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

Sarecycline in Chinese Patients with Acne Vulgaris: Results from the Phase III Clinical Study (EADV 2026) - "Supported by Wuxi Zhiyan Biotechnology Co., Ltd."

Clinical • P3 data • Acne Vulgaris • Dermatology

New Agents for Acne Treatment and Updates to Isotretinoin Guidelines. (PubMed, Pediatr Clin North Am) - "New topical treatments include tazarotene lotion, trifarotene, combined microencapsulated benzoyl peroxide and tretinoin, minocycline foam, topical dapsone, and clascoterone cream. More recent systemic options include subantimicrobial doxycycline, sarecycline, combined oral contraceptives, spironolactone, and isotretinoin-lidose."

Journal • Review • Acne Vulgaris

Some Newer Antibiotics Active Against Helicobacter pylori and Anaerobic Bacteria and the Potential Benefits of Their Wider Availability in More Countries: A Narrative Review. (PubMed, Antibiotics (Basel)) - "Given the limited number of antibiotics for treating CDI and fidaxomicin nonavailability in many countries, it is necessary to conduct more extensive laboratory and clinical studies of promising antibiotics such as ibezapolstat, delafloxacin, lascufloxacin, omadacycline, eravacycline, ridinilazole, and CRS3123...Research on rifasutenizol for bacterial vaginosis, sarecycline and nadifloxacin for acne vulgaris and amixicile for periodontal diseases needs to be expanded. For H. pylori infection, delafloxacin, sitafloxacin, nemonoxacin, zoliflodacin, and rifasutenizol may improve the suboptimal success of most eradication regimens...Establishing more research groups, careful examination of market issues, and additional approaches, such as nanomaterials, efflux pump inhibitors, phage therapy, and CRISPR-Cas systems, should be beneficial. Notwithstanding the difficulties, there are many opportunities to promote research on and potential use of newer antibiotics which show..."

Journal • Review • Acne Vulgaris • Dental Disorders • Dermatology • Infectious Disease • Periodontitis • Vaginitis

Dual site targeting of the bacterial 70S ribosome by tetracyclines. (PubMed, Nat Commun) - "Structural comparison of Doxycycline, Minocycline, and Sarecycline bound to the Escherichia coli and Cutibacterium acnes 70S ribosome revealed species-specific differences affecting drug interaction and occupancy. Our results reveal a dual site mechanism of action for tetracyclines and provide a structural basis for rational design of narrow spectrum tetracyclines to overcome the rising threat of antibiotic resistance."

Journal • Acne Vulgaris • Dermatology • Infectious Disease • Inflammatory Arthritis • Lyme Disease • Pneumonia • Respiratory Diseases

Comparing Sarecycline and Doxycycline Effects on the Skin and Gut Bacteria in Acne. (clinicaltrials.gov) - P4 | N=30 | Recruiting | Sponsor: Integrative Skin Science and Research

New P4 trial • Acne Vulgaris • Dermatology

Beyond Isotretinoin: A Narrative Review of Emerging Systemic Therapies for Moderate-to-Severe Acne. (PubMed, J Cosmet Dermatol) - "Several systemic options beyond isotretinoin have emerged, showing potential in specific subgroups or as adjunctive therapies. However, further large-scale comparative studies are needed to define their roles within evidence-based acne management algorithms."

Journal • Review • Acne Vulgaris • Dermatology • Inflammation • Polycystic Ovary Syndrome

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

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

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