Vowst (fecal microbiota spores, live-brpk) / Seres Therap, Nestle - LARVOL DELTA

Adverse Event Profiles of Orally and Rectally Administered Fecal Microbiota Live Biotherapeutics for Recurrent Clostridioides difficile Infection: A Disproportionality Analysis of FAERS (ACG 2026) - "Two are FDA-approved: fecal microbiota, live-jslm, given rectally, and fecal microbiota spores, live-brpk, given orally. We identified 987 reports for the oral product and 229 for the rectal product. Both profiles were dominated by gastrointestinal and disease related events: diarrhea (oral 47.5%, rectal 35.8%), recurrent CDI (24.9% in both), abdominal pain, nausea, and drug ineffectiveness. Death was reported in 1.1% (oral) and 0.9% (rectal)."

Adverse events • Gastroenterology • Infectious Disease • Nephrology • Septic Shock • ROR1

Cost-effectiveness of Fecal Microbiota Spores, Live-brpk for the Prevention of Recurrent Clostridioides difficile Infection in the United States (ACG 2026) - "FDA-approved microbiome therapies fecal microbiota, live-jslm (RBL) and fecal microbiota spores, live-brpk (VOS), are available for prevention of rCDI. VOS at first recurrence was dominant (cost-saving and more effective) versus both SoC and RBL. Compared with SoC, VOS reduced total per-patient costs by $2,247 ($37,327 vs $39,574), averted 0.74 (0.53 vs 1.27) subsequent recurrences, and produced 0.07 additional QALY (net monetary benefit [NMB]: $9,431 at $100,000/QALY threshold). Compared with RBL, VOS reduced costs by $1,962, averted 0.41 recurrences, and produced 0.04 additional QALY (NMB: $5,927)."

Cost effectiveness • HEOR • Infectious Disease

A Novel Ecological Control and Optimization Model for Recurrent Clostridioides difficile Infection (ACG 2026) - "Fixed-protocol simulations reproduce Phase 3 RCT outcomes: SER-109 achieved 8-week recurrence of 12% versus 40% with placebo; pooled 24-week recurrence was 15.2%. REBYOTA demonstrated 70.6% treatment success versus 57.5% placebo at 8 weeks, with 90.5% sustained response at 6 months. Shannon diversity increased significantly by Week 1 with SER-109 (P< 0.001)."

Infectious Disease • Inflammation

Hospitalization Burden by Age and Comorbidity in Adults With Recurrent Clostridioides difficile Infection: An Exploratory ECOSPOR III Analysis (ACG 2026) - " ECOSPOR III was a phase 3, randomized, double-blind trial of fecal microbiota spores, live-brpk vs placebo for prevention of rCDI. Adults with â¥3 CDI episodes in 12 months, toxin-positive CDI, and symptom resolution after 10â21 days of vancomycin or fidaxomicin were followed for 24 weeks... The ITT population included 182 patients (98.9% managed as outpatients); mean age was 65.6 years and mean age-adjusted CCI was 4.1â4.2 across treatment arms. Through week 24, 36 patients (19.8%) were admitted to the hospital for any reason, including 9 (4.9%) admitted for CDI recurrence. These patients accounted for 46 all-cause and 12 rCDI-related hospitalization events, with 3 patients each being hospitalized twice for CDI recurrence."

Clinical • Infectious Disease

Managing Refractory Immune Checkpoint Inhibitor-Induced Colitis With Oral Fecal Microbiota Transplantation: A Case Report (ACG 2026) - "We present a case of delayed-onset ICI colitis following prolonged pembrolizumab therapy, complicated by recurrent C.diff colonization, successfully managed with Vowst after failed multiple therapies...She received vancomycin (14 days) and nitazoxanide (7 days) without dramatic improvement...Vedolizumab was given, and a second Rebyota attempt failed due to high-volume diarrhea...Figure: Figure 2. Symptoms, laboratory exams, and treatment course including antibiotics, Rebyota and Vowst."

Case report • Checkpoint inhibition • Clinical • Breast Cancer • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Transplantation

Clinical Experience with Oral Fecal Microbiota Spores (Vowst®) in a Health System Specialty Pharmacy. (PubMed, Am J Health Syst Pharm) - "Implementation of an adapted HSSP FMS medication workflow resulted in medication access for more than half of patients and offers a practical, adaptable model for integrating high-cost microbiome therapies into specialty pharmacy practice."

Journal • Infectious Disease • Transplantation

In silico analysis of MALAT1 and H19 lncRNA interactions with the diabetes-related proteins ASK1 and YAP1. (PubMed, In Silico Pharmacol) - "Docking and simulations suggested MALAT1 binding to exposed ASK1 surfaces, while H19 was predicted to associate with YAP1 regions encompassing the TEAD-binding domain and conserved regulatory phosphorylation sites, including residues corresponding to Ser109, Ser127, and Thr119...These results identify structurally plausible RNA-protein interaction interfaces that overlap with known regulatory hotspots in YAP1. Overall, this work provides a framework for experimental validation of lncRNA-mediated regulation in diabetes-related signalling pathways."

Journal • Diabetes • Metabolic Disorders • MALAT1 • YAP1

Effectiveness of VOWST for Prevention of Recurrent Clostridioides difficile infection in a Predominantly Immunocompromised Cohort (IDWeek 2026) - No abstract available

Infectious Disease

Food and Drug Administration-Approved Fecal Microbiota-Based Therapies for Recurrent Clostridioides difficile Infection. (PubMed, Gastroenterol Clin North Am) - "Two Food and Drug Administration-approved donor-derived fecal microbiota-based products, fecal microbiota, live-jslm (Rebyota / RBL) and fecal microbiota spores, live-brpk (Vowst / VOS) reduce recurrence when administered after completion of standard antibiotics. We also discuss patient selection, timing after antibiotics, diagnostic considerations, and practical implementation. These therapies represent standardized, evidence-based approaches to restoring colonization resistance and preventing recurrent infection in appropriately selected adults."

Journal • Review • Infectious Disease • Transplantation

Post-Marketing Safety Signals of Microbiota-Based Live Biotherapeutic Products for Recurrent Clostridioides difficile Infection: A FAERS Pharmacovigilance Study. (PubMed, Am J Gastroenterol) - "FDA-approved LBPs demonstrate reassuring post-marketing safety profiles without transmitted infection signals. The extreme VOWST UTI signal is likely attributable to FDA-mandated expedited reporting obligations rather than a causal drug effect."

Adverse events • Journal • P4 data • Infectious Disease • Septic Shock • Transplantation • ROR1

Diving Deeper into the Platelet Phosphoproteome – Decoding Phosphorylation Signatures by Demographics (ISTH 2026) - "Results Preliminary data shows, that we are able to robustly assess several phosphorylation sites associated with the platelet activation/inhibition pathway, such as VASP Ser157, ENSA Ser109, and PDE3A Ser312...All samples have been acquired as a medical product and isolated according to good scientific practice (GSP). DOI*10.1016/j.rpth.2026.105240"

Cardiovascular • Thrombosis • PDE3A

AGA Clinical Practice Update on Management of Clostridioides difficile Infection in Adults: Expert Review. (PubMed, Clin Gastroenterol Hepatol) - "BEST PRACTICE ADVICE 5: Cholestyramine and other bile acid-binding agents should not be used as monotherapy or concurrently with oral vancomycin or fidaxomicin...BEST PRACTICE ADVICE 8: Fecal microbiota-based therapies (fecal microbiota spores, live-brpk, fecal microbiota, live-jslm, or conventional fecal microbiota transplant) should be offered after treatment of a second recurrence (third C difficile infection episode)...If a legitimate indication exists for their use, proton pump inhibitor discontinuation is not necessary. BEST PRACTICE ADVICE 14: Individuals with a history of C difficile infection should be specifically counseled to avoid unnecessary antibiotic therapy."

Clinical guideline • Journal • Critical care • Hepatology • Infectious Disease • Transplantation

Cost-effectiveness of Microbiota Restoration Therapies for Recurrent Clostridioides difficile Infection. (PubMed, Am J Gastroenterol) - "Earlier initiation of microbiota-based therapies after the first CDI recurrence provides greater health benefits at acceptable cost-effectiveness thresholds compared with delayed use, supporting earlier integration into rCDI treatment strategies. VOS-versus-RBL comparisons should be interpreted as exploratory indirect comparisons pending comparative real-world or head-to-head data."

HEOR • Journal • Infectious Disease

AGA Clinical Practice Update on Management of Clostridioides difficile Infection in Inflammatory Bowel Disease: Expert Review. (PubMed, Gastroenterology) - "BEST PRACTICE ADVICE 4: In patients with IBD who develop an initial episode of CDI, clinicians should preferentially use fidaxomicin or use vancomycin if fidaxomicin is unavailable or cost-prohibitive...BEST PRACTICE ADVICE 9: Clinicians may consider loperamide in patients with improving inflammation and infection but ongoing diarrhea. BEST PRACTICE ADVICE 10: Clinicians should offer microbiome-based therapies (eg, fecal microbiota, live-jslm, fecal microbiota spores, live-brpk, or unapproved fecal microbiota transplantation) to patients with IBD with at least 1 recurrence of CDI to prevent future infection. BEST PRACTICE ADVICE 11: In patients with IBD, clinicians should not advise probiotics for primary or secondary prevention of CDI. BEST PRACTICE ADVICE 12: In patients with IBD and a history of CDI who are receiving systemic antibiotics, clinicians may consider oral vancomycin prophylaxis as secondary prevention."

Clinical guideline • Journal • Crohn's disease • Cytomegalovirus Infection • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Pain • Septic Shock • Transplantation • Ulcerative Colitis

Angiotensin 1-7 Modulates the Dynamics and Activation of the Proto-Oncogene Mas Receptor. (PubMed, J Mol Recognit) - "We demonstrate that Ang 1-7 releases the inactive core lock (ARG245-TYR248) to engage a critical anchor cluster (SER109/PHE112)...These findings provide a structural rationale for the partial agonist profile of Ang 1-7 and offer a transformative mechanistic framework for therapeutic targeting of the ACE2/Ang 1-7/MasR axis. We propose that rational drug design need not aim for maximal receptor opening; instead, strategies focusing on peptidomimetics or positive allosteric modulators (PAMs) that stabilize this specific compact active state could selectively potentiate protective RAS signaling."

Journal • Oncology • ANGPT1

Structural properties of antioxidant peptides released from sweet apricot kernel protein with regulation by ultrasound-assisted enzymolysis. (PubMed, Ultrason Sonochem) - "Molecular docking simulation indicates that the differential active pockets of Alcalase, Flavourzyme, Neutrase and Papain in traditional enzymolysis are Asp30-Gly102-Pro108-Ser109-Ser116-Tyr119-Gly131-Thr139-Asn144-Arg150-Lys151-Asn152-Asp153-Glu163-Asn166-Lys281-Ser324-Ser326-Pro425-Thr427, Gln91-Lys99-Ser248-Lys255-Val285-Glu287-Ala299-Cys301-Tyr325-Asn337-Gln359-Arg362, Ser49-Tyr107-Ser119-Val140-Asn152-Tyr194-Lys220-Arg221-Asn228 and Gly23-Arg111-Gln128-Asn155-Tyr208-Pro209 residues, respectively. Similarly, the correspondingly differential active pockets for ultrasound-assisted enzymolysis are Gly164-Ala172-Tyr195-Phe240-Asn383-Arg396, BMA3-Man4-Asp27-Tyr29-Glu43-Lys54-Glu61-Lys118-Ser153-Asp183-Ser186-Asp286-Asp298-Thr302-Thr305-Asp307-Ser339-Asp346, Glu167-Ser223 and Asp6-Gly20-Gys22-Arg58-Gln92-Gln114-Ala126-Lys156 residues, respectively. As a result, this investigation proves that ultrasound selectively increases cleavage sites of enzymolysis and the targeted..."

Journal • PLK4

Emerging Therapeutic Approaches for Modulating the Intestinal Microbiota. (PubMed, Pharmaceutics) - "BCT offers a standardized alternative to donor-derived material, with early clinical successes such as FDA-approved SER-109. Phage therapy and OMVs represent promising frontiers, offering targeted microbial modulation and interactions with the immune system, although clinical data remain limited. Emerging gut microbiota modulation strategies offer new perspectives for precision medicine and could transform the prevention and treatment of many diseases, but further studies are needed to ensure their safety, standardization, and clinical application."

Journal • Review • Cardiovascular • CNS Disorders • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Mental Retardation • Obesity • Psychiatry • Transplantation

Clinical applications of live biotherapeutics: Current trends and future prospects. (PubMed, Prog Mol Biol Transl Sci) - "The most important advancement is in the infectious disease domain, where fecal microbiota transplantation validated ecological restoration for recurrent Clostridioides difficile infection and paved the way for the first approved LBPs (REBYOTA® and VOWST™/SER-109). Translation from benchside to bedside, however, is fraught with hurdles-variable patient response, manufacturing consistency, safety standards, cost, and ethics-exacerbated by heterogeneous global regulations, underscoring the need for harmonization. Precision microbial consortia, programmable "living medicines," and biohybrid formulations could extend LBPs into broader indications and global health, shifting practice toward an ecological model of therapeutics."

Journal • Review • Allergy • Immunology • Infectious Disease • Metabolic Disorders • Oncology • Transplantation

Live biotherapeutics in the clinic: Regulatory pathways, market dynamics, and future trends. (PubMed, Prog Mol Biol Transl Sci) - "The approvals of Rebyota and Vowst for recurrent Clostridioides difficile infection mark a pivotal milestone, establishing LBPs as a new therapeutic class. Progress, however, is tempered by manufacturing complexity, regulatory burden, reimbursement challenges, public perception, and incomplete mechanistic understanding. Despite these hurdles, the future is compelling, marked by expanding indications, engineered strains, standardized consortia, scalable manufacturing, regulatory harmonization, and accelerating investment."

Journal • Review • Infectious Disease • Metabolic Disorders • Oncology

Fecal Microbiota Transplantation in 2025: Two Steps Forward, One Step Back. (PubMed, Curr Gastroenterol Rep) - "After decades of steady progress, the U.S. Food and Drug Administration (FDA) approved the first FMT-based therapies: fecal microbiota, live-jslm and fecal microbiota spores, live-brpk-in 2022 and 2023, respectively. Although first reported almost seventy years ago, extensive efforts over the last two decades have placed FMT in routine algorithms for many patients with CDI. While understanding of the intestinal microbiome's role in other gastrointestinal conditions is expanding, and FMT may modulate these pathways, additional evidence is needed before FMT becomes routine outside CDI."

Journal • Review • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Transplantation

The impact of an oral purified microbiome therapeutic on the gastrointestinal microbiome. (PubMed, Nat Med) - P2, P3 | "VOWST (VOWST oral spores, VOS; fecal microbiota spores, live-brpk, formerly SER-109) is an FDA-approved, orally administered consortium of purified Firmicutes spores developed to prevent recurrent Clostridioides difficile infection (CDI)...These findings on the pharmacology of VOS underscore the importance of rapidly restoring key protective functions of the microbiome in patients with recurrent CDI to achieve durable prevention of recurrence, as observed in the phase 3 study; they also highlight the need to include the microbiome in the clinical management of CDI. ClinicalTrials.gov registrations: NCT02437487 and NCT03183128 ."

Journal • Infectious Disease

Diagnosis and Management of C. difficile. (PubMed, Am J Gastroenterol) - "Treatment paradigms are discussed across the spectrum of disease severity, with vancomycin and fidaxomicin as first-line therapies and the diminishing role of metronidazole. For recurrent CDI, newer fecal microbiota-based therapies, including Fecal Microbiota, live-jslm (Rebyota, RBL) and Fecal Microbiota Spores, live-brpk (Vowst, VOS), are reviewed. The role of conventional fecal microbiota transplantation (FMT), particularly in fulminant CDI, is also addressed, including challenges resulting from FDA policies around stool bank material. We aim to clarify diagnostic and therapeutic approaches and optimize care for patients with CDI."

Journal • Infectious Disease • Transplantation

Comparison of the Efficacy and Safety of Live Fecal Microbiota Therapeutics for Recurrent Clostridioides difficile Infection (CDI): Matching-Adjusted Indirect Treatment Comparison in Patients With ≥1 CDI Recurrence (ACG 2025) - "The orally administered fecal microbiota spores, live-brpk (VOS) and rectally administered fecal microbiota, live-jslm (RBL), with different compositions, are both FDA-approved for any patients with rCDI. Of the 33 publications identified in the SLR, six, reporting on two distinct studies including patients with ≥1 recurrent episode were deemed eligible for the MAIC. VOS was significantly more efficacious than RBL in preventing rCDI at 8 weeks (odds ratio [OR]; 9.23 [95% confidence interval (CI): 4.24, 20.08]). The time to recurrence over time was significantly lower with VOS compared with RBL (hazard ratio; 0.19 [95% CI; 0.10, 0.33])."

Clinical • Infectious Disease

Efficacy of Fecal Microbiota Transplant for Prevention of Recurrent CDI in Patients Diagnosed With Cancer (ACG 2025) - "Vancomycin and fidaxomicin were the most frequently used antibiotics, and 18.8% received bezlotoxumab.Colonoscopy-delivered FMT was the most common intervention (68.1%), followed by Rebyota (17.4%) and VOWST (7.2%); combination strategies were used in 7.2%. A total of 69 patients with a history of CDI or rCDI were included. Hematologic malignancies were the most common cancer type (29.6%), and nearly half had stage III–IV disease. At the time of their most recent CDI episode, 55% were receiving active cancer therapy."

Clinical • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Infectious Disease • Oncology • Transplantation

Microbiota-Based Therapies for Recurrent Clostridium difficile Infection: A Systematic Review of Their Efficacy and Safety. (PubMed, Cureus) - "Donor FMT outperformed autologous FMT (90.9% vs. 62.5%, p = 0.042) and standard therapies (71% resolution vs. 33% fidaxomicin/19% vancomycin, p < 0.01). Donor-derived interventions and pharmaceutical-grade products (SER-109, RBX2660) represent promising alternatives to traditional antibiotics, particularly in recurrent or refractory cases. Future research should aim to standardize protocols and include more high-risk populations."

Journal • Review • Infectious Disease • Transplantation