Last update 18 Dec 2024

Rifampin

Last update 18 Dec 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

3-(((4-Methyl-1-piperazinyl)imino)methyl)rifamycin SV, Compound Bismuth Aluminate, Rafampicin

+ [32]

Target

RNAP

Mechanism

RNAP inhibitors(Bacterial DNA-directed RNA polymerase inhibitors)

Therapeutic Areas

Infectious DiseasesNervous System DiseasesRespiratory Diseases+ [2]

Active Indication

Mycobacterium Avium-Intracellulare InfectionMycobacterium Infections, NontuberculousHaemophilus Infections+ [6]

Inactive Indication

Autoimmune DiseasesDiabetes MellitusMultiple Sclerosis+ [1]

Originator Organization

Oxford Pharmaceuticals LLC

Active Organization

Chengdu First Pharmaceutical Co. Ltd.Sanofi-Aventis Australia Pty Ltd.

Sichuan Rainbow Pharmacy Co. Ltd.

+ [8]

Inactive Organization

Kadmon Corp. LLC

Sanofi SA

Sanofi

Drug Highest PhaseApproved

First Approval Date

US (21 May 1971),

MeningitisPulmonary Tuberculosis

RegulationOrphan Drug (JP), Orphan Drug (AU), Priority Review (AU), Orphan Drug (US)

Structure

Molecular FormulaC43H58N4O12

InChIKeyJQXXHWHPUNPDRT-ZNQWNCHJSA-N

CAS Registry13292-46-1

516

Clinical Trials associated with Rifampin

NCT06498414 / Not yet recruitingPhase 2/3IIT

An Adaptive Trial to Find the Safest and Shortest TB Preventive Regimens.

Our study rationale is based on:
1. Tuberculosis Preventive Treatment (TPT) is given to healthy people and needs to be safe;
2. Tuberculosis Preventive Treatment (TPT) with shorter regimens are superior with respect to acceptance, completion, and costs;
3. 4 months of Rifampin 10mg/kg (4R10) is the safest regimen, but is completed by <80% of patients;
4. The safety of 2 months of Rifampin 20mg/kg (2R20) is similar to that of 4 months of Rifampin 10mg/kg (4R10), but completion is a concern;
5. 1-month regimens have promising efficacy;
6. Safety and tolerability must be carefully assessed with comparisons to 4 months of Rifampin 10mg/kg (4R10), and head-to-head with each other.
OBJECTIVES: The investigator will use a Bayesian adaptive Phase 2 randomized open-label trial design to test at least three experimental Tuberculosis Preventive Treatment (TPT) regimens to identify at least one regimen of ≤2 months duration that has non-inferior safety, completion, and tolerability in adults and children relative to the reference Tuberculosis Preventive Treatment (TPT) regimen. The shortest, safest, and best tolerated regimen identified in this Phase 2 trial will be tested for effectiveness and efficacy in a Phase 3 trial.
Specific Tuberculosis Preventive Treatment (TPT) regimens (All are daily and self-administered) Reference: Rifampin at a dose of 10 mg/kg/day for 4 months (4R10); Experimental: 1) Rifampin at 20 mg/kg/day for 2 months (2R20); (2) one month Levofloxacin and Rifapentine (1LP). At a later stage a 3rd experimental regimen will be selected and added: one another novel 1-2-month regimen identified from pre-clinical and clinical studies. When selected, this will be explained fully including preliminary data on safety and efficacy in an amended protocol and consent - which will be submitted for ethics and regulatory approval at that time).

Start Date01 Feb 2025

Sponsor / Collaborator

Mcgill University Health Centre

[+1]

NCT06192160 / Not yet recruitingPhase 2IIT

A Phase 2 Randomized, Adaptive, Dose-Ranging, Open-Label Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis

A5409/RAD-TB is an adaptive Phase 2 randomized, controlled, open-label, dose-ranging, platform protocol to evaluate the safety and efficacy of multidrug regimens for the treatment of adults with drug-susceptible pulmonary tuberculosis (TB).
A5409 hypothesizes that novel regimens for the treatment of pulmonary tuberculosis will result in superior early efficacy, as determined by longitudinal mycobacteria growth indicator tube (MGIT) liquid culture time to positivity (TTP) measurements over the first 6 weeks of treatment, and will have acceptable safety and tolerability over 8 weeks of treatment relative to standard of care [(SOC) isoniazid/rifampicin/pyrazinamide/ethambutol (HRZE)].
The study will run for 52 weeks, inclusive of 26 weeks of TB treatment comprised of 8 weeks of experimental or SOC treatment (based on treatment arm assignment) followed by 18 weeks of SOC treatment with 45 participants in each experimental treatment arm and at least 90 participants in the SOC arm.

Start Date10 Jan 2025

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

[+1]

NCT06701136 / Not yet recruitingPhase 1

A Clinical Study to Evaluate the Drug-Drug Interaction and Food Effect of Sudapyridine(WX-081) Tablet With Itraconazole and Rifampin in Healthy Chinese Adult Volunteers

The goal of this clinical trial is to learn how Sudapyridine (WX-081) tablets interact with other drugs and how food intake affects its pharmacokinetics in healthy Chinese adults. The main questions it aims to answer are:
How does itraconazole (a strong CYP3A inhibitor) affect the pharmacokinetics of Sudapyridine? How does rifampin (a strong CYP3A inducer) affect the pharmacokinetics of Sudapyridine? How does food intake influence the pharmacokinetics of Sudapyridine?
Participants will:
Take Sudapyridine alone, with itraconazole, with rifampin, and under fed and fasting conditions based on a predefined sequence.
Attend multiple clinic visits for blood sample collection and safety evaluations.
Researchers will compare the pharmacokinetic parameters of Sudapyridine under these conditions to determine the impact of drug-drug interactions and food.

Start Date12 Dec 2024

Sponsor / Collaborator

Shanghai Jiadan Pharmaceutical Technology Co., Ltd.

100 Clinical Results associated with Rifampin

100 Translational Medicine associated with Rifampin

100 Patents (Medical) associated with Rifampin

27,391

Literatures (Medical) associated with Rifampin

01 Feb 2025·Infectious disorders drug targets

Vigilance Needed in Treating a Child with Disseminated TB: A Case Report

Article

Author: Keshari Kar, Bikram ; Gaikwad, Nitin Rewaram ; Chouhan, Dushyant ; Velmurugan, Hemasri ; Thangaraju, Pugazhenthan ; Neelambaram, Krishnapriya ; Gurunthalingam, Meenalotchini Prakash

Background::

Tuberculosis is still one of the biggest causes of infection-related death around the world. Disseminated tuberculosis is a potentially fatal disease caused by the haematogenous spread of Mycobacterium tuberculosis. First-line anti-tuberculosis drugs in-clude isoniazid, rifampicin, pyrazinamide, and ethambutol. The first three drugs are known to cause hepatotoxicity.

Case Presentation::

We have, herein, reported a case of Drug-induced Liver Injury (DILI) due to anti-tuberculosis therapy in a one-year-old male child with disseminated tuberculosis. He was started on a fixed-dose combination of Anti-tuberculosis Therapy (ATT; isoniazid 50 mg, rifampicin 75 mg, and pyrazinamide 150 mg) and pyridoxine 10 mg orally. Initially, liver pa-rameters were normal, but later on with the course of the treatment, there was a rapid rise in liver enzymes, suggesting liver injury.

Discussion::

The association between liver injury and anti-tuberculosis therapy has been con-firmed by applying various causality association scales. It is obvious that proper treatment of disseminated tuberculosis can avoid the development of drug-resistant strains that can be harm-ful, worsening the prognosis as there are fewer therapeutic alternatives available. At the same time, there is a need to monitor the patient with ATT-induced DILI.

Conclusion::

The diagnosis of tuberculosis in children is difficult because of the mild, nonspe-cific clinical presentation, which usually reflects the implicated underlying organ. In addition to prompt diagnosis and treatment of disseminated TB, careful monitoring is equally important.

01 Feb 2025·Photodiagnosis and Photodynamic Therapy

Caries affected Dentin biomodification using Bromelain, Riboflavin photosensitizer via UVA, and Chitosan Nanoparticles on shear bond strength and microleakage scores: A SEM evaluation

Article

Author: Alrahlah, Ali ; Almohareb, Thamer ; Maawadh, Ahmed ; AlDeeb, Laila ; Alahdal, Khold ; Alshamrani, Ahoud S

AIMS:

Assessment of the impact of different dentin bio-modifiers i.e., Bromelain, Riboflavin photosensitizer (RFP/Ultraviolet-A), and Chitosan nanoparticles (CHNPs) on the shear bond strength (SBS) and microleakage of composite bonded to acid etched carious affected dentin (CAD).

MATERIALS AND METHODS:

Sixty-four human molars in which carious lesions extend till the middle third of the dentin were included. The infected dentin was removed and CAD was exposed. All specimens were categorized into four groups based on the application of dentin bio-modifier (n = 16) Group 1 (No dentin modifier), Group 2 (Bromelain), Group 3 (RFP/UVA), and Group 4 (CHNPs). Dental adhesive application and composite buildup were performed. A dye penetration test was used to assess marginal leakage. Resin CAD interface assessment was performed using SEM. For SBS and failure pattern analysis, a universal testing machine and stereomicroscope were used respectively. One-way ANOVA followed by Bonferroni's posthoc test was employed to analyze the differences among various groups (p≤0.05) RESULTS: The lowest microleakage (13.27 ± 0.10) and highest SBS (11.64 ± 0.16 MPa) were observed in Group 2 (Bromelain). However, the maximum values of marginal leakage (37.21 ± 0.21) and minimum SBS (7.34 ± 0.07 MPa) were detected in Group 1 samples. The length of resin tags in the Group 2 specimens (Bromelain) was found to be the highest (102.11 ± 5.12 μm)^. However, Group 1 (No modifier) exhibited the lowest resin tag length (50.45 ± 2.37 μm).

CONCLUSION:

Caries-affected dentin modified with Bromelain resulted in satisfactory SBS with minimal microleakage scores. Chitosan nanoparticles and RFP/Ultraviolet-A also presented better outcomes in terms of microleakage and SBS than the control.

01 Jan 2025·DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE

Coxiella burnetii caused lumbar infection: A case report and literature review

Review

Author: Liu, Qiuyuan ; Xin, Qian ; Guo, Qingming ; Zhao, Ziyun ; Mu, Xiaofeng ; Bi, Qingqing ; Wu, Weiwei ; Chen, Juan

Coxiella burnetii (C. burnetii)is a significant microbe linked to the zoonotic disease Q fever, known for its atypical clinical manifestations and sporadic cases. It can cause lumbar infections. In this report, we present a 66-year-old male sheep farmer who experienced low back pain for five months, with worsening numbness in both lower limbs over two months. Several standard diagnostic tests were negative. Metagenomic next-generation sequencing (mNGS) was performed on lumbar spine tissue obtained via biopsy, identifying C. burnetii infection. After surgical excision of the lesion, the patient received a combination of levofloxacin, doxycycline, rifampicin, and supportive medications. Postoperatively, the patient's condition stabilized, showing a significant reduction in low back pain. This case highlights mNGS as a valuable tool for diagnosing rare infections, especially in patients with a history of animal exposure. It underscores the importance of considering zoonotic infections and the need for combined antibiotic and surgical management in suspected cases.

253

News (Medical) associated with Rifampin

13 Dec 2024

·www.businesswire.com

Gilead’s Seladelpar Receives Positive CHMP Opinion for Primary Biliary Cholangitis

FOSTER CITY, Calif.--( BUSINESS WIRE )--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending seladelpar for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA. The final European Commission decision is anticipated in the first quarter of 2025. This follows the accelerated approval by the U.S. Food and Drug Administration (FDA) in August 2024. PBC is a rare, chronic, autoimmune disease of the bile ducts that affects approximately 15 per 100,000 people in Europe, primarily women, and can cause liver damage and possible liver failure if untreated. The most common symptoms of PBC are pruritus (chronic itch) and fatigue, which can be debilitating for some people. The disease currently has no cure and treatment goals for people living with PBC include suppressing liver damage and reducing the symptoms related to cholestasis. The effect of treatment on slowing disease progression is primarily measured by an improvement in liver biochemical tests, including the normalization of alkaline phosphatase (ALP) levels, an important marker of disease progression in PBC. “ This positive opinion from the Committee confirms promising clinical benefit and value of seladelpar, which has been underscored by its differentiated body of data,” said Palak Trivedi, MD, BSc (Hons), MBBS, MRCP (UK), ESEGH, PhD, Associate Professor and Consultant Hepatologist at the Queen Elizabeth Hospital in Birmingham. “ After many years of treating people with PBC, I have seen the critical unmet need for additional effective and symptom-directed treatment options. Today’s recommendation of a potential new therapy that can help treat both the disease and improve symptoms that impact quality of life is a significant milestone for the PBC community.” The positive opinion was supported primarily by data from the pivotal placebo-controlled Phase 3 RESPONSE study. In the study, 62% of participants taking seladelpar achieved the primary endpoint of composite biochemical response at month 12 compared with 20% of participants taking placebo. Treatment with seladelpar led to normalization of ALP values in 25% of trial participants at month 12. This change was not seen in any trial participants receiving placebo. ALP is a cholestatic marker that is a predictor of risk for liver transplant and death. Change from baseline pruritus score at month 6 was a key secondary endpoint; treatment with seladelpar led to a statistically significant reduction in pruritus compared with placebo. Participants entering the study with moderate to severe itch experienced a 3.2-point improvement on a pruritus scale of 0-10 after six months of treatment with seladelpar, compared to a decrease of 1.7 points with placebo. “ We are encouraged by the CHMP’s positive opinion as we are one step closer to providing seladelpar to people living with PBC in Europe,” said Timothy Watkins, MD, MSc, Vice President, Clinical Development of Inflammation Therapeutics, Gilead Sciences. “ There are still people living with PBC who do not have an adequate response to current medicines or who are still experiencing symptoms, such as debilitating itch. As a leader in liver disease, Gilead is committed to bringing forth therapies that not only improve markers of disease progression but also help alleviate symptoms which impact the lives of people living with this rare liver condition.” In addition to Europe, Gilead is working with regulatory authorities on marketing applications for seladelpar in other parts of the world. In August 2024, the FDA granted accelerated approval for seladelpar for the treatment of PBC in combination with (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. Continued approval of seladelpar for the approved indication may be contingent on verification and description of clinical benefit in confirmatory trial(s). About RESPONSE (NCT04620733) RESPONSE is a Phase 3, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of seladelpar in adults with PBC who have shown inadequate response or intolerance to first-line treatment with UDCA. The trial enrolled 193 participants across multiple sites worldwide. RESPONSE assessed key biomarkers of cholestasis, including ALP levels, as well as secondary endpoints related to liver function and patient quality of life. Participants in the RESPONSE trial received a daily oral dose of 10 mg of seladelpar or placebo for 12 months, with a focus on measuring changes in ALP and other relevant liver function tests. The trial aimed to address the high unmet need for effective second-line therapies for individuals with PBC, providing important insights into the long-term management of this chronic liver disease. About PBC PBC is a rare, chronic inflammatory liver disease primarily affecting women (1 in 1,000 women over the age of 40 or about 110,000 people in Europe). PBC is characterized by impaired bile flow (known as cholestasis) and the accumulation of toxic bile acids in the liver, leading to inflammation and destruction of the bile ducts within the liver and causing increased levels of ALP, alanine transaminase (ALT) and gamma-glutamyl transferase (GGT), enzymes found primarily in the liver, as well as total bilirubin. The most common symptoms of PBC are pruritus and fatigue, which can be debilitating for some people. Progression of PBC is associated with an increased risk of liver-related mortality. About Seladelpar Seladelpar is an oral PPAR-delta agonist, or delpar, for the treatment of PBC. PPAR-delta has been shown to regulate critical metabolic and liver disease pathways. Preclinical and clinical data indicate seladelpar has anticholestatic, anti-inflammatory, antipruritic, and antifibrotic effects. Seladelpar has potential to help meet the current unmet need of people living with PBC, as the first and only treatment that achieved statistically significant improvements across biochemical response, ALP normalization, and pruritus versus placebo. Pruritus is a common symptom that can significantly impair quality of life in people with PBC. Livdelzi ® (seladelpar) was granted accelerated approval for the treatment of PBC by the U.S. Food and Drug Administration (FDA) in August 2024. Seladelpar received FDA Breakthrough Therapy Designation, as well as Orphan Drug Designation for the treatment of people living with PBC. Seladelpar has Priority Medicine (PRIME) designation in the EU, which is assigned to optimize the development of novel medicines that target conditions with an unmet medical need for which no treatment options exists or where they can offer a major therapeutic advantage over existing treatments. Seladelpar is also under review by the UK Medicines and Healthcare products Regulatory Agency (MHRA). As part of the FDA accelerated approval, Gilead has committed to a confirmatory long-term outcomes study called AFFIRM, which has already been initiated in people with compensated cirrhosis. Continued U.S. approval may be contingent upon verification of clinical benefit in confirmatory trial(s). U.S. Indication for Livdelzi (seladelpar) 10mg capsules Livdelzi is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. This indication is approved under accelerated approval based on a reduction of ALP. Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Limitations of Use: Use of Livdelzi is not recommended in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy). U.S. Important Safety Information for Livdelzi Warnings and Precautions Fractures: Fractures occurred in 4% of LIVDELZI-treated patients compared to no placebo-treated patients. Consider the risk of fracture in the care of patients treated with LIVDELZI and monitor bone health according to current standards of care. Liver Test Abnormalities: LIVDELZI has been associated with dose-related increases in serum transaminase (AST and ALT) levels > 3 x ULN in patients receiving 50 mg and 200 mg once daily (5x and 20x higher than the recommended dosage of 10 mg once daily). Perform baseline clinical and laboratory testing when starting LIVDELZI and monitor thereafter according to routine patient management. Interrupt treatment if the liver tests (ALT, AST, total bilirubin, and/or ALP) worsen, or if the patient develops signs and symptoms of clinical hepatitis (eg, jaundice, right upper quadrant pain, eosinophilia). Consider permanent discontinuation if liver tests worsen after restarting LIVDELZI. Biliary Obstruction: Avoid use of LIVDELZI in patients with complete biliary obstruction. If biliary obstruction is suspected, interrupt LIVDELZI and treat as clinically indicated. Adverse Reactions The most common adverse reactions (≥5%) with LIVDELZI were headache (8%), abdominal pain (7%), nausea (6%), abdominal distension (6%), and dizziness (5%). Drug Interactions OAT3 Inhibitors and Strong CYP2C9 Inhibitors: Avoid coadministration with LIVDELZI due to increased LIVDELZI exposure. Rifampin: Monitor biochemical response (e.g., ALP and bilirubin) when patients initiate rifampin during LIVDELZI treatment. Coadministration may result in delayed or suboptimal biochemical response of LIVDELZI. Dual Moderate CYP2C9 and Moderate-to-Strong CYP3A4 Inhibitors and BCRP Inhibitors (e.g., cyclosporine): Monitor closely for adverse effects. Concomitant administration with LIVDELZI may increase LIVDELZI exposure. CYP2C9 Poor Metabolizers Using Moderate-to-Strong CYP3A4 Inhibitors: Monitor more frequently for adverse reactions as concomitant use of a moderate-to-strong CYP3A4 inhibitor in patients who are CYP2C9 poor metabolizers may increase LIVDELZI exposure and risk of LIVDELZI adverse reactions. Bile Acid Sequestrants: Administer LIVDELZI at least 4 hours before or 4 hours after taking a bile acid sequestrant, or at as great an interval as possible. Pregnancy and Lactation Pregnancy: There are insufficient data from human pregnancies exposed to LIVDELZI to allow an assessment of a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Report pregnancies to Gilead Sciences, Inc., at 1-800-445-3235. Lactation: There are no data on the presence of LIVDELZI in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for LIVDELZI and any potential adverse effects on the breastfed infant from LIVDELZI. About Gilead Sciences in Liver Disease For decades, Gilead has pioneered the way forward to improve the lives of people living with liver disease around the world. The company has helped to transform hepatitis C from a chronic condition into one that can be cured for millions of people. For individuals living with hepatitis B or D, Gilead's focus on advancing medicines drives hope that today’s research will turn into tomorrow’s cures. Beyond viral hepatitis, Gilead is working to deliver advanced treatments for people living with PBC. The commitment of Gilead doesn’t stop there. Through ground-breaking science and collaborative partnerships, the company strives to create healthier futures for everyone living with liver disease. Gilead remains devoted to a future without liver disease. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials, including those involving Livdelzi (seladelpar) (such as the RESPONSE and any confirmatory studies); uncertainties relating to regulatory applications and related filing and approval timelines, including European Commission and MHRA reviews of seladelpar for the treatment of PBC; the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

Clinical ResultBreakthrough TherapyOrphan DrugPhase 3Accelerated Approval

13 Dec 2024

·www.globenewswire.com

HUTCHMED to Receive Milestone Payment from Takeda following First European Reimbursement for FRUZAQLA® (fruquintinib)

— US$10 million milestone payment to HUTCHMED follows first national reimbursement in Europe — — Follows June 2024 European approval of FRUZAQLA® (fruquintinib), the first novel oral targeted therapy in the EU for metastatic colorectal cancer regardless of biomarker status in over a decade — HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Dec. 12, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it will receive a US$10 million milestone payment by its partner Takeda (TSE:4502/NYSE:TAK). Takeda received a national reimbursement recommendation for FRUZAQLA® (fruquintinib) for patients with previously treated metastatic colorectal cancer (“CRC”) in Spain in December 2024, the first national reimbursement recommendation in Europe. CRC is the second most common cause of cancer-related deaths in Europe. FRUZAQLA® was approved by the European Commission (“EC”) of the European Union (“EU”) in June 2024. Takeda has the exclusive worldwide license to further develop, commercialize and manufacture fruquintinib outside of mainland China, Hong Kong and Macau. “We are delighted for both our partner, Takeda, and patients in Spain who will now be able to receive reimbursement for this innovative treatment. This is an important step forward in improving patient access across Europe more broadly,” said Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED. “It also underscores our ongoing collaboration with Takeda and reinforces our shared commitment to addressing the needs of patients with metastatic colorectal cancer.” The approvals by the EC were primarily based on results from the Phase III multiregional FRESCO-2 trial. Data from FRESCO-2 were published in The Lancet in June 2023. FRUZAQLA® was approved in the US in November 2023, in the EU in June 2024, in Switzerland in August 2024, in Canada, Japan and the United Kingdom in September 2024 and in Argentina, Australia and Singapore in October 2024. Regulatory applications are progressing in many other jurisdictions. About CRC CRC is a cancer that starts in either the colon or rectum. According to the International Agency for Research on Cancer/World Health Organization, CRC is the third most prevalent cancer worldwide, associated with more than 1.9 million new cases and 900,000 deaths in 2022. In Europe, CRC was the second most common cancer in 2022, with approximately 538,000 new cases and 248,000 deaths.1,2 In the US, it is estimated that 153,000 patients will be diagnosed with CRC and 53,000 deaths from the disease will occur in 2024.3 In Japan, CRC was the most common cancer, with an estimated 146,000 new cases and 60,000 deaths, in 2022.2 Although early-stage CRC can be surgically resected, metastatic CRC remains an area of high unmet need with poor outcomes and limited treatment options. Some patients with metastatic CRC may benefit from personalized therapeutic strategies based on molecular characteristics; however, most patients have tumors that do not harbor actionable mutations.4,5,6,7,8 About Fruquintinib Fruquintinib is a selective oral inhibitor of all three VEGF receptors (VEGFR-1, -2 and -3). VEGFR inhibitors play a pivotal role in inhibiting tumor angiogenesis. Fruquintinib was designed to have enhanced selectivity that limits off-target kinase activity, allowing for drug exposure that achieves sustained target inhibition and flexibility for potential use as part of a combination therapy. About Fruquintinib Approvals Global regulatory submissions are based on data from two large, randomized, controlled Phase III trials, the global, multi-regional FRESCO-2 trial and the FRESCO trial conducted in China, showing consistent benefit among a total of 734 patients treated with fruquintinib. Safety profiles were consistent across trials. Results from the FRESCO-2 trial were published in The Lancet in June 2023,9 while results from the FRESCO trial were published in The Journal of the American Medical Association, JAMA.10 In mainland China, Hong Kong and Macau, fruquintinib is co-marketed by HUTCHMED and Eli Lilly and Company under the brand name ELUNATE®. It was included in the China National Reimbursement Drug List (NRDL) in January 2020. Since its launch in China, over 100,000 patients with colorectal cancer have been treated with fruquintinib. About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception it has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn. E.U. IMPORTANT SAFETY INFORMATION Please consult the FRUZAQLA (fruquintinib) Summary of Product Characteristics (SmPC) before prescribing. Guidance for use: FRUZAQLA should be initiated by a physician experienced in the administration of anticancer therapy. Patients should be given the package leaflet. CONTRAINDICATIONS: Hypersensitivity to the active substance or to any of the excipients. SPECIAL POPULATIONS: Renal impairment: No dose adjustment is required for patients with mild, moderate, or severe renal impairment; Hepatic impairment: No dose adjustment is required for patients with mild or moderate hepatic impairment. FRUZAQLA is not recommended for use in patients with severe hepatic impairment as FRUZAQLA has not been studied in this population; Elderly: No dose adjustment is required in patients aged 65 years or above; Pediatric population: There is no relevant use of FRUZAQLA in the pediatric population for the indication of metastatic colorectal cancer; Women of childbearing potential / Contraception in females: Women of childbearing potential should be advised to use highly effective contraception during treatment and for at least 2 weeks following the last dose of FRUZAQLA; Pregnancy: There are no clinical data available on the use of FRUZAQLA in pregnant women. Based on its mechanism of action, FRUZAQLA has the potential to cause fetal harm. Animal studies have shown reproductive toxicity, including fetal malformations. FRUZAQLA should not be used during pregnancy unless the clinical condition of the woman requires treatment with FRUZAQLA. If FRUZAQLA is used during pregnancy or if the patient becomes pregnant while on treatment, the patient must be informed of the potential hazard to the fetus; Breast-feeding: The safe use of FRUZAQLA during breast-feeding has not been established. It is not known whether FRUZAQLA or its metabolites are excreted in human milk. There are no animal data on the excretion of FRUZAQLA in animal milk. A risk to the breastfeeding newborns/infants cannot be excluded. Breastfeeding should be discontinued during treatment and for 2 weeks after the last dose; Fertility: There are no data on the effects of FRUZAQLA on human fertility. Results from animal studies indicate that FRUZAQLA may impair male and female fertility. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Hypertension: Hypertension, including hypertensive crisis, has been reported in patients treated with FRUZAQLA. Pre-existing hypertension should be monitored and adequately controlled in accordance with standard medical practices before starting FRUZAQLA treatment. Hypertension should be medically managed with antihypertensive medicinal products and adjustment of the FRUZAQLA dose, if necessary. FRUZAQLA should be permanently discontinued for hypertension that cannot be controlled with antihypertensive therapy or in patients with hypertensive crisis. Hemorrhagic events: Hemorrhagic events have been reported in patients treated with FRUZAQLA, including gastrointestinal (GI) tract events. Serious and sometimes fatal bleeding events have been reported in patients after treatment with FRUZAQLA. Hematologic and coagulation profiles should be monitored in accordance with standard medical practices in patients at risk for bleeding, including those treated with anticoagulants or other concomitant medicinal products that increase the risk of bleeding. In the event of severe bleeding requiring immediate medical intervention, FRUZAQLA should be permanently discontinued. Gastrointestinal perforation: GI perforation events, including fatal events, have been reported in patients treated with FRUZAQLA. Symptoms of GI perforation should be periodically monitored during treatment with FRUZAQLA. FRUZAQLA should be permanently discontinued in patients developing GI perforation. Proteinuria: Proteinuria events have occurred in patients treated with FRUZAQLA. Proteinuria should be monitored before initiation and during treatment with FRUZAQLA in accordance with standard medical practices. If urine dipstick proteinuria ≥ 2 g / 24 hours is detected, dose interruptions, adjustments, or discontinuation may be necessary. FRUZAQLA should be permanently discontinued in patients developing nephrotic syndrome. Palmar-plantar erythrodysesthesia syndrome (PPES): PPES is the most frequently reported dermatological adverse reaction. If Grade ≥2 skin reactions are detected, dose interruptions, adjustments, or discontinuation may be necessary. Posterior reversible encephalopathy syndrome (PRES): PRES has been reported in 1 patient (0.1%) treated with FRUZAQLA in clinical studies. PRES is a rare neurologic disorder that can present with headache, seizure, lethargy, confusion, altered mental function, blindness, and other visual or neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably magnetic resonance imaging (MRI). In patients developing PRES, discontinuation of FRUZAQLA, along with control of hypertension and supportive medical management of other symptoms, are recommended.Impaired wound healing: Impaired wound healing has been reported in 1 patient (0.1%) treated with FRUZAQLA in clinical studies. Patients are recommended to withhold FRUZAQLA for at least 2 weeks prior to surgery. FRUZAQLA should not be resumed for at least 2 weeks after surgery, as clinically indicated when there is evidence of adequate wound healing. Arterial and venous thromboembolic events: It is recommended to avoid starting treatment with FRUZAQLA in patients with a history of thromboembolic events (including deep vein thrombosis and pulmonary embolism) within the past 6 months or if they have a history of stroke and/or transient ischemic attack within the last 12 months. If arterial thrombosis is suspected, FRUZAQLA should be discontinued immediately. INTERACTIONS Effects of other medicinal products on the pharmacokinetics of FRUZAQLA CYP3A inducers Co-administration of FRUZAQLA with rifampicin (a strong CYP3A inducer) 600 mg once daily decreased FRUZAQLA AUCinf by 65% and decreased Cmax by 12%. The concomitant use of FRUZAQLA with strong and moderate CYP3A inducers should be avoided. CYP3A inhibitors Co-administration of FRUZAQLA with itraconazole (a strong CYP3A inhibitor) 200 mg twice daily did not result in clinically meaningful changes in the area under the concentration-time curve (AUC) and Cmax of FRUZAQLA. No dose adjustment of FRUZAQLA is needed during concomitant use with CYP3A inhibitors. Gastric acid lowering agents Co-administration of FRUZAQLA with rabeprazole (a proton pump inhibitor) 40 mg once daily did not result in clinically meaningful changes in the AUC of FRUZAQLA. No dose adjustment of FRUZAQLA is needed during concomitant use with gastric acid lowering agents. Effect of FRUZAQLA on the pharmacokinetics of other medicinal products Medicinal products that are substrates of P-glycoprotein (P-gp) Co-administration of a single dose of dabigatran etexilate 150 mg (a P-gp substrate) with a single dose of FRUZAQLA 5 mg decreased AUC of dabigatran by 9%. No dose adjustment is recommended for P-gp substrates during concomitant use with FRUZAQLA. Medicinal products that are substrates of breast cancer resistance protein (BCRP) Co-administration of a single 10 mg dose of rosuvastatin (a BCRP substrate) with a single 5 mg dose of FRUZAQLA decreased AUC of rosuvastatin by 19%. No dose adjustment is recommended for BCRP substrates during concomitant use with FRUZAQLA. UNDESIRABLE EFFECTS: The most commonly reported adverse reactions with FRUZAQLA are: Very common(frequency ≥1/10)Thrombocytopenia, hypothyroidism, anorexia, hypertension, dysphonia, diarrhea, stomatitis, aspartate aminotransferase increased, total bilirubin increased, alanine aminotransferase increased, palmar-plantar erythrodysesthesia syndrome, musculoskeletal discomfort, arthralgia, proteinuria, asthenia, and fatigueCommon(≥1/100 to <1/10)Pneumonia, upper respiratory tract infection, bacterial infections, leukopenia, neutropenia, hypokalemia, epistaxis, throat pain, gastrointestinal hemorrhage, gastrointestinal perforation, pancreatic enzymes increased, oral pain, rash, and mucosal inflammation For US Prescribing Information: https://www.fruzaqla.com/sites/default/files/resources/fruzaqla-prescribing-information.pdf For Japan Prescribing Information: https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/400256_42910H0M1028_1_01 For EU Prescribing Information: https://www.ema.europa.eu/en/documents/product-information/fruzaqla-epar-product-information_en.pdf Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including its expectations regarding the therapeutic potential of fruquintinib for the treatment of such patients with CRC and the further clinical development of fruquintinib in this and other indications. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the sufficiency of clinical data to support approval of fruquintinib for the treatment of patients with CRC or other indications in jurisdictions such as Europe, its potential to gain approvals from regulatory authorities, the safety profile of fruquintinib, HUTCHMED and/or Takeda’s ability to fund, implement and complete its further clinical development and commercialization plans for fruquintinib, the timing of these events, each party’s ability to satisfy the terms and conditions under the license agreement; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials or the regulatory pathway for fruquintinib; and Takeda’s ability to successfully develop and commercialize fruquintinib. In addition, as certain studies rely on the use of other drug products as combination therapeutics with fruquintinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. CONTACTS Investor Enquiries+852 2121 8200 /ir@hutch-med.com Media Enquiries Ben Atwell / Alex Shaw, FTI Consulting+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) /HUTCHMED@fticonsulting.comZhou Yi, Brunswick+852 9783 6894 (Mobile) /HUTCHMED@brunswickgroup.com Nominated Advisor Atholl Tweedie / Freddy Crossley / Rupert Dearden, Panmure Liberum+44 (20) 7886 2500 ___________________________ 1Bray F,et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 Countries.CA Cancer J Clin.2024;74(3):229-263. doi:10.3322/caac.21834.2Ferlay J,et al. Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer. Available from:https://gco-iarc-who-int.libproxy1.nus.edu.sg/today, accessed 12 June 2024.3American Cancer Society. Cancer Facts & Figures 2024. Atlanta,American Cancer Society; 2024.4Bando H, et al. Therapeutic landscape and future direction of metastatic colorectal cancer.Nat Rev Gastroenterol Hepatol2023; 20(5)306-322. doi:10.1038/s41575-022-00736-1.5D'Haene N, et al. Clinical application of targeted next-generation sequencing for colorectal cancer patients: a multicentric Belgian experience.Oncotarget.2018;9(29):20761-20768. Published 2018 Apr 17. doi:10.18632/oncotarget.25099.6Venderbosch S, et al. Mismatch repair status and BRAF mutation status in metastatic colorectal cancer patients: A pooled analysis of the CAIRO, CAIRO2, COIN, and FOCUS Studies.Clinical Cancer Res.2014; 20(20):5322–5330. doi:10.1158/1078-0432.ccr-14-0332.7Koopman M, et al. Deficient mismatch repair system in patients with sporadic advanced colorectal cancer.Br J Cancer.2009;100(2), 266–273. doi:10.1038/sj.bjc.6604867.8Ahcene Djaballah S, et al. HER2 in Colorectal Cancer: The Long and Winding Road From Negative Predictive Factor to Positive Actionable Target.Am Soc Clin Oncol Educ Book.2022;42:1-14. doi:10.1200/EDBK_351354.9Dasari NA, et al. Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer (FRESCO-2): an international, multicentre, randomised, double-blind, Phase III study.Lancet.2023;402(10395):41-53. doi:10.1016/S0140-6736(23)00772-9.10Li J,et al. Effect of Fruquintinib vs Placebo on Overall Survival in Patients With Previously Treated Metastatic Colorectal Cancer: The FRESCO Randomized Clinical Trial.JAMA. 2018;319(24):2486-2496. DOI:10.1001/jama.2018.7855.

Drug ApprovalPhase 3ImmunotherapyClinical ResultLicense out/in

18 Nov 2024

·www.globenewswire.com

BioCryst Launches ORLADEYO® (berotralstat) in Ireland

RESEARCH TRIANGLE PARK, N.C., Nov. 18, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the Health Services Executive (HSE) in Ireland has recommended ORLADEYO® (berotralstat) for the routine prevention of recurrent attacks of hereditary angioedema (HAE) in eligible patients 12 years and older. With this recommendation, HAE patients in Ireland will have access to the first oral, once-daily therapy for the reduction of recurrent HAE attacks. “The positive HSE recommendation of ORLADEYO broadens access to modern prophylaxis, providing greater choice for prescribing physicians and potentially a better quality of life for HAE patients in Ireland,” said Charlie Gayer, chief commercial officer of BioCryst. The HSE decision in Ireland follows the European Commission marketing authorization of ORLADEYO in April 2021. To date, ORLADEYO is licensed in 44 countries. About ORLADEYO® (berotralstat)ORLADEYO® (berotralstat) is the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years and older. One capsule of ORLADEYO per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein. U.S. Indication and Important Safety Information INDICATIONORLADEYO® (berotralstat) is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older. Limitations of useThe safety and effectiveness of ORLADEYO for the treatment of acute HAE attacks have not been established. ORLADEYO should not be used for the treatment of acute HAE attacks. Additional doses or dosages of ORLADEYO higher than 150 mg once daily are not recommended due to the potential for QT prolongation. IMPORTANT SAFETY INFORMATIONAn increase in QT prolongation was observed at dosages higher than the recommended 150 mg once-daily dosage and was concentration dependent. The most common adverse reactions (≥10% and higher than placebo) in patients receiving ORLADEYO were abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease. A reduced dosage of 110 mg taken orally once daily with food is recommended in patients with moderate or severe hepatic impairment (Child-Pugh B or C). Berotralstat is a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein. P-gp inducers (eg, rifampin, St. John’s wort) may decrease berotralstat plasma concentration, leading to reduced efficacy of ORLADEYO. The use of P-gp inducers is not recommended with ORLADEYO. ORLADEYO at a dose of 150 mg is a moderate inhibitor of CYP2D6 and CYP3A4. For concomitant medications with a narrow therapeutic index that are predominantly metabolized by CYP2D6 or CYP3A4, appropriate monitoring and dose titration is recommended. ORLADEYO at a dose of 300 mg is a P-gp inhibitor. Appropriate monitoring and dose titration is recommended for P-gp substrates (eg, digoxin) when coadministering with ORLADEYO. The safety and effectiveness of ORLADEYO in pediatric patients <12 years of age have not been established. There are insufficient data available to inform drug-related risks with ORLADEYO use in pregnancy. There are no data on the presence of berotralstat in human milk, its effects on the breastfed infant, or its effects on milk production. To report SUSPECTED ADVERSE REACTIONS, contact BioCryst Pharmaceuticals, Inc. at 1-833-633-2279 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch/ Please see full Prescribing Information. The Irish Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL) for ORLADEYO (berotralstat) can be found through medicines.ie. Anyone can report suspected side effects to the HPRA. You can submit a report by visiting the HPRA’s reporting webpage to complete an online form hpra.ie/report. Adverse events should also be reported to BioCryst Pharmaceuticals at medinfoeurope@biocryst.com or +353 1 699 4405. About BioCryst Pharmaceuticals BioCryst Pharmaceuticals is a global biotechnology company with a deep commitment to improving the lives of people living with hereditary angioedema and other rare diseases. BioCryst leverages its expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and protein therapeutics to target difficult-to-treat diseases. BioCryst has commercialized ORLADEYO® (berotralstat), the first oral, once-daily plasma kallikrein inhibitor, and is advancing a pipeline of small-molecule and protein therapies. For more information, please visit www.biocryst.com or follow us on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements, including statements regarding BioCryst’s plans and expectations for ORLADEYO. These statements involve known and unknown risks, uncertainties and other factors which may cause BioCryst’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: BioCryst’s ability to successfully implement or maintain its commercialization plans for ORLADEYO; risks related to government actions, including that decisions and other actions, including as they relate to pricing, may not be taken when expected or at all, or that the outcomes of such decisions and other actions may not be in line with BioCryst’s current expectations; the commercial viability of ORLADEYO, including its ability to achieve sustained market acceptance and demand; the FDA, HSE, or other applicable regulatory agency may require additional studies beyond the studies planned for products and product candidates, may not provide regulatory clearances which may result in delay of planned clinical trials, may impose certain restrictions, warnings, or other requirements on products and product candidates, may impose a clinical hold with respect to product candidates, or may withhold, delay or withdraw market approval for products and product candidates; BioCryst’s ability to successfully manage its growth and compete effectively; and risks related to the international expansion of BioCryst’s business. Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, which identify important factors that could cause actual results to differ materially from those contained in BioCryst’s projections and forward-looking statements. BCRXW Contact: John Bluth+1 919 859 7910jbluth@biocryst.com Niamh Lyons+353 87 639 7083nlyons@biocryst.com

Drug Approval

100 Deals associated with Rifampin

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KEGG	Wiki	ATC	Drug Bank
D00211	Rifampin	J04AB02	DB01045

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Mycobacterium Avium-Intracellulare Infection	JP	Daiichi Sankyo Co., Ltd.	20 May 2011
Mycobacterium Infections, Nontuberculous	JP	Daiichi Sankyo Co., Ltd.	20 May 2011
Haemophilus Infections	AU	Sanofi-Aventis Australia Pty Ltd.	21 Jan 2009
Meningococcal Infections	US	Sanofi-Aventis U.S. LLC	25 May 1989
Leprosy	CN	Leshan Sanjiu Long March Pharmaceuticals Co. Ltd.	01 Jan 1981
Leprosy	CN	Maoxiang Group Jilin Pharmacy Co. Ltd.	01 Jan 1981
Leprosy	CN	Sinopharm Group Co., Ltd.	01 Jan 1981
Leprosy	CN	Chengdu First Pharmaceutical Co. Ltd.	01 Jan 1981
Leprosy	CN	Sichuan Rainbow Pharmacy Co. Ltd.	01 Jan 1981
Leprosy	CN	Chengdu Tongde Pharmaceutical Co. Ltd.	01 Jan 1981
Tuberculosis	CN	Sichuan Rainbow Pharmacy Co. Ltd.	01 Jan 1981
Tuberculosis	CN	Chengdu First Pharmaceutical Co. Ltd.	01 Jan 1981
Tuberculosis	CN	Maoxiang Group Jilin Pharmacy Co. Ltd.	01 Jan 1981
Tuberculosis	CN	Sinopharm Group Co., Ltd.	01 Jan 1981
Tuberculosis	CN	Leshan Sanjiu Long March Pharmaceuticals Co. Ltd.	01 Jan 1981
Tuberculosis	CN	Chengdu Tongde Pharmaceutical Co. Ltd.	01 Jan 1981
Meningitis	US	Oxford Pharmaceuticals LLC	21 May 1971
Pulmonary Tuberculosis	US	Oxford Pharmaceuticals LLC	21 May 1971

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Prosthetic joint infection	Phase 3	FR	Sanofi	01 Apr 2009
Multiple Sclerosis	Phase 1	US	Sanofi	18 May 2020
Autoimmune Diseases	Phase 1	GB	Kadmon Corp. LLC	09 Apr 2018
Diabetes Mellitus	Phase 1	FR	Sanofi	27 Feb 2017
Frontotemporal Dementia	Preclinical	US	medilabo RFP, Inc.	07 Mar 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04918771 (CTgov)	Phase 3	Viral respiratory infection	435	Raphamin (Raphamin)	ylulvbuead(oxwmqgfvsl) = mhwmrfydwc dbaslxczfr (ulghtpffff, ealvqdamae - bocneojevu) View more	-	15 Oct 2024
				Placebo (Placebo)	ylulvbuead(oxwmqgfvsl) = mdowmflnln dbaslxczfr (ulghtpffff, duglcrexeo - nakskedvto) View more
NCT04021121 (ALTER, CTgov)	Phase 2	Tuberculosis, Meningeal	40	High dose RIF+LZD (High Dose RIF With LZD)	umajyrlsay(decbfjwgfi) = nxkqeepjoe keqkysjrqj (hdtqiazcfh, umjdnzxpku - hbjxtspqoo) View more	-	01 Oct 2024
				Standard dose RIF+LZD (Standard Dose RIF With LZD)	umajyrlsay(decbfjwgfi) = qspcnomzro keqkysjrqj (hdtqiazcfh, wygdxnuuiy - ogyeotnoxy) View more
NCT04485156 (Pubmed \| Tuberc Respir Dis (Seoul)) Manual	Phase 3	Pulmonary Tuberculosis	58	rifampicinrisoniazid,pyrazinamideand pyrazinamide	flqoyqdhme(zqqzgatnqq) = rsuvxgfaxz mlspeuflum (voekhmkfyn )	Negative	27 Sep 2024
				Standard 6-month regimen	flqoyqdhme(zqqzgatnqq) = lcitaxqpnj mlspeuflum (voekhmkfyn )
ATS2024	Not Applicable	-	-	Rifampin	pndyuldbbd(gioagtpcus) = progressive liver failure mwffeqjkeu (sacbqnixpq ) View more	-	19 May 2024
AUA2024	Not Applicable	-	-	RIFAMPIN (Sacral neuromodulation (SNM) device biofilms)	ebidxtlzcz(gaayzutfgq) = mbgtcpbfkl vehizkhfsc (buujadjjut )	-	01 May 2024
NCT03988933 (Pubmed) Manual	Phase 2	Tuberculosis First line	1,368	rifampicinose group (10 mg/kg once daily for 4 months)	uekyckcrex(qwixoykito) = gqlrweapgc eibucqnpsn (gmmstkzqec )	Negative	26 Mar 2024
				rifampicinroup (20 mg/kg daily for 2 months)	uekyckcrex(qwixoykito) = tupotdymrx eibucqnpsn (gmmstkzqec )
NCT04525235 (Pubmed \| Antimicrob Agents Chemother)	Phase 1	Pulmonary Tuberculosis	25	RIF40	tmvperbndv(jmymzyhtly) = siwsbdldrg redfujfjho (vaxsilfxyj, 96 - 115) View more	Positive	18 Oct 2023
NCT03174184 (COMRADE, CTgov)	Phase 2	Pulmonary Tuberculosis	112	MEROPENEM 2 grams TID+Rifampin+Amoxicillin/Clavulanate Potassium 500 MG-125 MG Oral Tablet (Rifampin Resistant A)	bfsvxbygqp(vhokdqnjod) = vsfshczmiv fswgjswsjd (fdlrfkjgqe, pcofwicdqn - zocowkeijd) View more	-	19 Jul 2023
				MEROPENEM 2 grams TID+Amoxicillin/Clavulanate Potassium 500 MG-125 MG Oral Tablet (Rifampin Resistant B)	bfsvxbygqp(vhokdqnjod) = xiwedcpukr fswgjswsjd (fdlrfkjgqe, wscfpxxgxg - nsobgzsruy) View more
NCT02256696 (CTgov)	Phase 2	Pulmonary Tuberculosis	157	PA-824+Rifampin+Isoniazid+Pyrazinamide (Arm 1)	uyujcdsqpe(pymqdofctq) = jdnuhqomvx ghidllmzzt (hrcrqpvnbm, ydhacfsmtm - msikgeqgkq) View more	-	18 Jul 2023
				PA-824+Rifabutin+Isoniazid+Pyrazinamide (Arm 2)	uyujcdsqpe(pymqdofctq) = ydpcsgbxfh ghidllmzzt (hrcrqpvnbm, bfygufuatm - pzmiuqqamn) View more
ALTER trial (S25.003) (AAN2023)	Phase 2	Tuberculosis, Meningeal HIV	23	Linezolid 1200 mg	jgowfxfkac(atkorpcdpk) = n=1 piezsxoylv (gkqdtjpekt ) View more	-	25 Apr 2023
				High-dose rifampin

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