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

AAD 2026: Almirall Presents New Clinical and Real‑world Evidence Across Atopic Dermatitis, Psoriasis, Actinic Keratosis and Acne (Businesswire) - "The company’s presence includes more than 15 scientific posters, led by 9 lebrikizumab presentations in atopic dermatitis (AD), new analyses on tirbanibulin (AK), two on tildrakizumab from the POSITIVE study, and two sarecycline pooled Phase 3 evaluations in acne."

Clinical data • Acne Vulgaris • Actinic Keratosis • Atopic Dermatitis • Psoriasis

Efficacy of sarecycline in the treatment of moderate-to-severe facial acne vulgaris (AV): Combined results from three phase 3 studies (AAD 2026) - "At 3 weeks after treatment initiation (first post-baseline evaluation), percent reductions in inflammatory lesions were –30.5% for sarecycline and –22.4% for placebo (P=0.0001). This pooled analysis demonstrates that sarecycline improves IGA and inflammatory lesions in moderate-to-severe AV, with improvements evident as early as week 3 and sustained over time."

Clinical • P3 data • Acne Vulgaris • Dermatology

Two Cases of Hidradenitis Suppurativa Treated with Sarecycline (AAD 2026) - "Given the chronicity and psychosocial burden of HS in children and adolescents, sarecycline may represent a promising alternative for patients who cannot tolerate or do not respond to traditional tetracyclines. Larger, controlled studies are warranted to confirm its safety, efficacy, and optimal dosing in this population."

Clinical • Acne Vulgaris • Dermatology • Fibrosis • Gastrointestinal Disorder • Hidradenitis Suppurativa • Immunology • Inflammation • Rosacea

Association Between Biologic Therapy and Acne Treatment Escalation Among Patients with Inflammatory Acne: A TriNetX Database Study (AAD 2026) - "Risk ratios (RRs) of systemic acne therapy (doxycycline, minocycline, sarecycline, spironolactone, or isotretinoin) were calculated. This may be attributable to further Th1/Th17 skewing as a result of biologic therapy, thereby exacerbating immune dysregulation and rendering patients refractory to topical treatments. Further studies are warranted to clarify the clinical significance and mechanistic basis of these findings."

Clinical • Acne Vulgaris • Atopic Dermatitis • Dermatitis • Immunology • Psoriasis

Beyond the Face: Treating Truncal Acne with Sarecycline - a Multinational Phase 3 Pooled Analysis. (AAD 2026) - " This pooled analysis evaluates the efficacy of sarecycline—a third-generation, narrow-spectrum tetracycline—for truncal acne using 12-week data from three previously reported Phase 3 randomized, placebo-controlled trials in the United States and China. Sarecycline improves truncal acne as early as week 3, with increasing efficacy over time and favorable tolerability in a racially diverse population."

P3 data • Retrospective data • Acne Vulgaris

Distinct Osteogenic Profiles of Tetracyclines from Different Generations in an Ex Vivo Embryonic Chick Femur Model. (PubMed, Int J Mol Sci) - "Organotypic femur cultures were maintained for 11 days and exposed to tetracycline (TC), doxycycline (DC), minocycline (MC), or sarecycline (SC), at 1 and 10 µg/mL, concentrations corresponding to clinically relevant local and systemic exposures. This study provides the first tissue-level, head-to-head comparison of four tetracyclines and their effects on bone biology. The findings indicate that tetracycline-induced osteogenic activity is both agent-specific and concentration-dependent, underscoring the importance of using lower doses to maximize osteogenic responses and supporting the preferential use of DC, MC, and SC in bone regeneration and adjunctive therapeutic applications."

Journal • Preclinical

Optimal Use Recommendations and Stewardship Principles with Oral Antibiotics in Acne Vulgaris Management: An Expert Consensus Panel. (PubMed, J Clin Aesthet Dermatol) - "The expert panel concluded that oral antibiotics can be used in the treatment of moderate-to-severe AV, oral antibiotics should be combined with topical treatments, and duration of use should be determined based on individualized patient care. Tetracyclines are recognized options for AV therapy, with sarecycline considered a preferred option for AV due to its targeted mode of action, unique ribosomal binding properties, narrow spectrum of antibiotic activity, lower bacterial resistance risk, and overall better tolerability. Additionally, tetracyclines should be avoided in pregnancy and in young children."

Journal • Review • Acne Vulgaris • Dermatology

Almirall Announces the Approval of Seysara in China for the Treatment of Moderate-to-Severe Acne (Businesswire) - "Sarecycline hydrochloride is the first oral antibiotic that was specifically developed for use in acne and is approved for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients 9 years of age and older... It is expected that the product will be available to physicians and patients in China in 2026."

China approval • Acne Vulgaris

No pharmacovigilance signal of intracranial hypertension associated with glycylcyclines: a FAERS-based disproportionality analysis. (PubMed, J Antimicrob Chemother) - "Although structurally related to tetracyclines, glycylcyclines are not associated with increased intracranial pressure based on current pharmacovigilance data. This may warrant re-evaluation of SmPC warnings and supports safer use in patients with suspected intracranial hypertension when no better alternatives are available."

Adverse events • Journal • Cardiovascular • CNS Disorders • Hypertension • Oncology

Efficacy and Safety of Sarecycline in Chinese Patients with Moderate-to-Severe Acne Vulgaris: Randomized Phase 3 Clinical Trial with Open-Label Follow-Up. (PubMed, Dermatol Ther (Heidelb)) - "Sarecycline was effective and had an acceptable safety profile in treating moderate-to-severe AV in Chinese patients, supporting its value for treating AV in this population."

Journal • P3 data • Acne Vulgaris • Dermatology

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