Seysara (sarecycline) / Almirall, Paratek Pharmaceuticals - LARVOL DELTA

A Single-Center Pilot Study to Evaluate the Efficacy, Safety, and Tolerability of Sarecycline for Treating Periorificial Dermatitis. (PubMed, J Drugs Dermatol) - "Sarecycline may be an appropriate novel treatment option for POD and should be explored further in a larger population study capturing this data. Furthermore, there is a need for more large-scale clinical studies evaluating treatment options for POD, with a focus on the impacts of antibiotic resistance and its implications on public health."

Journal • Dermatitis • Dermatology • Immunology

Antibiotic stewardship in dermatology: An analysis of acne vulgaris prescribing practices (SID 2025) - "Data points included demographics, prescriptions for topical and oral antibiotics, benzoyl peroxide, topical combination therapies, oral isotretinoin, oral contraceptives, spironolactone, and topical dapsone...Oral antibiotics were prescribed to 35.1% of patients, with doxycycline being the most common prescribed at 97%, followed by minocycline and sarecycline...The mean duration of antibiotic therapy at 7 months exceeds the guideline-recommended duration of 3–4 months, underscoring the importance of aligning practices with stewardship principles. To mitigate the risks of prolonged antibiotic use, future efforts should focus on provider education and the integration of updated guidelines into clinical practice to promote more judicious use of oral antibiotics."

Acne Vulgaris • Dermatology

Disparities in acne prescription patterns in underrepresented groups: insights from the all of us database. (PubMed, Arch Dermatol Res) - No abstract available

Journal • Acne Vulgaris • Dermatology

A Cross-Sectional Study Analyzing Recent Trends in the Treatment of Acne Vulgaris: Prescription Patterns and Demographic Data From the 2018-2019 National Ambulatory Medical Care Survey (NAMCS) Database. (PubMed, Cureus) - " Our findings indicate a shift in acne management patterns, characterized by a rise in antiandrogenic therapies and a reduction in oral antibiotic use, suggesting heightened antibiotic stewardship efforts. The elevated frequency of isotretinoin prescriptions likely reflects the iPledge program requirements for periodic follow-up visits rather than an actual increase in disease severity. While these trends underscore ongoing changes in clinical practice, further longitudinal research is warranted to assess how these prescription shifts influence long-term patient outcomes."

Journal • Observational data • Acne Vulgaris • Dermatology

Almirall 2024 Full-Year Results: Almirall Surpassed Guidance for 2024 - Entering an Era of Sustained Growth and Further Advancing Its Medical Dermatology Pipeline (Businesswire) - "After the approval of Ebglyss (lebrikizumab) by the European Commission (EC)...the product has now launched in 11 countries in Europe...and in 2025: Italy, Switzerland, Austria, Belgium, and Sweden). The rollout in the remaining European countries is expected throughout 2025....Sarecycline’s (Seysara) regulatory review in China is ongoing with an anticipated approval in the second half of 2025. To expand the label for Klisyri to include large field application also in Europe, a current clinical study is aimed at enabling approval for an anticipated launch in 2026....Sun Pharma is running two Phase III studies to assess the efficacy and safety of tildrakizumab in patients suffering from psoriatic arthritis. First results are expected in the second half of 2025....The company is continuing to advance the asset ALM27134...The start of a Phase II study is planned for later this year in patients suffering from Hidradenitis Suppurativa."

China approval • Launch Europe • New P2 trial • P3 data • Dermatology • Hidradenitis Suppurativa • Psoriatic Arthritis

C10-Benzoate Esters of Anhydrotetracycline Inhibit Tetracycline Destructases and Recover Tetracycline Antibacterial Activity. (PubMed, ACS Infect Dis) - "Semisynthetic modification of TCs (e.g., tigecycline, omadacycline, eravacycline, and sarecycline) has proven effective in evading certain resistance mechanisms, such as ribosomal protection and efflux, but does not protect against TDase-mediated resistance. The best inhibitors recovered tetracycline antibiotic activity at concentrations as low as 2 μM, producing synergistic scores <0.5 in the fractional inhibitory concentration index (FICI) against TDase-expressing strains of E. coli and clinical P. aeruginosa. The C10-benzoate ester derivatives of aTC reported here are promising new leads for the development of tetracycline drug combination therapies to overcome TDase-mediated antibiotic resistance."

Journal

Innovations in Acne. (PubMed, Dermatol Clin) - "The mechanisms of action, pivotal trial data, and potential role in clinical practice are reviewed for emerging therapies such as 1726 nm laser, sarecycline, clascoterone, trifarotene, minocycline foam, and fixed-dose combination topicals. The clinical pipeline is also summarized. In addition, opportunities to improve the patient experience with spironolactone and isotretinoin are discussed."

Journal • Review • Acne Vulgaris • Dermatology

Sarecycline for moderate to severe acne: a promising narrow-spectrum antibacterial drug. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "Other outcomes were not statistically significant. Sarecycline 1.5 mg/kg daily is an effective and well-tolerated treatment for moderate to severe acne with minimal side effects."

Journal • Acne Vulgaris • Dermatology

Tetracyclines revisited: tetracyclines in the field of dermatology. (PubMed, Dermatology) - "We also focus on the recently approved sarecycline, a third generation narrow-spectrum tetracycline, and its clinical efficacy and potential impact on the microbiome. Our review provides a better understanding of this extremely familiar drug class and encourages its use in a wider spectrum of dermatologic diseases and symptoms."

Journal • Review • Acne Vulgaris • Alopecia • Atopic Dermatitis • Dermatitis • Dermatology • Hidradenitis Suppurativa • Immunology • Kaposi Sarcoma • Oncology • Rosacea • Sarcoma • Solid Tumor • Urticaria • Vitiligo

An update on the pharmacological management of acne vulgaris: the state of the art. (PubMed, Expert Opin Pharmacother) - "Topical therapies such as topical retinoids, benzoyl peroxide, azelaic acid, salicylic acid, topical antibiotics and clascoterone, as well as systemic treatments such as oral antibiotics and isotretinoin are discussed in detail. Combined oral contraceptives and spironolactone will not be discussed in this article. There is a need for a blockbuster acne drug that simultaneously targets the 4 main pathogenic factors involved in the appearance of acne lesions while presenting with minimal side effects. Until such a drug exists, combination therapy will remain the standard of treatment for most acne patients."

Journal • Review • Acne Vulgaris • Dermatology • Inflammation

To Acne and Beyond: A Review of Sarecycline's Off-Label Uses. (PubMed, J Drugs Dermatol) - No abstract available

Journal • Review • Acne Vulgaris

P-doped carbon dot nano-probe for inner filter effect-based determination of sarecycline in pharmaceutical dosage form and human plasma. (PubMed, Luminescence) - "The new probe's enhanced sensitivity, broad linear range, and acceptable selectivity made it suitable for SAR measurement in pharmaceutical formulations and spiked human plasma. Most importantly, the Green Analytical Procedure Index (GAPI) and Analytical GREEnness (AGREE) assessments showed that the suggested method was environmentally friendly."

Journal

Systematic analysis of the adverse effects of commonly used clinical tetracycline drugs based on the FAERS database. (PubMed, Expert Opin Drug Saf) - "We used the pharmacovigilance analysis tool Open Vigil 2.1 to access FAERS data and obtained AE reports from January 2004 to June 2023, including doxycycline, minocycline, tigecycline, omadacycline, sarecycline, and eravacycline as the top suspect drugs. We found some AEs not mentioned in the instruction, such as the ototoxicity of tetracyclines. Doxycycline was associated with psychiatric side effects; minocycline presented in thyroid and skin tissue-associated tumors; abnormal signals were detected with eravacycline in the blood system."

Adverse events • Journal • Gastrointestinal Disorder • Oncology • Psychiatry

A Retrospective Review of a Cohort of Patients with Periorificial Dermatitis Treated with Sarecycline. (PubMed, J Clin Aesthet Dermatol) - "Narrow-spectrum tetracyclines, such as sarecycline, have a low potential for promoting bacterial resistance and gastrointestinal issues. There is a need for more large-scale clinical studies evaluating treatment options for POD. Based on the efficacy and tolerability of sarecycline in large- scale acne studies, sarecycline may be an appropriate novel treatment option for POD and should be explored further."

Journal • Retrospective data • Review • Acne Vulgaris • Atopic Dermatitis • Dermatitis • Dermatology • Gastrointestinal Disorder • Immunology

Study to Evaluate the Efficacy, Safety, and Tolerability of Sarecycline for Treating Periorificial Dermatitis (clinicaltrials.gov) - P4 | N=9 | Completed | Sponsor: The Dermatology Institute of Boston | Recruiting ➔ Completed

Trial completion • Dermatitis • Dermatology • Immunology

Study to Evaluate the Efficacy, Safety, and Tolerability of Sarecycline for Treating Periorificial Dermatitis (clinicaltrials.gov) - P4 | N=10 | Recruiting | Sponsor: The Dermatology Institute of Boston

New P4 trial • Dermatitis • Dermatology • Immunology

Treatment success with sarecycline for treatment of acne vulgaris (AV): Comparison of results from randomized controlled trials (RCTs) and the real-world (RW) PROSES study (AAD 2024) - P=N/A, P3 | "Comparison of results from the phase 3 RCTs for sarecycline with those from PROSES suggests that the RW effectiveness of this narrow-spectrum, tetracycline-derived antibiotic is at least equivalent to the efficacy reported in the controlled trials supporting its approval."

Clinical • Real-world • Real-world evidence • Acne Vulgaris • Dermatology

Safety of sarecycline for treatment of acne vulgaris (AV): Real-world results from the PROSES study (AAD 2024) - "Results from PROSES showed that sarecycline, a narrow-spectrum, tetracycline-derived antibiotic, was safe when administered to adult and pediatric patients for 12 weeks in a real-world setting."

Clinical • Real-world • Real-world evidence • Acne Vulgaris • Cardiovascular • CNS Disorders • Dermatology • Gastrointestinal Disorder • Hypertension • Pain • Pediatrics

Efficacy and Safety of Sarecycline in Chinese Patients with Acne Vulgaris: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase-3 Trial (AAD 2024) - "Introduction Sarecycline is a novel, narrow-spectrum, tetracycline-derived antibiotic approved in the US for the treatment of moderate-to-severe acne vulgaris in patients aged ≥9 years [1, 2]. Hyperuricemia, urinary tract infection, and upper respiratory tract infection were most reported. Conclusion Sarecycline significantly improved inflammatory facial lesions in Chinese patients with moderate-to-severe acne over 12 weeks and had an acceptable safety profile, consistent with previous studies in predominantly Caucasian patients [3]."

Clinical • P3 data • Acne Vulgaris • Dermatology • Infectious Disease • Nephrology • Respiratory Diseases

Sarecycline as a Potential Treatment for Steroid-Induced Rosacea/Perioral Dermatitis: A Case Report. (PubMed, J Drugs Dermatol) - No abstract available

Journal • Dermatitis • Dermatology • Immunology • Rosacea

INDIVIDUAL ARTICLE: Impact of Acne Vulgaris and Sarecycline on Social/Emotional Functioning and Daily Activities: PROSES Study. (PubMed, J Drugs Dermatol) - "Over 12 weeks of AV management with oral sarecycline, patients reported significant reductions in AV-related effects on emotional/social functioning and ADL as measured by the EPQ, a simple PRO with potential for use in clinical practice. J Drugs Dermatol. 2024;23:1(Suppl 1):s4-11."

Journal • Acne Vulgaris • Dermatology

INDIVIDUAL ARTICLE: Sarecycline Improves Acne Severity, Symptoms, and Psychosocial Burden in Non-nodular Acne Vulgaris: PROSES Study. (PubMed, J Drugs Dermatol) - "Patients with moderate-to-severe AV receiving acne management with an oral antibiotic for 12 weeks experienced a significant improvement in AV-related symptoms and psychosocial burden. J Drugs Dermatol. 2024;23:1(Suppl 1):s12-18."

Journal • Acne Vulgaris • Dermatology

Guidelines of care for the management of acne vulgaris. (PubMed, J Am Acad Dermatol) - "These guidelines provide evidence-based recommendations for the management of acne vulgaris."

Journal • Acne Vulgaris • Dermatology

Drugs for acne. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Acne Vulgaris

Clinically Approved Antibiotics from 2010 to 2022. (PubMed, Chimia (Aarau)) - "This review discusses small molecule antibiotics approved for clinical use in the time frame 2010-2022. This time span saw the approval of four synthetic antibiotics (bedaquiline, pretomanid, delafloxacin, tedizolid), nine natural product derivatives (ceftaroline fosamil, cefiderocol, plazomicin, omadacycline, eravacycline, sarecycline, lefamulin, dalbavancin, oritavancin), and one natural product (fidaxomicin)."

Journal • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis