Infections and Infectious Diseases | IND Enabling Drugs | UNITED STATES

Ampio Pharmaceuticals

Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

United States

Post An Enquiry

Virtual Booth

ISPE Manufacturing

Participation Not Confirmed

Update your events

Ampio Provides Update on COVID-19 Program

Lead Product(s): Ampion

Therapeutic Area: Infections and Infectious Diseases

Highest Development Status: IND Enabling Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 22, 2020

Details:

Ampio has filed Investigative New Drug ("IND") applications for Ampion™ with the FDA and has maintained ongoing dialog with the FDA regarding the Company's development of treatment options which includes inhalation and intravenous applications for COVID-19 affected patients.

BioSig Technologies

Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

United States

Post An Enquiry

Virtual Booth

ISPE Manufacturing

Participation Not Confirmed

Update your events

ViralClear Closes $10.8 Million Equity Financing for Development of COVID-19 Broad-Spectrum Oral Anti-Viral Candidate Merimepodib

Lead Product(s): Merimepodib,Remdesivir

Therapeutic Area: Infections and Infectious Diseases

Highest Development Status: IND Enabling Product Type: Small molecule

Partner/Sponsor/Collaborator: Laidlaw & Company

Deal Size: $10.8 million Upfront Cash: Undisclosed

Deal Type: Financing May 20, 2020

Details:

ViralClear plans to use the proceeds of this offering for the development, including phase II human clinical trials, of its product candidate merimepodib, a broad-spectrum anti-viral agent.

BioSig Technologies

Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

United States

Post An Enquiry

Virtual Booth

ISPE Manufacturing

Participation Not Confirmed

Update your events

FDA Clears the IND Application to Enable the Phase II Trial of ViralClear’s Merimepodib to Treat Advanced COVID-19

Lead Product(s): Merimepodib,Remdesivir

Therapeutic Area: Infections and Infectious Diseases

Highest Development Status: IND Enabling Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 18, 2020

Details:

The FDA informed ViralClear that it may proceed with a proposed phase II study of merimepodib oral solution in adults with COVID-19 who are hospitalized and either require supplemental oxygen or are on non-invasive ventilation or high flow oxygen devices.

Cocrystal Pharma

Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

United States

Post An Enquiry

Virtual Booth

ISPE Manufacturing

Participation Not Confirmed

Update your events

Cocrystal Pharma Provides COVID-19 Impact Update on Development Programs

Lead Product(s): CC-42344

Therapeutic Area: Infections and Infectious Diseases

Highest Development Status: IND Enabling Product Type: Undisclosed

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 11, 2020

Details:

The Company’s lead molecule in development, CC-42344, is currently being evaluated in preclinical IND-enabling studies for the treatment of influenza. CC-42344 has shown excellent antiviral activity against influenza A strains.

Mateon Therapeutics

Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

United States

Post An Enquiry

Virtual Booth

ISPE Manufacturing

Participation Not Confirmed

Update your events

Mateon Announces the Filing of an IND with US FDA to Evaluate its Antisense Drug Candidate OT-101 in COVID-19 patients

Lead Product(s): Trabedersen

Therapeutic Area: Infections and Infectious Diseases

Highest Development Status: IND Enabling Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 27, 2020

Details:

The proposed randomized, double-blind, placebo-controlled Phase 2 study is intended to evaluate the safety and efficacy of OT-101 in adult patients hospitalized with COVID-19 and pneumonia in the US.

BioSig Technologies

Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

United States

Post An Enquiry

Virtual Booth

ISPE Manufacturing

Participation Not Confirmed

Update your events

BioSig Subsidiary ViralClear Submits Investigational New Drug Application to the FDA for Phase II Clinical Trials for Merimepodib

Lead Product(s): Merimepodib

Therapeutic Area: Infections and Infectious Diseases

Highest Development Status: IND Enabling Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 24, 2020

Details:

The study will be a randomized, placebo-controlled trial to evaluate the efficacy and safety of Merimepodib in COVID-19 patients. In vitro studies show decrease of viral production by over 98%.

Caladrius Biosciences

Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

United States

Post An Enquiry

Virtual Booth

ISPE Manufacturing

Participation Not Confirmed

Update your events

Caladrius Biosciences Plans to Assess its CLBS119 Cell Therapy for Repair of COVID-19 Induced Lung Damage

Lead Product(s): CLBS119

Therapeutic Area: Infections and Infectious Diseases

Highest Development Status: IND Enabling Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 23, 2020

Details:

U.S. Food and Drug Administration has authorized its investigational new drug application for the study of CLBS119, a CD34+ cell therapy for repair of COVID-19 induced lung damage.

aTyr Pharma

Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

United States

Post An Enquiry

Virtual Booth

ISPE Manufacturing

Participation Not Confirmed

Update your events

FDA Accepts IND Application of ATyr Pharma on Phase 2 Study For COVID-19

Lead Product(s): ATYR1923

Therapeutic Area: Infections and Infectious Diseases

Highest Development Status: IND Enabling Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 21, 2020

Details:

Phase 2 clinical trial will be a randomized, double blind, placebo-controlled study with ATYR1923 in 30 confirmed COVID-19 positive patients at up to 10 centers in the United States.

Alexion Pharmaceuticals

Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

United States

Post An Enquiry

Virtual Booth

ISPE Manufacturing

Participation Not Confirmed

Update your events

Alexion Preps Phase 3 Study of Ultomiris in Severe COVID-19

Lead Product(s): Ravulizumab

Therapeutic Area: Infections and Infectious Diseases

Highest Development Status: IND Enabling Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 20, 2020

Details:

Study will evaluate the impact of ULTOMIRIS, a biologic medicine, on survival, duration of mechanical ventilation, and hospital stay compared to best supportive care.

7 Hills Pharma

Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

United States

Post An Enquiry

Virtual Booth

ISPE Manufacturing

Participation Not Confirmed

Update your events

7 Hills Pharma Announces FDA Clearance of Investigational New Drug Application for 7HP349, a First-in-Class Immune Stimulant

Lead Product(s): 7HP349

Therapeutic Area: Infections and Infectious Diseases

Highest Development Status: IND Enabling Product Type: Vaccine

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 14, 2020

Details:

U.S. FDA has cleared the company’s investigational new drug application for 7HP349. The FDA completed its 30-day safety review and granted approval to proceed with Phase 1 healthy volunteer study.

Find

Find FDA Investigational New Drug (IND) Submissions for Infections and Infectious Diseases in UNITED STATES

United States

A collaboration with SCORR Marketing

Product Type

Companies

Ampio Pharmaceuticals

Ampio Provides Update on COVID-19 Program

BioSig Technologies

ViralClear Closes $10.8 Million Equity Financing for Development of COVID-19 Broad-Spectrum Oral Anti-Viral Candidate Merimepodib

BioSig Technologies

FDA Clears the IND Application to Enable the Phase II Trial of ViralClear’s Merimepodib to Treat Advanced COVID-19

Cocrystal Pharma

Cocrystal Pharma Provides COVID-19 Impact Update on Development Programs

Mateon Therapeutics

Mateon Announces the Filing of an IND with US FDA to Evaluate its Antisense Drug Candidate OT-101 in COVID-19 patients

BioSig Technologies

BioSig Subsidiary ViralClear Submits Investigational New Drug Application to the FDA for Phase II Clinical Trials for Merimepodib

Caladrius Biosciences

Caladrius Biosciences Plans to Assess its CLBS119 Cell Therapy for Repair of COVID-19 Induced Lung Damage

aTyr Pharma

FDA Accepts IND Application of ATyr Pharma on Phase 2 Study For COVID-19

Alexion Pharmaceuticals

Alexion Preps Phase 3 Study of Ultomiris in Severe COVID-19

7 Hills Pharma

7 Hills Pharma Announces FDA Clearance of Investigational New Drug Application for 7HP349, a First-in-Class Immune Stimulant