TP-04: An investigational therapeutic being studied for
the potential treatment of papulopustular rosacea (PPR)1
TP-04 is a topical, aqueous gel formulation of lotilaner in development for the potential treatment of papulopustular rosacea (PPR).1
According to the National Rosacea Society, approximately 16 million people in the US are affected by rosacea,2 a chronic skin disease characterized by facial redness, inflammatory lesions, burning, and stinging. PPR, estimated to occur in 18% to 28% of patients with rosacea, can result in redness, swelling, and/or pus-filled bumps.3-6
TP-04 is1:
Designed to potentially treat PPR and eradicate Demodex mites, which have been reported as highly prevalent in the skin of patients with rosacea, including those with PPR, and may play a key role in triggering inflammatory responses associated with the disease1,7
A topical gel formulation of lotilaner, a well-characterized antiparasitic agent that paralyzes and kills Demodex mites by selectively inhibiting parasite-specific GABA chloride channels8
Currently being evaluated in a Phase 2a trial1
GABA=gamma-aminobutyric acid.
Read about a chronic condition characterized by facial redness, flushing, and visible blood vessels.4
1. [Tarsus Initiates Phase 2 Trial Evaluating TP-04, a Novel, Aqueous Gel Formulation of Lotilaner, for the Treatment of Papulopustular Rosacea.] Press release. March 13, 2023. 2. Rosacea now estimated to affect at least 16 million Americans. Rosacea Review. Accessed August 11, 2023. https://www.rosacea.org/rosacea-review/2010/winter/rosacea-now-estimated-to-affect-at-least-16-million-americans 3. Abram K, Silm H, Oona M. Prevalence of rosacea in an Estonian working population using standard classification. Acta Derm Venereol. 2010;90(3):269-273. 4. Gether L, Overgaard LK, Egeberg A, Thyssen JP. Incidence and prevalence of rosacea: a systematic review and meta-analysis. Brit J Dermatol. 2018;179(2):282-289. 5. Kyriakis KP, Palamaras I, Terzoudi S, Emmanuelides S, Michailides C, Pagana G. Epidemiologic aspects of rosacea. J Am Acad Dermatol. 2005;53(5):918-919. 6. Tan J, Schofer H, Araviiskaia E, Audibert F, Kerrouche N, Berg M; RISE study group. Prevalence of rosacea in the general population of Germany and Russia – the RISE study. J Eur Acad Dermatol Venereol 2016; 30: 428-434. 7. Forton FM. The pathogenic role of Demodex mites in rosacea: a potential therapeutic target already in erythematotelangiectatic rosacea? Dermatol Ther (Heidelb). 2020;10(6):1229-1253. 8. Rosacea pipeline update: Tarsus starts phase 2A trial of TP-04 in PPR. Practical Dermatology. Published March 14, 2023. Accessed August 11, 2023. https://practicaldermatology.com/news/rosacea-pipeline-update-tarsus-starts-phase-2a-trial-of-tp-04-in-ppr
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