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Details:
Revive Therapeutics and Indian specialty pharma firm, Supriya Lifescience have signed an MOU to pursue the manufacturing of the API, conduct clinical registration, and commercialize Bucillamine in the treatment of mild-to-moderate COVID-19 in India.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Revive Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration June 08, 2021
Details:
Bucillamine is an oral potent thiol donor small molecule drug, which is being evaluated in phase 3 clinical trials for the treatment of Covid-19 infection.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 27, 2024
Details:
Bucillamine is an oral potent thiol donor small molecule drug, which is being evaluated in phase 3 clinical trials for the treatment of Covid-19 infection.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 19, 2024
Details:
The company intends to use the net proceeds of the offering for clinical development of Bucillamine, which is an antirheumatic agent developed from tiopronin for the treatment of long-term COVID-19.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Hampton Securities Limited
Deal Size: $2.1 million Upfront Cash: Undisclosed
Deal Type: Private Placement February 26, 2024
Details:
The net proceeds will be used for the clinical development of a bucillamine, which is a thiol-based drug with anti-inflammatory and antiviral properties a potential treatment for long-term COVID disease.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Canaccord Genuity Corp
Deal Size: $0.9 million Upfront Cash: Undisclosed
Deal Type: Private Placement January 31, 2024
Details:
The company intends to use the net proceeds to advance bucillamine, a small molecule prescribed in the treatment of rheumatoid arthritis in Japan and South Korea, for clinical work on long COVID and other possible indications.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $3.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement January 24, 2024
Details:
Bucillamine is a potent antioxidant and anti-inflammatory, small molecule drug candidate. It is being evaluated for the treatment of nerve agent induced brain injury seizure.
Lead Product(s): Bucillamine,Acetylcysteine
Therapeutic Area: Trauma (Emergency, Injury, Surgery) Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 16, 2024
Details:
Bucillamine is an oral potent thiol donor small molecule drug, which is being evaluated in phase 3 clinical trials for the treatment of Covid-19 infection.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 10, 2024
Details:
The collaboration aims for the clinical and commercial development of Revive’s lyophilized formulation of Bucillamine, a potent antioxidant and anti-inflammatory and may be helpful for orphan indications in rare inflammatory disorders such as ischemia-reperfusion injury.
Lead Product(s): Bucillamine
Therapeutic Area: Trauma (Emergency, Injury, Surgery) Product Name: Undisclosed
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Attwill Medical Solutions
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration December 18, 2023
Details:
The agreement aims to evaluate Bucillamine, a significantly more effective antioxidant than n-acetylcysteine, as a potential treatment for nerve agent exposure.
Lead Product(s): Bucillamine
Therapeutic Area: Trauma (Emergency, Injury, Surgery) Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Defence R&D Canada
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement October 17, 2023
Details:
Bucillamine (N-(mercapto-2-methylpropionyl)-l-cysteine), prescribed for rheumatoid arthritis, has vastly superior function in restoring glutathione and potential to prevent acute lung injury during influenza infection. The drug is being investigated for COVID-19 indication.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 06, 2023
Details:
Bucillamine (N-(mercapto-2-methylpropionyl)-l-cysteine), prescribed for rheumatoid arthritis, has vastly superior function in restoring glutathione and potential to prevent acute lung injury during influenza infection. The drug is being investigated for COVID-19 indication.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 30, 2023
Details:
Bucillamine (N-(mercapto-2-methylpropionyl)-l-cysteine) rapidly enters cells and normally transports the amino acid cysteine, demostrating anti-inflammatory action and is being investigated for COVID-19 indication.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 12, 2023
Details:
Bucillamine (N-(mercapto-2-methylpropionyl)-l-cysteine), prescribed for rheumatoid arthritis, has vastly superior function in restoring glutathione and potential to prevent acute lung injury during influenza infection. The drug is being investigated for COVID-19 indication.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 02, 2023
Details:
Bucillamine (N-(mercapto-2-methylpropionyl)-l-cysteine), prescribed for rheumatoid arthritis, has vastly superior function in restoring glutathione and potential to prevent acute lung injury during influenza infection. The drug is being investigated for COVID-19 indication.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 18, 2023
Details:
Bucillamine (N-(mercapto-2-methylpropionyl)-l-cysteine), prescribed for rheumatoid arthritis, has vastly superior function in restoring glutathione and potential to prevent acute lung injury during influenza infection. The drug is being investigated for COVID-19 indication.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 20, 2023
Details:
Bucillamine study evaluated the potential disruption of the SARS-CoV-2 virus spike protein by various FDA-approved mild anti-oxidants, which has shown that Bucillamine had the most potent effect on COVID-19 Omicron variants.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 19, 2023
Details:
Revive Therapeutics is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $4.3 million Upfront Cash: Undisclosed
Deal Type: Private Placement January 12, 2023
Details:
Bucillamine study evaluated the potential disruption of the SARS-CoV-2 virus spike protein by various FDA-approved mild anti-oxidants, which has shown that Bucillamine had the most potent effect on COVID-19 Omicron variants.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 12, 2023
Details:
Bucillamine is a cysteine derivative with 2 thiol groups that is 16-fold more potent than NAC as a thiol donor in vivo, giving it vastly superior function in restoring glutathione and therefore greater potential to prevent acute lung injury during influenza infection.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 09, 2023
Details:
Bucillamine (N-(mercapto-2-methylpropionyl)-l-cysteine), prescribed for rheumatoid arthritis, has vastly superior function in restoring glutathione and potential to prevent acute lung injury during influenza infection. The drug is being investigated for COVID-19 indication.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 05, 2023
Details:
Bucillamine is an orally bioavailable derivative of the endogenous amino acid cysteine with two donatable thiol groups, with potential antioxidant and anti-inflammatory activities.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 22, 2022
Details:
Bucillamine is an orally bioavailable derivative of the endogenous amino acid cysteine with two donatable thiol groups, with potential antioxidant and anti-inflammatory activities.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: EMD Financial
Deal Size: $3.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement December 15, 2022
Details:
Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 24, 2022
Details:
Bucillamine, an oral drug with anti-inflammatory and antiviral properties, for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 14, 2022
Details:
Bucillamine, cysteine derivative is oral anti-inflammatory drug under investigation to treat adults with COVID-19 in outpatient setting and has to mitigate effects of proinflammatory reactive oxygen species and prevent acute lung injury during respiratory infections.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 14, 2022
Details:
Bucillamine, (N-(mercapto-2-methylpropionyl)-l-cysteine) an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 16, 2022
Details:
Article described, antibody level were significantly lower in group treated with TNF inhibitor with methotrexate, abatacept, mycophenolate mofetil , MMF or mizoribine combined with calcineurin inhibitor, and rituximab or cyclophosphamide compared to those with Bucillamine.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 18, 2022
Details:
The ODD validates strategy in pursuing novel uses of Bucillamine, a cysteine derivative reactivating this endogenous defense against oxidant injury for rare disorders and life-threatening conditions, including infectious diseases and preventing IRI.
Lead Product(s): Bucillamine
Therapeutic Area: Trauma (Emergency, Injury, Surgery) Product Name: Undisclosed
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 15, 2022
Details:
701 subjects dosed to date in Phase 3 trial of Bucillamine, an oral drug with anti-inflammatory and antiviral properties is on-track to complete study enrollment in Q1-2022 and FDA submission thereafter.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Delta Health
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 18, 2022
Details:
Approximately 700 subjects participated in the enrollment period of Phase 3 Clinical Trial for Bucillamine, to evaluate the safety and efficacy of oral drugs with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 06, 2022
Details:
As a result of the Company’s plans to diversify its patient population globally, incorporate viral load and anti-inflammatory markers, and its ongoing discussions with international pharmaceutical companies seeking to obtain rights to Bucillamine as a treatment for COVID-19.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 29, 2021
Details:
Expanding the potential of Bucillamine as an effective treatment for Omicron variant, also shown to inhibit SARS-CoV-2 infection in vitro for the Delta variant.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 03, 2021
Details:
Revive believes the use of Bucillamine during liver transplantation has the potential to be a safe and effective approach to address the unmet medical need for a novel strategy to limit or prevent ischemia–reperfusion injury (IRI) during liver transplantation.
Lead Product(s): Bucillamine
Therapeutic Area: Trauma (Emergency, Injury, Surgery) Product Name: Undisclosed
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 23, 2021
Details:
The Company expects to eventually file an Emergency Use Authorization (“EUA”) with the FDA in the event that the blinded results provide evidence to the DSMB’s final review to recommend to pursue EUA for Bucillamine to treat mild to moderate COVID-19.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 26, 2021
Details:
The Company is continuing the Phase 3 clinical trial with the recent recommended 600 mg high dose as selected by the DSMB.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 15, 2021
Details:
The agreement will support research in the laboratory of Dr. John Fahy to test the efficacy of Bucillamine in pre-clinical models of COVID-19 and to design protocols that test the utility of Bucillamine in human trials.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: University of California
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement May 03, 2021
Details:
This is an open-label study to evaluate the safety, tolerability, pharmacokinetics and efficacy of surufatinib in combination with tislelizumab in patients with advanced solid tumors.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 24, 2021
Details:
The primary objective is to compare the frequency of hospitalization or death in patients with mild-moderate COVID-19 receiving Bucillamine with those receiving placebo.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 26, 2021
Details:
Revive Therapeutics is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19.
Lead Product(s): Bucillamine
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 11, 2021
Details:
The Phase 3 confirmatory clinical trial, will enroll up to 1,000 patients that will be randomized 1:1:1 to receive Bucillamine 100 mg three times a day (“TID”), Bucillamine 200 mg TID or placebo TID for up to 14 days.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 23, 2020
Details:
The Phase 3 confirmatory clinical trial titled, study will evaluate Bucillamine in Patients with Mild-Moderate COVID-19”, patients will be randomized 1:1:1 to receive Bucillamine 100 mg three times a day Bucillamine 200 mg TID or placebo TID for up to 14 days.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 29, 2020
Details:
The EAP for compassionate use is a multi-center, open label study of Bucillamine in hospitalized patients with severe COVID-19 and is being done to complement the Company’s Phase 3 COVID-19 study in the U.S.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 16, 2020
Details:
Company’s Phase 3 clinical trial protocol to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19 received approval from the independent Institutional Review Board ("IRB") at Advarra, a premier IRB services company in North America.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 31, 2020
Details:
U.S. FDA approval to proceed with the Company’s Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19, the Company has submitted its clinical trial protocol for independent Institutional Review Board approval.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 26, 2020
Details:
Revive Therapeutics has received FDA approval to proceed with the Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine in mild-moderate COVID-19. The company will now expand the Phase 3 clinical trials in Asia-Pacific Countries and Canada.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 19, 2020
Details:
The Memorandum of Understanding with between the companies aims to establish AMS as a resource for clinical packaging and distribution for the Revive's Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Revive Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement August 14, 2020
Details:
The Phase 3 confirmatory clinical study is a multi-center, randomized, double-blind, placebo-controlled study of bucillamine in patients with mild-moderate COVID-19.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 31, 2020
Details:
The Phase 3 confirmatory clinical will enroll up to 800 patients that will be randomized 1:1:1 to receive Bucillamine 100 mg three times a day, Bucillamine 200 mg TID or placebo TID for up to 14 days.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 30, 2020
Details:
Company has filed its Clinical Trial Application with Health Canada and provides an update on the filing of its IND package to the U.S. FDA for the proposed Phase 3 clinical trial to evaluate Bucillamine in the treatment of patients with mild-moderate COVID-19.
Lead Product(s): Bucillamine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 03, 2020
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Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
