This is a Phase 3, multi-center, randomized, double blind, placebo controlled, clinical study of bucillamine (2 dosage levels) in patients with mild-moderate COVID-19. Patients will be randomized 1:1:1 to receive bucillamine 100 mg 3 times a day (TID), bucillamine 200 mg TID or placebo TID for up to 14 days. After the first interim analysis when a single dose is selected, patients will then be randomized 1:1 to the selected bucillamine dose or placebo. This dose has now been chosen as 600 mg. The study will be overseen by an independent Data and Safety Monitoring Board (DSMB). Up to 50 centers in the United States will conduct this study. Up to 1000 patients will be enrolled in this study. Patients will participate in the study approximately 45 days.

Start Date27 Nov 2020

Sponsor / Collaborator

Revive Therapeutics Ltd.

NCT02942420

/ Unknown statusPhase 2

Phase 2 Multi-Center, Dose Escalation Trial To Assess The Safety And Effectiveness Of Bucillamine On Urinary Cystine Excretion And Cystine Capacity In Patients With Cystinuria

Subjects on a standard regimen of tiopronin (cystine binding thiol drug; CBTD) plus prescribed first-line therapy (i.e. on a hydration, alkali therapy and dietary restriction) who are failing therapy will be selected for this trial.
After completing informed consent, the subject will have Screening consisting of medication history and physical examination with vital signs. Samples of blood and urine will be taken for clinical laboratory and urinalysis. Patients will undergo a 12-lead ECG test. A history of side effects with current CBTD as well as laboratory recordings of abnormalities attributable to treatment will also be recorded.
Subjects will be dosed in a sequential manner, starting with the low dose group (300 mg/day), then proceeding to the 600 mg.day dose group.. Safety and tolerability will be monitored closely by an Independent Medical Monitor (IMM) and based on the IMM's assessment that it is safe to proceed to the higher dose (600 mg/day), subsequent subjects will be enrolled into that group. Up to 15 subjects each will be enrolled into either Group A or Group B.
After 7 days on the assigned bucillamine dose, a 24-hour urine sample will be taken and after completing the Day 8 safety visit, subjects will undergo a 7 day washout where no CBTDs will be taken. Thereafter, subjects will be allowed to resume their originally prescribed CBTDs under Investigator's supervision.
One week following study drug discontinuation, subjects will return to the clinic for follow-up safety assessments.

Start Date01 May 2017

Sponsor / Collaborator

Revive Therapeutics Ltd.

NCT02330796

/ CompletedPhase 2

A RANDOMIZED, MULTICENTRE PHASE IIa OPEN-LABEL, ACTIVE-COMPARATOR TRIAL TO ASSESS THE EFFICACY AND SAFETY OF TWO REGIMENS OF BUCILLAMINE 100 MG TABLETS AS COMPARED TO COLCHICINE 0.6 MG TABLETS FOR THE TREATMENT OF AN ACUTE GOUT FLARE IN SUBJECTS WITH MODERATE TO SEVERE GOUT.

A Phase IIA, open-label, multicenter, active-controlled, parallel-group clinical trial designed to evaluate the safety and efficacy of two doses of Bucillamine compared with low-dose Colchicine in the treatment of patients with acute gout flare.

Start Date01 Apr 2015

Sponsor / Collaborator

Revive Therapeutics Ltd.

100 Clinical Results associated with Bucillamine

100 Translational Medicine associated with Bucillamine

100 Patents (Medical) associated with Bucillamine

458

Literatures (Medical) associated with Bucillamine

01 Apr 2025·AMERICAN JOURNAL OF TRANSPLANTATION

Neural epidermal growth factor-like 1 protein-positive membranous nephropathy in renal allografts: A series of 6 patients

Article

Author: Caza, Tiffany ; Kurien, Anila Abraham ; Kumar, Anjushree ; Gonzalez, Manuel ; Kenan, Anna ; Qaqish, Ibrahim ; Alexander, Kyrstin

Membranous nephropathy (MN) is a major cause of nephrotic syndrome, and neural epidermal growth factor-like 1 protein (NELL1) is the second most common inciting antigen. An increasing number of exposures and diseases have been associated with NELL1⁺ MN. There are limited data on NELL1 following kidney transplantation with only 1 previously reported case. In this report, we describe 3 cases of recurrent and 3 cases of de novo NELL1⁺ MN. None of the patients in this series had known triggers of MN, such as malignancy or associated medications (including lipoic acid, bucillamine, tiotropin, or indigenous medicines). This suggests that NELL1, although not a podocyte antigen, may present as an idiopathic disease or transplantation may serve as an exposure for the development of NELL1⁺ MN.

01 Jan 2025·INTERNAL MEDICINE

Bucillamine-induced Yellow Nail Syndrome with Chylothorax: A Case Report

Article

Author: Hisamoto, Yukari ; Utsunomiya, Toshiaki ; Murakawa, Keita ; Kakugawa, Tomoyuki ; Matsunaga, Kazuto ; Yamaji, Yoshikazu ; Oishi, Keiji ; Narikiyo, Koji ; Ohata, Syuichiro ; Edakuni, Nobutaka ; Yonezawa, Kosei ; Asami-Noyama, Maki ; Matsuda, Kazuki ; Hamada, Kazuki ; Hirano, Tsunahiko ; Kobayashi, Taiga ; Murata, Yoriyuki

Yellow nail syndrome (YNS), a rare condition characterized by thickened yellow nails, lymphedema, and respiratory manifestations, is rarely caused by bucillamine, an anti-rheumatic agent. Respiratory manifestations of YNS include chylothorax in 18.8%-22% of patients with pleural effusion. We herein report the first case of bucillamine-induced YNS with chylothorax. Lymphangiography revealed narrowing of the lymphatic vessels and stagnation of the lymphatic fluid, suggesting impaired lymphatic drainage. The chylothorax persisted despite the discontinuation of bucillamine. The present case illustrates that bucillamine can cause irreversible lymphatic impairment and chylothorax.

19 Sep 2024·Cureus Journal of Medical Science

Pharmaceutical Interventions for the Management of Hemorrhagic Shock in Hepatic Surgery: An Experimental Swine Model Outcome

Article

Author: Vassiliu, Panteleimon ; Tiniakos, Dina G ; Nomikos, Tzortzis ; Smyrniotis, Vassilios ; Papalois, Apostolos E ; Kougia, Ilianna I ; Arkadopoulos, Nikolaos

Introduction During abdominal trauma or major hepatic surgery, the liver can be subjected to hypoxic conditions due to hemorrhage, leading to various degrees of ischemic injury to hepatocytes. Hemorrhagic shock, a critical and life-threatening condition, often complicates hepatic surgery due to massive blood loss, resulting in inadequate tissue perfusion and oxygenation. The challenge in managing hemorrhagic shock in hepatic surgery is heightened by the liver's unique blood supply and its crucial role in coagulation. Effective treatment requires a multifaceted approach, including surgical intervention, blood transfusions, and pharmaceutical therapy to stabilize hemodynamics and promote coagulation. Additionally, reperfusion of the liver after resuscitation can cause severe injury through inflammatory and oxidative pathways, potentially leading to multiple organ dysfunction. This study examines the effectiveness of combining standard fluid therapy with antioxidants (bucillamine and valproic acid) in mitigating oxidative stress and reducing hepatocyte damage in the context of hemorrhagic shock. Method Thirty male swine were randomly divided into four groups as follows: Group A (n=6/control group), Group B (n=8), Group C (n=8), and Group D (n=8). A resection of the left liver lobe was performed, followed by the controlled loss of a specific volume of blood until the mean arterial pressure dropped to between 30 and 40 mmHg. The animals were maintained in this state of hypovolemic shock for 50 minutes, followed by IV administration of fluids. Additionally, pharmaceutical agents were administered to Groups B (bucillamine), C (valproic acid), and D (combination of bucillamine and valproic acid). The experiment lasted six hours in total. Results The study showed that animals treated with pharmaceutical agents like bucillamine and valproic acid and their combination demonstrated significantly reduced serum levels of protein carbonyls (PCs) and thiobarbituric acid reactive substances (TBARS) compared to the control group. Furthermore, histological evaluation of liver tissues revealed that treated animals showed reduced histopathological signs of injury, suggesting that the pharmaceutical agents not only lowered biochemical markers of oxidative stress but also provided a protective effect against liver damage in the context of hemorrhagic shock. Conclusion These findings suggest that incorporating antioxidant therapy into resuscitation protocols may offer substantial benefits in mitigating hepatic damage associated with hemorrhagic shock. This approach could potentially improve outcomes in clinical settings where oxidative stress plays a critical role in injury progression by better understanding the pathophysiology of this complex and dynamic process.

News (Medical) associated with Bucillamine

15 Apr 2025

·www.globenewswire.com

Revive Therapeutics to Investigate Bucillamine’s Potential in Cancer Treatment

April 10, 2025 -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for infectious diseases, rare disorders, and medical countermeasures, announced today that it has been contacted by a prominent clinical researcher from a U.S. University Cancer Institute. The researcher aims to investigate Bucillamine’s potential as a cancer treatment, particularly for boosting anti-tumor effects in patients with advanced solid tumors. This evaluation of Bucillamine in solid tumors would be integrated into a broader study, supported by funding from the NIH and/or other government entities. This proposed research builds on our strategy of evaluating novel uses of Bucillamine in academic and government supporting studies, including the partnership with Defence R&D Canada – Suffield Research Centre, an agency of the Canadian Department of National Defence, evaluating Bucillamine as a potential treatment for nerve agent exposure. Results from this study are expected shortly. Numerous nucleic acid-based therapies are under development for treating patients with advanced solid tumors. The high death rates linked to these cancers, both in the United States and worldwide, underscore the urgent need for better treatment options. Delivering external nucleic acid-based agents into the tumor microenvironment (“TME”) offers a promising approach to achieving targeted and powerful anti-tumor effects. The TME is marked by low oxygen levels and elevated reduced glutathione, which can destabilize drugs through nanoparticle breakdown in acidic or oxygen-deprived conditions. Additionally, various obstacles hinder both viral and non-viral delivery methods from effectively reaching the TME and releasing their therapeutic cargo. Adjusting the TME’s permeability or retention properties has been proposed as a way to boost the uptake of nucleic acid drugs given systemically, and the influence of these factors on patient outcomes in solid tumor cases remains a key focus of research.1 It is suggested that Bucillamine, a potential non-toxic supplement to certain solid tumor treatments, could act as a thiol donor to neutralize reactive oxygen species, replenish the reduced glutathione in the TME, and thereby amplify antitumor effects, presenting a potential application for this compound. Michael Frank, CEO of Revive, commented: “We look forward to collaborating with a top U.S. cancer institute to investigate Bucillamine’s potential for solid tumors, confirming its anti-inflammatory and antioxidant effects, since inflammation and oxidative stress are recognized contributors to cancer initiation and growth.” Revive Therapeutics is a life sciences company focused on the research and development of therapeutics for infectious diseases and medical countermeasures. Revive prioritizes its drug development efforts to take advantage of several regulatory incentives awarded by the FDA, such as Emergency Use Authorization, Orphan Drug, Fast Track, and Breakthrough Therapy designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of nerve agent exposure and long COVID. Revive is also advancing the development of Psilocybin-based therapeutics through various programs. For more information, visit www.ReviveThera.com. Source: Huayamares SG, Loughrey D, Kim H, Dahlman JE, Sorscher EJ. Nucleic acid-based drugs for patients with solid tumours. Nat Rev Clin Oncol. 2024 Jun;21(6):407-427. doi: 10.1038/s41571-024-00883-1. Epub 2024 Apr 8. PMID: 38589512. The content above comes from the network. if any infringement, please contact us to modify.

Orphan DrugFast TrackClinical Study

01 Apr 2025

·www.globenewswire.com

Revive Therapeutics Announces Acquisition of Molecular Hydrogen Program

TORONTO, April 01, 2025 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for infectious diseases, rare disorders, and medical countermeasures, is pleased to announce that further to its press release dated March 3, 2025, it has entered into an asset purchase agreement (the “Agreement”) dated March 31, 2025 with DiagnaMed Holdings Corp. (CSE: DMED) (OTCQB: DGNMF) (“DiagnaMed”) to acquire the full rights to DiagnaMed’s intellectual property (the “Acquired Assets”) pertaining to molecular hydrogen as potential treatments for neurological and mental health disorders (the “Acquisition”). Pursuant to the Agreement, the consideration for the Acquired Assets will be satisfied through the issuance to DiagnaMed of one million common shares of Revive, at an issue price of $0.05 per share, representing a purchase price of $50,000. The issuance of the common shares is subject to regulatory approvals, including the CSE, and will be subject to restrictions on resale under applicable securities laws. There are no further financial terms, including milestones, royalties or other monetary obligation payments pursuant to the Agreement. The Acquired Assets will include all of the following: Provisional patent application with the U.S. Patent and Trademark Office outlining pharmaceutical-based methods and compositions for producing molecular hydrogen as potential treatments for neurological and mental health disorders. The patent application, entitled “Methods and Compositions for Producing Hydrogen for Treating Diseases and Disorders Affecting Brain Health,” outlines novel combinations of certain pharmaceutical-grade hydrogen producing ingredients as a potential therapeutic option for a variety of neurological disorders such as, but not limited to, Dementia, Parkinson’s disease, and Traumatic brain injury, and mental health disorders including, Depression, Anxiety, and Post-traumatic stress disorder (press release).All intellectual and work property derived from DiagnaMed’s research activities in amyotrophic lateral sclerosis (ALS) and its Orphan Drug Designation (ODD) for molecular hydrogen in the treatment of ALS by the U.S. Food and Drug Administration (FDA). Michael Frank, CEO of Revive, commented: “This acquisition expands Revive’s pipeline to brain disorders. Molecular hydrogen may offer a potential therapeutic option for neurological and mental health disorders. The orphan drug designation granted by the FDA for molecular hydrogen in ALS offers hope to patients and families impacted by this debilitating illness. We are committed to collaborating with leading ALS researchers, patient advocacy groups, and regulatory experts to ensure a rigorous and expedited path toward potential approval.” ALS is a progressive neuromuscular disease that attacks nerve cells responsible for controlling voluntary muscle movement, leading to paralysis and, ultimately, respiratory failure, and has a life expectancy of only two to six years after diagnosis. Currently, there is no known cure for ALS. ALS affects approximately 50,000 people in the U.S. and Europe, with over 5,000 new cases diagnosed annually. With limited treatment options available, the FDA’s recognition of molecular hydrogen as an orphan drug offers hope to patients and families impacted by this debilitating illness. Molecular hydrogen, a small molecule with antioxidant and anti-inflammatory properties, has shown early promise in preclinical studies for its ability to mitigate oxidative stress and inflammation—key factors implicated in ALS progression. The FDA’s decision paves the way for Revive to accelerate its development programs with molecular hydrogen. About Revive Therapeutics Ltd. Revive Therapeutics is a life sciences company focused on the research and development of therapeutics for infectious diseases and medical countermeasures. Revive prioritizes its drug development efforts to take advantage of several regulatory incentives awarded by the FDA, such as Emergency Use Authorization, Orphan Drug, Fast Track, and Breakthrough Therapy designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of nerve agent exposure and long COVID. Revive is also advancing the development of Psilocybin and molecular hydrogen therapeutics through various programs. For more information, visit www.ReviveThera.com. For more information, please contact: Michael FrankChief Executive OfficerRevive Therapeutics Ltd.Tel: 1 888 901 0036Email: mfrank@revivethera.comWebsite: www.revivethera.com Neither the Canadian Securities Exchange nor its Regulation Services Provider has reviewed or accepts responsibility for the adequacy or accuracy of this release. Cautionary Statement This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “may”, “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the Company’s cannabinoids, psychedelics and infectious diseases programs. Forward-looking information is based on reasonable assumptions that have been made by Revive at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company's management's discussion and analysis for the three and six months ended December 31, 2024 ("MD&A"), dated February 24, 2025, which is available on the Company's profile at www.sedarplus.ca.

Orphan DrugFast TrackAcquisition

12 Nov 2024

·www.globenewswire.com

Revive Therapeutics Announces Publication Demonstrating Novel Therapeutic Approach of Psilocybin in Stroke

TORONTO, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for infectious diseases, medical countermeasures and rare disorders, today announced the publication of a scientific article demonstrating the potential of psilocybin as a novel therapeutic approach in stroke. The publication, entitled, “Neuroprotective effects of psilocybin in a rat model of stroke,” is published in BMC Neuroscience and is available here. The research and intellectual property were part of the acquisition of assets from PharmaTher Holdings Ltd (CSE: PHRM) (OTCQB: PHRRF) in February 2021. The research study supported the Company’s PCT application (PCT/CA2021/050360), titled, “Use of Psilocybin in the Treatment of Neurological Brain Injury and Migraines.” The objective of the research study was to determine the protective effect of psilocybin in cellular and animal models of stroke. In the study, psilocybin reduced brain infarction and improved locomotor behavior in stroke rats; the protective mechanisms involve regulating BDNF expression. Michael Frank, CEO of Revive, commented: “We have a diverse psilocybin-based pharmaceutical program that has been quietly moving forward with the aim of treating neurological, mental health and substance abuse disorders. The publication of the research study demonstrating psilocybin’s therapeutic potential in the treatment of stroke, which is often associated with subsequent depression, validates our strategic initiative to focus on evaluating psilocybin in clinical studies and novel delivery methods, such as our in-development psilocybin oral thin-film and microneedle patch.” About Revive Therapeutics Ltd. Revive Therapeutics is a life sciences company focused on the research and development of therapeutics and diagnostics for infectious diseases, medical countermeasures, and rare disorders. Revive prioritizes its drug development efforts to take advantage of several regulatory incentives awarded by the FDA, such as Emergency Use Authorization, Orphan Drug, Fast Track, and Breakthrough Therapy designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of nerve agent exposure and long COVID. Revive is also advancing the development of Psilocybin-based therapeutics through various programs. For more information, visit www.ReviveThera.com. For more information, please contact: Michael FrankChief Executive OfficerRevive Therapeutics Ltd.Tel: 1 888 901 0036Email: mfrank@revivethera.comWebsite: www.revivethera.com Neither the Canadian Securities Exchange nor its Regulation Services Provider has reviewed or accepts responsibility for the adequacy or accuracy of this release. Cautionary Statement This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “may”, “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the Company’s cannabinoids, psychedelics and infectious diseases programs. Forward-looking information is based on reasonable assumptions that have been made by Revive at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company's management's discussion and analysis for the year ended June 30, 2024 ("MD&A"), dated October 25, 2024, which is available on the Company's profile at www.sedarplus.ca.

Orphan DrugFast Track

100 Deals associated with Bucillamine

External Link

KEGG	Wiki	ATC	Drug Bank
D01809	Bucillamine	M01CC02	DB12160

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Rheumatoid Arthritis	Japan	AYUMI Pharmaceutical Corp.	30 Jun 1987

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 3	United States	Revive Therapeutics Ltd.	27 Nov 2020
COVID-19	Phase 3	Puerto Rico	Revive Therapeutics Ltd.	27 Nov 2020
Cystinuria	Phase 2	United States	Revive Therapeutics Ltd.	01 May 2017
Primary gout	Phase 2	United States	Revive Therapeutics Ltd.	01 Apr 2015
Reperfusion Injury	Phase 2	-	Revive Therapeutics Ltd.	-
Hepatitis, Autoimmune	IND Application	United States	Revive Therapeutics Ltd.	19 Jul 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04504734 (Corporate Publications) Manual	Phase 3	COVID-19	713	Bucillamine	-	Negative	06 Jul 2023
				placebo	ceuktwbwjb(miffcesord) = ffazsvkwum okfzhqwjwh (azlkokcsru ) Not Met
ACR2013	Not Applicable	Rheumatoid Arthritis HLA-DRB108:02 \| DQB104:02	485	Bucillamine (HLA-DRB1*08:02)	rbfwhdwynb(bvczeowftj): P-Value = 1.09X10-6	Positive	25 Oct 2013
				Bucillamine (DQB1*04:02)
EULAR2010	Not Applicable	Rheumatoid Arthritis	835	Bucillamine	xvutafhpja(qdholppwpn) = pzkcrmrnhr qegulnjhxv (ofzgqzoger ) View more	-	16 Jun 2010
EULAR2005	Not Applicable	Rheumatoid Arthritis CD34+	8	Bucillamine	mepjnagdne(elpubhdkbr) = ewqokufulu mlmefbajob (etpwgjjuxk, 2.33) View more	-	08 Jun 2005
				Methotrexate	mepjnagdne(elpubhdkbr) = icywneiywx mlmefbajob (etpwgjjuxk, 4.80) View more

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