Tarsus Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company, which focuses on the development and commercialization of therapeutic candidates. Its product candidate, TP-03, is a novel therapeutic in Phase 2b/3 that is being developed for the treatment of blepharitis caused by the infestation of Demodex mites, which is referred to as Demodex blepharitis. The company was founded by Bobak Azamian and D. Michael Ackermann in 2017 and is headquartered in Irvine, CA.
Clinical Trials
15
6 active
Approvals
2
Total approvals
Agencies
1
Regulatory bodies
Founded
2017
Active, not recruiting
5
33.3%
Completed
9
60.0%
Enrolling By Invitation
1
6.7%
- Tarsus Pharmaceuticals announced plans to acquire Alkeus Pharmaceuticals for $270 million in cash and $180 million in stock, with up to $350 million in additional milestone payments. - The deal centers on gildeuretinol (ALK-001), a late-stage investigational therapy for Stargardt disease that has received Breakthrough Therapy, Rare Pediatric Disease, Fast Track, and Orphan Drug designations from the FDA. - In the TEASE-1 study, gildeuretinol slowed the growth rate of atrophic retinal lesions by 29.5% versus placebo, and TEASE-3 interim data showed a 21% reduction in lesion growth rate (p<0.001). - The acquisition, expected to close in 2026, expands Tarsus's presence in the retina space and follows its recent agreement to acquire iRenix Medical.
- Tarsus Pharmaceuticals has dosed the first participant in the Phase 2 Calliope trial evaluating TP-05 (lotilaner), a novel oral tablet designed to prevent Lyme disease by killing infected ticks before transmission. - The randomized, double-blind, placebo-controlled trial will enroll approximately 700 healthy adults at risk for Lyme disease across endemic U.S. regions, with topline results expected in the first half of 2027. - Previous Phase 2a data showed TP-05 achieved over 90% tick kill rates within 24 hours compared to 5% for placebo, representing a potential paradigm shift from treatment to prevention for the most common vector-borne disease in the United States.
- Tarsus Pharmaceuticals has appointed David E. I. Pyott, former Chairman and CEO of Allergan, to its Board of Directors to support the company's growth strategy. - Pyott transformed Allergan from a $1 billion eye care business into a global specialty pharmaceutical leader generating over $7 billion in revenue during his 17-year tenure. - The appointment comes as Tarsus advances its eye care portfolio, including FDA-approved XDEMVY for Demodex blepharitis and Phase 2 programs for ocular rosacea and Lyme disease prevention. - Pyott's extensive experience in eye care innovation and global commercial execution is expected to support Tarsus's pipeline development and market expansion efforts.
- DelveInsight's 2025 pipeline report identifies 7+ companies developing novel Lyme disease therapies, with emerging treatments including BLB 400, FP-100, CT38, TP-05, and VLA15 expected to significantly impact the market. - Valneva and Pfizer reported positive Phase II booster results for their Lyme disease vaccine candidate VLA15 in September 2024, following completion of the primary vaccination series for their Phase III VALOR trial in July 2024. - Tarsus Pharmaceuticals announced encouraging results from their Phase IIa "Tick-Kill" trial of TP-05 (lotilaner) for Lyme disease prevention in February 2024. - The pipeline spans multiple development stages from preclinical to Phase III, with various routes of administration including oral, parenteral, intravenous, subcutaneous, and topical formulations.
• 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.
• 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.
• Miebo (perfluorohexyloctane ophthalmic solution) achieved approximately $162.6 million in sales in its first full year, with 18,000 eye doctors prescribing it, demonstrating strong market acceptance for dry eye disease treatment. • Xdemvy (lotilaner ophthalmic solution 0.25%) reached approximately $126 million in sales within its first year, with 13,000 doctors prescribing it, highlighting successful disease state awareness for Demodex blepharitis. • Clinical data indicates Miebo provides rapid relief from dry eye symptoms, with patients reporting significant improvement in as little as 3 days, while Xdemvy improves meibomian gland function and reduces related symptoms. • Both medications have secured substantial insurance coverage, with approximately 70% to 80% of insured patients having access, suggesting favorable market access and cost management strategies.
