Lotilaner

Overview

Lotilaner is an ectoparasiticide that is a member of the isoxazoline family of compounds. Lotilaner has largely been used for veterinary uses as an antiparasitic agent to treat flea and tick infestations in animals. Lotilaner consists of two enantiomers: the S-enantiomer is active in vivo, while the R-enantiomer is reported to exhibit low biological activity. The active ingredient found in drug products of lotilaner is the S-enantiomer. On July 25, 2023, lotilaner was approved by the FDA for the treatment of Demodex blepharitis, making it the first and only approved therapeutic for this condition.

Indication

Lotilaner is indicated for the treatment of Demodex blepharitis.

Associated Conditions

Demodex Blepharitis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Impact of XDEMVY® on Demodex Blepharitis in Soft Contact Lens Wearers	2023/12/26	NCT06182358	Phase 4	Completed	Tarsus Pharmaceuticals, Inc.
Study of TP-04 in Participants With Papulopustular Rosacea	2023/05/01	NCT05838170	Phase 2	Completed	Tarsus Pharmaceuticals, Inc.
Trial to Evaluate the Efficacy and Safety of TP-03, LIBRA Study	2022/11/29	NCT05629390	Phase 3	Completed	LianBio LLC
Pilot Study Comparing the Safety and Efficacy of Two Dosing Regimens of TP-03 for the Treatment of MGD	2022/07/12	NCT05454956	Phase 2	Completed	Tarsus Pharmaceuticals, Inc.
Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis	2021/03/05	NCT04784091	Phase 3	Completed	Tarsus Pharmaceuticals, Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
XDEMVY	Tarsus Pharmaceuticals, Inc.	81942-125	OPHTHALMIC	2.5 mg in 1 mL	7/26/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

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Grandpharma's GPN01768 Receives Macao Approval for Demodex Blepharitis Treatment

5 months ago

• Grandpharma's innovative ophthalmic drug GPN01768 has been approved by Macao's Drug Regulatory Authority for treating Demodex blepharitis, marking a significant milestone for the company's ophthalmology portfolio. • The drug is the first and only FDA-approved treatment for Demodex blepharitis, generating approximately $180 million in U.S. revenue in 2024 with strong quarterly growth momentum. • This approval establishes a foundation for future regulatory submissions in the Greater Bay Area and mainland China, where over 40 million patients suffer from Demodex blepharitis with no currently marketed treatments. • Grandpharma has exclusive rights for GPN01768 development and commercialization in Greater China through a strategic partnership with Tarsus Pharmaceuticals.

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Tarsus Pharmaceuticals Advances Ocular Rosacea Program and Accelerates XDEMVY Launch

10 months ago

• Tarsus Pharmaceuticals is set to initiate a Phase 2 study of TP-04 (lotilaner ophthalmic gel) in the second half of 2025 for treating ocular rosacea. • XDEMVY (lotilaner ophthalmic solution, 0.25%) achieved $113 million in net product sales in the first nine months of 2024, with over 104,000 bottles delivered. • The company's direct-to-consumer advertising campaign for XDEMVY began in January 2025, coinciding with high-profile events like the Golden Globes. • Tarsus anticipates potential European regulatory approval for a preservative-free XDEMVY formulation by 2027 and awaits a decision on TP-03 in China.

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