The goal of this clinical trial is to find out if a gut cleaning using Rifaximin works as well as the usual treatment with Neomycin and Metronidazole to prevent infections after colon surgery. The study includes adult patients who will have colon surgery.
The main question it aims to answer are:
-Does the Rifaximin treatment prevent surgical site infections as well as the Neomycin/Metronidazole treatment?
Other things the study will look at:
* How often infections happen, stratified on how deep they are, the type of surgery the patients got, or if bowel cleaning was done before surgery.
* How many people will die after surgery
* How long people stay in hospital
Participants will:
* Take either Rifaximin or Neomycin/Metronidazole one day before surgery to clean their gut
* Keep a diary until the surgery to record medication intake and any side effects
* Be contacted by phone 30 days after surgery to ask about their condition and any side effects,

Start Date01 Jun 2026

Sponsor / Collaborator

Universität Luzern

NCT05408910

/ WithdrawnPhase 2/3IIT

Rifaximin for Treatment of Bloating in Children and Adults With Cystic Fibrosis

Gastrointestinal symptoms are commonly reported in as much as 65% of people with CF even independent of pancreatic enzyme replacement therapy (PERT) and the most frequent of these symptoms are bloating/distension, flatulence, abdominal pain and bowel habit changes. An alteration in the intestinal microbiome due to intestinal dysmotility, inflammation or other changes including pH changes in the intestine related to CFTR gene mutation may cause intestinal dysbiosis leading to a bacterial overgrowth in the proximal small intestine which may explain some of the findings of distension and bloating in CF.
Our small pilot study aims to investigate use of the only FDA-approved antibiotic, rifaximin for a GI syndrome- IBS, to treat bloating and global GI symptoms in CF patients with bloating and distension. Our goal is to recruit patients >12 years and age/sex matched into rifaximin and placebo arms with total of 100 recruited subjects recruited.

Start Date01 Jul 2025

Sponsor / Collaborator

Wake Forest School of Medicine

[+3]

NCT06483737

/ RecruitingNot ApplicableIIT

Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE): an Invesitgator-initiated, Open-label, Multicenter, Randomized Controlled Trial

Hepatic encephalopathy (HE), a severe complication of decompensated cirrhosis, is characterized as neurocognitive dysfunction. Emerging evidence suggests the potential role of human albumin infusion for the treatment of HE, but its optimal dosage remains undefined. Therefore, the investigators planned a randomized controlled trial (RCT) to compare the efficacy of human albumin infusion at different dosages in in patients with liver cirrhosis and overt HE.

Start Date24 Jun 2025

Sponsor / Collaborator

The General Hospital of Shenyang Military Region

100 Clinical Results associated with Rifaximin

100 Translational Medicine associated with Rifaximin

100 Patents (Medical) associated with Rifaximin

1,700

Literatures (Medical) associated with Rifaximin

31 Dec 2025·Virulence

Differences in virulence and drug resistance between Clostridioides difficile ST37 and ST1 isolates

Article

Author: Qin, Pu ; Qiang, Cuixin ; Zhang, Huimin ; Wang, Weigang ; Li, Zhirong ; Zhao, Jianhong ; Yang, Yaxuan ; Yang, Jing ; Yang, Huimin ; Zhao, Min ; Niu, Yanan ; Ouyang, Zirou ; Zhao, Jiafeng

One of the most common hospital-acquired infections is caused by toxigenic Clostridioides difficile. Although C. difficile ST37 only produces a functional toxin B, it causes disease as severe as that caused by hypervirulent ST1. We aim to compare the differences in virulence and drug resistance between ST37 and ST1 isolates. We conducted whole-genome sequencing on ST37 and ST1 isolates, analyzing their type-specific genes, and the distribution and mutation of genes related to virulence and antibiotic resistance. We compared the in vitro virulence-related phenotypes of ST37 and ST1 isolates, including: TcdB concentration, number of spores formed, aggregation rate, biofilm formation, swimming diameter in semi-solid medium, motility diameter on the surface of solid medium, and their resistance to 14 CDI-related antibiotics. We detected 4 ST37-specific genes related to adherence, including lytC, cbpA, CD3246, and srtB. We detected 97 virulence-related genes in ST37 isolates that exhibit genomic differences compared to ST1. ST37 isolates showed increased aggregation, biofilm formation, and surface motility compared to ST1 in vitro. Chloramphenicol resistance gene catQ and tetracycline resistance gene tetM are present in ST37 but absent in ST1 strains. The resistance rates of ST37 to chloramphenicol and tetracycline were 45.4% and 81.8%, respectively, whereas ST1 isolates were sensitive to both antibiotics. ST1 was more resistant to rifaximin than ST37. ST37 isolates showed stronger aggregation, biofilm formation and surface motility, and had higher resistance rates to chloramphenicol and tetracycline. ST1 isolates showed stronger ability to produce toxin and sporulation, and was highly resistant to rifaximin.

01 Dec 2025·Current Neurology and Neuroscience Reports

Hepatic Encephalopathy: Current Thoughts on Pathophysiology and Management

Review

Author: Chakravarty, Ambar ; Pan, Kausik ; Sen, Barun Kumar

PURPOSE OF REVIEW:

This review highlights the causes, types and clinical staging of hepatic encephalopathy (HE). Current concepts on the probable pathogenetic mechanisms and currently practiced therapeutic options are discussed.

RECENT FINDINGS:

HE may be covert and overt. Also known as minimal HE. Covert HE, where there are behavioral abnormalities and impairment in activities of daily living with intact sensorium. The pathophysiology of HE remains poorly understood. There is disturbance of the urea cycle due to liver disease leading to increased production of ammonia. The ammonium ion enters the astrocytes along with glutamate (converted to glutamine by ammonia) and myo-inositol, thereby increasing the osmolality of the astrocytic cytoplasm. This osmotic gradient results in accumulation of water inside the astrocytes resulting in cerebral edema and increase in brain volume. Additionally, current research has noted the role of cerebral oxidative/nitrosative stress and the synergistic effects of increased cerebral ammonia and alteration in neurotransmitters, neurometabolites, and cortical excitability due to systemic inflammation. In advanced liver disease with systemic infection or inflammation, neuroinflammatory processes play significant role in the development of HE. Inflammatory cytokines like TNF-α, IL-6, IL-17 in presence of hyperammonemia have been found to induce neurotoxicity of ammonia by passing through the blood brain barrier and causing enlarged/swollen pale astrocytes, resulting in HE. Disrupted enterohepatic circulation in end stage liver disease also causes elevation of bile acids which induces neuroinflammation. Manganese and zinc play as co-factors of enzymatic reaction. These metal deposition causes multiple psychomotor symptoms observed in HE. The gut environment has a major impact on brain function in patients with HE. Toxins such as ammonia and inflammatory cytokines produced by this impaired intestinal flora access the circulation through porto-systemic anastomoses and exacerbate or precipitate HE. Finally, as a result of recurrent cerebral edema from astrocytic dysfunction and neuroinflammation, permanent neurodegeneration occurs with cognitive decline and motor disturbances, especially parkinsonian features and gait disturbances. This is the stage of chronic hepatic encephalopathy. Currently L-ornithine L-aspartate (LOLA) is being used to lower the ammonia level by stimulating the urea cycle. HE comprises a broad spectrum of neurological and/or psychiatric abnormalities caused by hepatic insufficiency and/or portal-systemic shunting in the absence of any other causes of brain dysfunction. HE may be caused or precipitated by several factors like infections, intoxications and drugs. The encephalopathic features may be covert or overt. The pathogenetic mechanisms for HE may be different. In the presence of liver disease, HE primarily results from disturbed urea cycle with hyperammonemia causing astrocytic swelling and cerebral edema. Porto-systemic anastomoses with intact liver function can cause HE by allowing ammonia and other toxins produced by the gut microbial flora and allowing these to bypass detoxification by the liver and exposing the brain to their harmful effects. Principles of therapy are twofold. First protecting the liver and the brain from gut generated ammonia and other toxins by ensuring smooth bowel function and avoiding stagnation with the use of osmotic laxatives like lactulose or lactitol and also reducing the gut microbial load with use of anti-bacterials/bacteriophages like neomycin and rifaximin along with metronidazole. Second, reducing the already generated cerebral edema by use of mannitol and appropriate ventilatory support. Currently L-ornithine L-aspartate (LOLA) is being used to reduce the ammonia load to the liver. LOLA is a stable compound formed from two amino acids. L-ornithine plays a crucial role in stimulating the urea cycle, leading to a reduction in ammonia levels. Both L-ornithine and L-aspartate serve as substrates for the enzyme glutamate transaminase, and their administration results in elevated glutamate concentrations. Ammonia is subsequently utilized in the conversion of glutamate to glutamine through the action of glutamine synthetase. Finally in resistant cases the use of liver transplant needs to be considered. Alternatively extracorporeal liver assist devices may be used like Molecular Adsorbent Recirculating System (MARS) or Single-Pass Albumin Dialysis (SPAD).

01 Oct 2025·JOURNAL OF HEPATOLOGY

Validation and expansion of Baveno VII recompensation criteria in patients with cirrhosis and curable liver disease

Article

Author: Zilio, Gianluca ; Gambino, Carmine Gabriele ; Caraceni, Paolo ; Incicco, Simone ; Accetta, Antonio ; Calvino, Valeria ; Zaccherini, Giacomo ; Angeli, Paolo ; Iannone, Giulia ; Baldassarre, Maurizio ; Carrello, Daniele ; Barone, Anna ; Piano, Salvatore ; Pompili, Enrico ; Tonon, Marta ; Zeni, Nicola ; Gagliardi, Roberta

BACKGROUND & AIMS:

The Baveno VII group recently proposed criteria to define recompensation in patients with decompensated cirrhosis achieving etiological cure. However, the incidence, predictors and clinical significance of recompensation are poorly understood. The aim of this study was to evaluate the incidence and prognostic impact of recompensation in patients with decompensated cirrhosis.

METHODS:

Outpatients with cirrhosis and curable etiologies (alcohol, HCV, HBV) were consecutively included and followed up. Recompensation was defined according to Baveno VII criteria. Additionally, expanded recompensation criteria were evaluated for patients on low-dose diuretics and/or lactulose/rifaximin for ≥12 months. In 160 patients, inflammatory cytokines (IL-6, IL-1β, IL-10) were measured in serum samples. An external cohort was used to validate study findings.

RESULTS:

Out of 525 outpatients with decompensated cirrhosis, 298 received effective etiological treatment and 21 (7%) achieved recompensation (Baveno VII criteria), while 112 patients achieved expanded recompensation criteria (37.6%). MELD score (subdistribution hazard ratio [sHR] 0.89; p <0.001), BMI (sHR 0.93; p = 0.020), hemoglobin (sHR 1.14; p = 0.010) and further decompensation (sHR 0.50; p = 0.001) were independent predictors of recompensation. In multivariable analysis, mortality risk was not significantly different between patients achieving recompensation and compensated patients (HR 0.97; p = 0.947), while decompensated patients had the highest mortality risk (HR 4.96; p <0.001). Mortality risk was not significantly different between patients meeting expanded recompensation criteria and Baveno VII criteria (HR 0.97; p = 0.938). Serum IL-6, IL-1β and IL-10 were significantly higher in decompensated patients than in compensated and recompensated patients.

CONCLUSION:

Baveno VII criteria identify patients with cirrhosis and a good prognosis, but fewer than 10% of decompensated patients achieve recompensation. Expanding these criteria to include patients receiving minimal decompensation treatment identifies those with similarly low mortality risk.

IMPACT AND IMPLICATIONS:

In recent years, growing evidence has shown that achieving an etiological cure can significantly improve the prognosis of patients with decompensated cirrhosis, leading to the concept of recompensation. The Baveno VII group recently proposed criteria to define recompensation; however, data on the clinical impact of this state remain limited. In this study we evaluated Baveno VII criteria and developed and validated expanded Baveno VII criteria for recompensation. Our findings demonstrate that recompensation is associated with improved survival, reduced hyperdynamic circulation and decreased systemic inflammation in outpatients with decompensated cirrhosis. These results are valuable for hepatologists and researchers aiming to refine patient management strategies and risk stratification in cirrhosis care.

103

News (Medical) associated with Rifaximin

30 Jul 2025

·ir.bauschhealth.com

Bausch Health Announces Second Quarter 2025 Results

Bausch Health Announces Second Quarter 2025 Results Second Quarter Consolidated Revenues of $2.53 billion, up 5% on a Reported basis and 4% on an Organic (non-GAAP)1 basis over the prior year period GAAP Net Income Attributable to Bausch Health Companies of $148 million and GAAP Net Income of $128 million Consolidated Adjusted EBITDA Attributable to Bausch Health Companies (non-GAAP)1 of $842 million, up 6% on a Reported basis over the prior year period BAUSCH HEALTH EXCLUDING BAUSCH + LOMB SECOND QUARTER 2025 RESULTS Delivered ninth consecutive quarter of year-over-year Revenue and Adjusted EBITDA (non-GAAP)1 growth, with 5% both Reported and Organic (non-GAAP)1 Revenue growth, and 10% Adjusted EBITDA (non-GAAP)1 growth Announced upcoming repayment of approximately $900 million dollars of debt using cash on hand after quarter-end Entered into an agreement to acquire DURECT Corporation in July, which if all closing conditions are satisfied and the acquisition closes, will enable Bausch Health to use its hepatology expertise to seek to gain approvals and commercialize DURECT's main treatment for alcohol-induced hepatitis Reaffirming full-year 2025 Revenue, Adjusted EBITDA (non-GAAP)1, and Adjusted Cash Flow from Operations (non-GAAP)1 guidance LAVAL, QC, July 30, 2025 – Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) ("Bausch Health" or the "Company" or "we" or "our") today announced its second quarter 2025 financial results and other key updates from the quarter. "In the second quarter, we achieved our ninth consecutive quarter of year-over-year growth in Revenue and Adjusted EBITDA for Bausch Health, excluding Bausch + Lomb. This consistent performance highlights our operational excellence and the strength of our diverse portfolio across therapeutic areas and geographies. As we look toward the second half of 2025, we remain focused on executing against our strategic priorities to drive continued growth and unlock long-term value for our shareholders," said Thomas J. Appio, Chief Executive Officer, Bausch Health. Second Quarter 2025 Revenue Performance Total consolidated reported revenues were $2.53 billion for the second quarter of 2025, compared with $2.40 billion in the second quarter of 2024, an increase of $127 million, or 5%. Excluding the impact of foreign exchange of $21 million, acquisitions of $6 million, and divestitures and discontinuations which negatively impacted the prior year by $2 million, revenue increased 4% on an organic1 basis compared with the second quarter of 2024. 1 This is a non-GAAP measure or a non-GAAP ratio. For further information on non-GAAP measures and non-GAAP ratios, please refer to the "Non-GAAP Information" section of this news release. Please also refer to tables at the end of this news release for a reconciliation of this and other non-GAAP measures and ratios to the most directly comparable GAAP measure. Reported revenues by segment were as follows: Three Months Ended June 30, Reported Change Change at Constant Currency1 (Non-GAAP) Change in Organic Revenue1 (Non-GAAP) (in millions) 2025 2024 Amount Pct. Total Bausch Health Revenues $2,530 $2,403 $127 5% 4% 4% Bausch Health (excl. B+L) $1,252 $1,187 $65 5% 5% 5% Salix segment $627 $558 $69 12% 12% 12% International segment $278 $276 $2 1% — 1% Solta Medical segment $128 $102 $26 25% 26% 26% Diversified segment $219 $251 ($32) (13%) (13%) (13%) Bausch + Lomb segment $1,278 $1,216 $62 5% 3% 3% Salix Segment Salix segment reported revenues were $627 million for the second quarter of 2025, compared with $558 million for the second quarter of 2024, an increase of $69 million, or 12%. Excluding divestitures and discontinuations, which negatively impacted the prior year by $4 million, segment revenues increased 12% on an organic1 basis compared with the second quarter of 2024. Xifaxan® was the primary driver of segment growth, with 10% revenue growth in the second quarter of 2025 compared with the prior year period. International Segment International segment reported revenues were $278 million for the second quarter of 2025, compared with $276 million for the second quarter of 2024, an increase of $2 million, or 1%. Excluding the impact of foreign exchange of $1 million and divestitures and discontinuations of $2 million, segment revenues increased 1% on an organic1 basis compared with the second quarter of 2024, led by growth in Canada and EMEA. Solta Medical Segment Solta Medical segment reported revenues were $128 million for the second quarter of 2025, compared with $102 million in the second quarter of 2024, an increase of $26 million, or 25%. Excluding the impact of foreign exchange of $1 million, segment revenues increased on an organic1 basis by 26% compared with the second quarter of 2024, led by growth in South Korea. Diversified Segment Diversified segment reported revenues were $219 million for the second quarter of 2025, compared with $251 million for the second quarter of 2024, a decrease of $32 million, or 13%. Excluding divestitures and discontinuations, which negatively impacted the prior year by $2 million, segment revenues decreased 13% on an organic1 basis compared with the second quarter of 2024. Bausch + Lomb Segment Bausch + Lomb segment reported revenues were $1.28 billion for the second quarter of 2025, compared with $1.22 billion for the second quarter of 2024, an increase of $62 million, or 5%. Excluding the impact of foreign exchange of $21 million, acquisitions of $6 million and divestitures and discontinuations of $2 million, segment revenues increased 3% on an organic1 basis compared with the second quarter of 2024. Read More View original release here: https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/bausch-health-announces-second-quarter-2025-results-1054773.

AcquisitionFinancial Statement

29 Jul 2025

·pipelinereview.com

Bausch Health to Acquire DURECT Corporation, Strengthening Commitment to Developing Innovative Solutions for Patients with Liver Disease

LAVAL, Canada and CUPERTINO, CA, USA I July 29, 2025 I Bausch Health Companies Inc. (NYSE: BHC ) (TSX: BHC), a global, diversified pharmaceutical company, and DURECT Corporation (NASDAQ: DRRX ) today announced a definitive agreement under which Bausch Health will indirectly acquire DURECT Corporation, including a novel therapeutic molecule, larsucosterol, which can harness the power of epigenetic modulation. Larsucosterol, an endogenous sulfated oxysterol and an epigenetic modulator, has demonstrated promising results for the treatment of alcoholic hepatitis (AH) in Phase 2 trials. Bausch Health’s hepatology development and commercial capabilities are well-suited to support the clinical development and potential commercialization of larsucosterol. AH is a life-threatening form of alcohol-associated liver disease (ALD), which can occur in individuals who chronically misuse alcohol. It is characterized by severe inflammation and destruction of liver tissue (i.e., necrosis). AH accounted for roughly 164,000 hospital admissions in the U.S. in 2021. There is currently no Food and Drug Administration (FDA) or European Medicines Agency (EMA) approved treatment for AH, and novel therapeutic strategies are needed to improve patient survival. “This announcement is fundamental progress on our Strategic Priority – Innovation, which is to intensify focus and operating rigor behind R&D and business development and demonstrates our commitment to hepatology and finding new ways to address unmet medical needs, living our purpose of enriching lives through our relentless drive to deliver better health outcomes for patients.” said Thomas J. Appio, Chief Executive Officer, Bausch Health. “There is a significant unmet need in the treatment of patients with AH given the high mortality rate and that there are no currently approved treatments. We are very excited to add larsucosterol, an asset which has FDA Breakthrough Therapy Designation, to our pipeline, particularly as it builds on our existing expertise within the hepatology space. It is complementary to our ongoing Phase 3 program of soluble solid dispersion of rifaximin (rifaximin SSD) being studied in cirrhotic patients globally,” stated Jonathan Sadeh M.D., M.Sc. as Executive Vice President, Chief Medical Officer and Head of R&D at Bausch Health. “AH, by our estimates, is responsible for about 100 deaths per day in the US and billions of dollars in healthcare costs,” stated James E. Brown, D.V.M., President and CEO of DURECT. “Since we reported results from our Phase 2b AHFIRM clinical trial for larsucosterol in AH, our primary focus has been advancing larsucosterol towards the completion of clinical development. We chose this transaction with Bausch Health because we believe it provides significant value for our stakeholders, both immediately and in the long term, should larsucosterol be approved and achieve commercial success. We view Bausch Health as the right partner to advance larsucosterol due to their expertise in hepatology, commercial success with Xifaxan and experienced development team. We look forward to the potential impact larsucosterol could have for patients with AH and the medical community that cares for them. Thank you to our team at DURECT and our partners that have helped advance larsucosterol to this point.” A registrational Phase 3 program to evaluate the safety and efficacy of larsucosterol for the treatment of patients with severe AH is being planned. The trial will be a randomized, double-blind, placebo-controlled, multi-center study. The primary endpoint will be 90-day survival. The trial design will incorporate feedback received from the FDA during a Type B meeting under Breakthrough Therapy Designation as well as learnings from the prior Phase 2b AHFIRM trial in AH. The acquisition of the clinical development program for larsucosterol in AH compliments the ongoing Bausch Health RED-C clinical program which is designed to assess the efficacy of a next generation therapeutic, rifaximin SSD, to delay onset of first overt hepatic encephalopathy (OHE) hospitalization and all-cause mortality. There are no medications globally approved for the primary prophylaxis and delay in decompensation to first episode of OHE in cirrhosis. Patient enrollment in two global Phase 3, randomized, double-blind, placebo-controlled studies is now complete with efficacy and safety results expected to be announced in early 2026. “The addition of larsucosterol to our pipeline is a strategic fit with our focus in hepatology and underscores our continued dedication to exploring and identifying new treatments for individuals who are suffering with liver disease and its complications,” stated Aimee Lenar, Executive Vice President of US Pharma at Bausch Health. “We are excited to continue investment in bringing these breakthrough options to market, not just in the US, but also globally.” Transaction Terms and Financial Considerations Under the terms of the definitive agreement, a wholly owned subsidiary of Bausch Health will commence a tender offer for all outstanding shares of DURECT Corporation. Under the terms of the definitive agreement, Bausch Health will pay $1.75 per share in an all-cash transaction for an upfront consideration of approximately $63 million at closing, with the potential for two additional net sales milestone payments of up to $350 million in the aggregate (subject to certain adjustments in respect of a retention plan) if the milestone is achieved before the earlier of the 10 year anniversary of the first commercial sale in the United States and December 31, 2045. The purchase price payable at closing represents a premium of approximately 191% to the 30-day volume-weighted average trading price of DURECT’s common stock ended on July 28, 2025, the last trading day before the announcement of the transaction. This upfront consideration represents a premium of approximately 217% to the trading price of DURECT’s common stock ended on July 28, 2025. The transaction is conditioned on a majority of the outstanding shares of DURECT Corporation’s common stock being tendered into the tender offer and not withdrawn, as well as other customary closing conditions. The transaction is expected to close in the third quarter of 2025. Assuming the closing of the tender offer, Bausch Health will acquire any shares of DURECT not tendered into the tender offer through a merger of a wholly owned subsidiary with and into DURECT for the same per share consideration payable in the tender offer. Advisors Centerview Partners LLC is serving as exclusive financial advisor and Sullivan & Cromwell LLP is serving as legal advisor to Bausch Health. Locust Walk is serving as exclusive financial advisor and Orrick, Herington and Sutcliffe LLP is serving as legal advisor to DURECT. About Bausch Health Bausch Health Companies Inc. (NYSE: BHC ) (TSX: BHC), is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. Our gastroenterology business, Salix Pharmaceuticals, is one of the largest specialty pharmaceutical businesses in the world and has licensed, developed and marketed innovative products for the treatment of gastrointestinal diseases for more than 30 years. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn. About DURECT Corporation DURECT Corporation (Nasdaq: DRRX ) is a late-stage biopharmaceutical company pioneering the development of epigenetic therapies that target dysregulated DNA methylation to transform the treatment of serious and life-threatening conditions, including acute organ injury. Larsucosterol, DURECT’s lead drug candidate, binds to and inhibits the activity of DNA methyltransferases, epigenetic enzymes that are elevated and associated with hypermethylation found in AH patients. Larsucosterol is in clinical development for the potential treatment of AH, for which the FDA has granted a Fast Track and a Breakthrough Therapy designation; MASH is also being explored. For more information about DURECT, please visit www.durect.com and follow us on X (formerly Twitter) at https://x.com/DURECTCorp . SOURCE : Durect

Phase 2Clinical ResultPhase 3Breakthrough Therapy

29 Jul 2025

·www.fiercebiotech.com

Bausch Health bags phase 3-ready liver prospect in $63M Durect buyout

Larsucosterol has a shot at becoming the first approved therapy for the liver disease.\n Bausch Health has struck a deal to buy Durect for $63 million upfront, landing a phase 3-ready liver disease candidate that the companies believe has blockbuster potential.Durect reported top-line data from a phase 2b trial in alcohol-associated hepatitis late in 2023. The study found DNMT modulator larsucosterol was no better than placebo on the primary endpoint of mortality or transplant at 90 days. While Durect argued secondary endpoint data supported further development, investors sent the stock into a sustained slump and the company’s cash pile fell below $10 million.Bausch Health came to the rescue Tuesday. The company has agreed to pay a premium of more than 200% over Durect’s closing price Monday, but that still amounts to a small upfront outlay.The value of the deal will however swell if larsucosterol lives up to Durect’s blockbuster vision for the molecule. Bausch Health has agreed to pay $100 million if sales top $500 million in a calendar year. If annual sales exceed $1 billion, Bausch Health will pay a further $250 million. The contingent value rights agreement pushes the total potential value of the deal above $400 million. Durect has estimated (PDF) the peak sales potential of larsucosterol exceeds $1 billion in the U.S. alone, but it has struggled to drum up investor enthusiasm since the phase 2b failed. The company has released subgroup analyses on regional differences in the patient population to make the case for larsucosterol. Encouraged by the findings, Durect began preparing to start a two-year phase 3 trial this year.With Bausch Health funding the phase 3, larsucosterol has a shot at becoming the first approved therapy for the liver disease. Aldeyra Therapeutics, Alfasigma’s Intercept Pharmaceuticals and Yale University are enrolling patients in phase 2 trials. Nterica Bio is gearing up to start a phase 1 trial. Surrozen dropped out of the race in March.Based on the timeline Durect provided in May, Bausch Health could have top-line data from the phase 3 larsucosterol trial in 2027. Durect has said results from a single pivotal trial will be enough to support a filing for FDA approval.The timeline positions larsucosterol to support Bausch Health’s preparations for the loss of exclusivity on Xifaxan. Bausch Health is fighting generics manufacturers in the courts but expects to lose exclusivity in 2028. Larsucosterol forms part of a two-pronged response to the problem, slotting in alongside a soluble solid dispersion of rifaximin that is on course for a phase 3 readout in cirrhotic patients early next year.

Phase 2Phase 3AcquisitionClinical ResultClinical Trial Failure

100 Deals associated with Rifaximin

External Link

KEGG	Wiki	ATC	Drug Bank
D02554	Rifaximin	D06AX11 A07AA11	DB01220

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hyperammonemia	Japan	ASKA Pharmaceutical Co., Ltd.	28 Sep 2016
Irritable bowel syndrome with diarrhea	United States	Salix Pharmaceuticals, Inc.	27 May 2015
Hepatic Encephalopathy	Australia	Norgine Pty Ltd.	17 May 2012
Turista	United States	Salix Pharmaceuticals, Inc.	25 May 2004
Diarrhea	China	Alfa Wassermann SpA	23 Dec 2002
Irritable Bowel Syndrome	China	Alfa Wassermann SpA	23 Dec 2002

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Diverticulitis	Phase 3	France	Alfasigma SpA	02 Jul 2018
Diverticulitis	Phase 3	Germany	Alfasigma SpA	02 Jul 2018
Diverticulitis	Phase 3	Italy	Alfasigma SpA	02 Jul 2018
Diverticulitis	Phase 3	Netherlands	Alfasigma SpA	02 Jul 2018
Diverticulitis	Phase 3	Spain	Alfasigma SpA	02 Jul 2018
Diverticulitis	Phase 3	United Kingdom	Alfasigma SpA	02 Jul 2018
Ascites	Phase 3	France	Alfasigma SpA	05 Jun 2018
Fibrosis	Phase 3	France	Alfasigma SpA	05 Jun 2018
Spontaneous bacterial peritonitis	Phase 3	France	Alfasigma SpA	05 Jun 2018
Crohn Disease	Phase 3	United States	Bausch Health Americas, Inc.	21 Aug 2014

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04249622 (CTgov)	Phase 2	HER2 Positive Breast Cancer	20	Questionnaire Administration+Rifaximin (Arm I (Rifaximin, Pertuzumab-based Chemotherapy))	cgslbduukp = lgnjkoyqzy zocxttspwv (zegdikdtrk, aebodzrche - sdfymkjhgk) View more	-	07 Aug 2025
				Questionnaire Administration (Arm II (Pertuzumab-based Chemotherapy))	wlzcezwugd = kjsvqcouri dpvwwkkikm (yoetknfxjt, zxagdfcuuc - xgidtrsnxd) View more
Pubmed \| J Hepatol	Not Applicable	-	152	Rifaximin 550 mg BID	fkjdkzipll(flgjyynkjr) = xqpfjzvoie kdyqduferv (mqwpdacduc, 43.5 - 67.8) View more	Negative	01 Jul 2025
				Placebo BID	fkjdkzipll(flgjyynkjr) = bsiogpoqge kdyqduferv (mqwpdacduc, 56.2 - 78.7) View more
Company_Website Manual	Not Applicable	Hepatic Encephalopathy	-	Xifaxan	uadqscokkx(oekndlrqvo): P-Value = <0.05	Positive	06 May 2025
				lactulose
NCT03219528 (CTgov)	Phase 4	Irritable Bowel Syndrome	74	Rifaximin 550 MG (Rifaximin)	depnnjvsez(amlyfjqzfz) = auuwowreiq bfcbkjyktt (gtnbkxijut, 1.8) View more	-	27 Apr 2025
				Low FODMAP Diet (Low FODMAP Group)	depnnjvsez(amlyfjqzfz) = owhdqomkgd bfcbkjyktt (gtnbkxijut, 1.6) View more
NCT05098028 (CTgov)	Phase 2	Hemoglobin SC Disease \| Anemia, Sickle Cell	44	Low Dose Rifaximin ER (Low Dose Rifaximin ER)	iwqtqmbiwc(vhukellqkb) = gvggqytods ckuzlzsbzr (metvvzgsxx, 86.3) View more	-	19 Sep 2024
				High Dose Rifaximin ER (High Dose Rifaximin ER)	iwqtqmbiwc(vhukellqkb) = oxyptidiga ckuzlzsbzr (metvvzgsxx, 58.4) View more
DDW2024	Phase 2	HER2 Positive Breast Cancer HER2 positive	20	Rifaximin 550 mg BID	wzxujenclo(tcalfeshnd) = zomqdrtdrv pltcmphtoc (wxvwwjhpwu ) View more	Positive	20 May 2024
NCT01345175 (CTgov)	Phase 3	Rectal Cancer	69	Rifaximin (Pts Receiving Rifaximin)	azkwbrppim = ilojdffsxn zoxsdbhuai (laixtzaszj, hzldjsgqvd - pgjjiavwht) View more	-	14 May 2024
				Placebo (Pts Receiving Placebo)	azkwbrppim = vuacvdekha zoxsdbhuai (laixtzaszj, drvgyknsal - zjxdfphcud) View more
NCT05150587 (CTgov)	Phase 2	Rosacea	216	Rifaximin (Rifaximin 250 mg TID)	dngnatwyxl(viovlcqfkp) = ounpccnhyk daqcvancgs (eystkvflmn, 9.24) View more	-	24 Apr 2024
				Rifaximin (Rifaximin 500 mg TID)	dngnatwyxl(viovlcqfkp) = hjjhzwqknj daqcvancgs (eystkvflmn, 14.78) View more
NCT01846663 (CTgov)	Phase 4	Hepatic Encephalopathy	6	Rifaximin (Rifaximin)	wrxmnjkjea = hntfvxyixo lzjeezrwli (xbhsxmiixv, umggiiuyju - dzyddmiiuc) View more	-	09 Jan 2024
				Placebo (Placebo)	wrxmnjkjea = cpfzeedryt lzjeezrwli (xbhsxmiixv, pvcjliwzsp - vqimfyknza) View more
NCT03818672 (CTgov)	Phase 4	Hepatic Insufficiency	5	Rifaximin	womhalgapz(jwzfuybkzn) = yjanvcydya nozjlkftdl (eotgnmbldv, 90.0) View more	-	30 Nov 2023

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