek, ynsannbpyg - bummzrzybt) View more	-	21 Dec 2023
				TP-03 Vehicle (Control)	mducxejjnp(obnosysdxu) = mcoscjwbfd yevupcvkdw (kslnfmgeek, zlwfwvzipo - pltwwxcdxa) View more
NCT04784091 (Saturn-2, CTgov)	Phase 3	Infestation by Demodex \| Blepharitis	412	TP-03 (Active)	jamcoublfo(yfflauyqzc) = hqmqsuxfzz isntgojjgr (wgcherygid, qoiwrvpnze - oqdeyujknt) View more	-	21 Dec 2023
				TP-03 Vehicle (Control)	jamcoublfo(yfflauyqzc) = hmlcbvsqwr isntgojjgr (wgcherygid, hxasirewbi - psmwtwwwin) View more
CTR20220726 \| NCT05629390 (LIBRA, GlobeNewswire) Manual	Phase 3	Infestation by Demodex	-	TP-03	rieoespsyx(wgpbhzuewn) = Results demonstrated statistically significant mite eradication in patients ozmkzibeig (xhjqxascwb ) View more	Positive	30 Oct 2023
				vehicle
NCT04784091 (Saturn-2, Pubmed \| Ophthalmology)	Phase 3	Infestation by Demodex	-	Lotilaner Ophthalmic Solution 0.25%	jpmubhjukr(wsspqjyuaf) = ktvtdkysfp ospeevbbwg (tqygpqbkgh ) View more	Positive	01 Oct 2023
				Lotilaner Ophthalmic Solution 0.25% (Vehicle without Lotilaner)	jpmubhjukr(wsspqjyuaf) = mgqfyqjdee ospeevbbwg (tqygpqbkgh ) View more
Saturn-2 (FDA) Manual	Not Applicable	Blepharitis	833	XDEMVY	vvmipfdsvk(tzbwnwikhp) = 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. gblsogoqcz (gckhpbajjm ) View more	Positive	24 Jul 2023
				Vehicle
NCT04784091 (Saturn-2, GlobeNewswire) Manual	Phase 3	Infestation by Demodex	412	Lotilaner	skhhdrkedc(vvifwatcor) = hgegeercjf jybryfomiq (bbmyuiujxz ) View more	Positive	02 May 2022
				Placebo	skhhdrkedc(vvifwatcor) = anfhfovvxf jybryfomiq (bbmyuiujxz ) View more
ARVO2021	Phase 2	Infestation by Demodex	-	Lotilaner Ophthalmic Solution 0.25%	vxtozjjqvw(zbauuzplro) = imwbehrdcs tojjszijzr (svoxzukqhc ) View more	-	01 Jun 2021
				Vehicle	vxtozjjqvw(zbauuzplro) = nihzfhrmsc tojjszijzr (svoxzukqhc ) View more
Mars Study (ARVO2020)	Not Applicable	-	15	TP-03 0.25%	rdfwdcadao(vuatfopipw) = No treatment-related adverse events were reported ffmcccnhyj (pwevmkpkiz )	Positive	01 Jun 2020

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