This section highlights FDA-related milestones and regulatory updates for drugs developed by Tarsus Pharmaceuticals (TARS).
Over the past two years, Tarsus Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
TP-05, TP-03, and XDEMVY. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
TP-05 (lotilaner) FDA Regulatory Events
TP-05 (lotilaner) is a drug developed by Tarsus Pharmaceuticals for the following indication: For the Prevention of Lyme Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TP-05 (lotilaner)
- Announced Date:
- March 31, 2026
- Indication:
- For the Prevention of Lyme Disease
Announcement
Tarsus Pharmaceuticals, Inc. announced that the first participant has been dosed in the Phase 2 clinical trial (Calliope) evaluating TP-05 (lotilaner), a novel investigational oral therapy designed to potentially prevent Lyme disease by killing Lyme-infected ticks before disease transmission occurs.
AI Summary
Tarsus Pharmaceuticals announced the first participant has been dosed in the Phase 2 Calliope trial of TP-05 (lotilaner), an investigational oral therapy intended to prevent Lyme disease by killing infected ticks before they can transmit infection. Calliope is a randomized, double-blind, placebo-controlled study testing safety, tolerability and pharmacokinetics of oral TP-05 in about 700 healthy adults at risk across Lyme-endemic regions of the United States. Tarsus expects to finish enrollment during the 2026 tick season and to report topline results in the first half of 2027.
TP-05 is a systemic oral formulation of lotilaner and is believed to be the only non-vaccine, drug-based prophylactic in development focused on killing ticks to stop transmission. The trial will evaluate whether dosing people reduces the chance of infection and will gather safety and drug-level data to support further development.
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TP-03 FDA Regulatory Events
TP-03 is a drug developed by Tarsus Pharmaceuticals for the following indication: Demodex Blepharitis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TP-03
- Announced Date:
- March 23, 2026
- Indication:
- Demodex Blepharitis
Announcement
Tarsus Pharmaceuticals, Inc. announced that a $15 million milestone payment due Tarsus has been achieved following regulatory approval of TP-03 (lotilaner ophthalmic solution) 0.25%, marketed as XDEMVY® in the U.S., by the National Medical Products Administration (NMPA) of the People's Republic of China.
AI Summary
Tarsus Pharmaceuticals announced that a $15 million milestone payment has been achieved after the National Medical Products Administration (NMPA) of the People’s Republic of China approved TP-03 (lotilaner ophthalmic solution) 0.25%, which is marketed in the U.S. as XDEMVY®. The approval was obtained by Grand Pharmaceutical Group Limited (Grand Pharma), which secured the regulatory authorization in China.
Grand Pharma is Tarsus’ exclusive partner for the development and commercialization of TP-03 for treating Demodex blepharitis across Greater China — the People’s Republic of China, Hong Kong, Macau and Taiwan. Demodex blepharitis is an eyelid inflammation linked to tiny mites. The NMPA approval triggers the contractual milestone payment and marks a step toward making the treatment available to patients in the region while advancing Tarsus’ international commercialization efforts.
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XDEMVY FDA Regulatory Events
XDEMVY is a drug developed by Tarsus Pharmaceuticals for the following indication: For the treatment of Demodex blepharitis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- XDEMVY
- Announced Date:
- February 25, 2025
- Indication:
- For the treatment of Demodex blepharitis
Announcement
Tarsus Pharmaceuticals, Inc. announced recent business achievements.
AI Summary
Tarsus Pharmaceuticals, Inc. has made impressive strides in its business achievements during the first full year of XDEMVY’s launch. The company reported fourth quarter net product sales of $66.4 million and full‐year net sales of $180.1 million, highlighting one of the most successful eye care launches to date. XDEMVY demonstrated clear benefits by improving both disease signs and patient symptoms for those suffering from Demodex blepharitis and Meibomian Gland Disease. This success was supported by expanded outreach, with prescriptions increasing significantly as more than 15,000 eye care professionals began to utilize the product. Tarsus further strengthened its market presence by launching a direct-to-consumer campaign across streaming and network TV platforms, which has received positive initial feedback. The company’s strong performance positions it well as it continues to pursue additional innovative treatments in eye care.
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