[{"orgOrder":0,"company":"Harvard Apparatus Regenerative Technology","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Gastroenterology","country":"U.S.A","productType":"Undisclosed","year":"2020","type":"Not Applicable","leadProduct":"Cellspan Esophageal Implant","moa":"","graph1":"Gastroenterology","graph2":"IND Enabling","graph3":"Harvard Apparatus Regenerative Technology","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Gastroenterology","amount2New":0,"dosageForm":"","sponsorNew":"Harvard Apparatus Regenerative Technology \/ Not Applicable","highestDevelopmentStatusID":"5","companyTruncated":"Harvard Apparatus Regenerative Technology \/ Not Applicable"},{"orgOrder":0,"company":"Xiling Lab","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Gastroenterology","country":"","productType":"Small molecule","year":"2020","type":"Not Applicable","leadProduct":"SMP-100","moa":"5-HT3 receptor","graph1":"Gastroenterology","graph2":"IND Enabling","graph3":"Xiling Lab","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Gastroenterology","amount2New":0,"dosageForm":"Oral Solution","sponsorNew":"Xiling Lab \/ Not Applicable","highestDevelopmentStatusID":"5","companyTruncated":"Xiling Lab \/ Not Applicable"},{"orgOrder":0,"company":"Theriva Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Gastroenterology","country":"","productType":"Large molecule","year":"2020","type":"Not Applicable","leadProduct":"Recombinant bovine intestinal alkaline phosphatase","moa":"","graph1":"Gastroenterology","graph2":"IND Enabling","graph3":"Theriva Biologics","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Gastroenterology","amount2New":0,"dosageForm":"Oral","sponsorNew":"Theriva Biologics \/ Not Applicable","highestDevelopmentStatusID":"5","companyTruncated":"Theriva Biologics \/ Not Applicable"},{"orgOrder":0,"company":"Plakous Therapeutics","sponsor":"National Institutes of Health","pharmaFlowCategory":"D","therapeuticArea":"Gastroenterology","country":"","productType":"Large molecule","year":"2020","type":"Funding","leadProduct":"Protego-PD","moa":"","graph1":"Gastroenterology","graph2":"IND Enabling","graph3":"Plakous Therapeutics","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Gastroenterology","amount2New":0,"dosageForm":"Oral","sponsorNew":"Plakous Therapeutics \/ National Institute of Health","highestDevelopmentStatusID":"5","companyTruncated":"Plakous Therapeutics \/ National Institute of Health"},{"orgOrder":0,"company":"Theriva Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Gastroenterology","country":"","productType":"Large molecule","year":"2020","type":"Not Applicable","leadProduct":"Recombinant bovine intestinal alkaline phosphatase","moa":"","graph1":"Gastroenterology","graph2":"IND Enabling","graph3":"Theriva Biologics","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Gastroenterology","amount2New":0,"dosageForm":"Oral","sponsorNew":"Theriva Biologics \/ Not Applicable","highestDevelopmentStatusID":"5","companyTruncated":"Theriva Biologics \/ Not Applicable"},{"orgOrder":0,"company":"ISOThrive","sponsor":"Virginia Catalyst","pharmaFlowCategory":"D","therapeuticArea":"Gastroenterology","country":"","productType":"Large molecule","year":"2020","type":"Funding","leadProduct":"Maltosyl-isomaltooligosaccharide","moa":"","graph1":"Gastroenterology","graph2":"IND Enabling","graph3":"ISOThrive","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Gastroenterology","amount2New":0,"dosageForm":"","sponsorNew":"ISOThrive \/ Virginia Catalyst","highestDevelopmentStatusID":"5","companyTruncated":"ISOThrive \/ Virginia Catalyst"},{"orgOrder":0,"company":"Prometheus Biosciences","sponsor":"Eventide Asset Management","pharmaFlowCategory":"D","therapeuticArea":"Gastroenterology","country":"","productType":"Large molecule","year":"2020","type":"Financing","leadProduct":"PRA023","moa":"","graph1":"Gastroenterology","graph2":"IND Enabling","graph3":"Prometheus Biosciences","amount2":0.13,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Gastroenterology","amount2New":0.13,"dosageForm":"","sponsorNew":"Prometheus Biosciences \/ Eventide Asset Management","highestDevelopmentStatusID":"5","companyTruncated":"Prometheus Biosciences \/ Eventide Asset Management"},{"orgOrder":0,"company":"PPD","sponsor":"First Wave BioPharma","pharmaFlowCategory":"D","therapeuticArea":"Gastroenterology","country":"","productType":"Small molecule","year":"2021","type":"Collaboration","leadProduct":"Niclosamide","moa":"Wnt signaling","graph1":"Gastroenterology","graph2":"IND Enabling","graph3":"PPD","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Gastroenterology","amount2New":0,"dosageForm":"oral immediate-release tablet","sponsorNew":"PPD \/ AzurRx BioPharma","highestDevelopmentStatusID":"5","companyTruncated":"PPD \/ AzurRx BioPharma"},{"orgOrder":0,"company":"MitoImmune Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Gastroenterology","country":"","productType":"Small molecule","year":"2021","type":"Not Applicable","leadProduct":"MIT-001","moa":"","graph1":"Gastroenterology","graph2":"IND Enabling","graph3":"MitoImmune Therapeutics","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Gastroenterology","amount2New":0,"dosageForm":"","sponsorNew":"MitoImmune Therapeutics \/ Not Applicable","highestDevelopmentStatusID":"5","companyTruncated":"MitoImmune Therapeutics \/ Not Applicable"},{"orgOrder":0,"company":"Giiant pharma","sponsor":"Amplitude Ventures","pharmaFlowCategory":"D","therapeuticArea":"Gastroenterology","country":"","productType":"Small molecule","year":"2021","type":"Financing","leadProduct":"GT-2108","moa":"PDE4","graph1":"Gastroenterology","graph2":"IND Enabling","graph3":"Giiant pharma","amount2":0.01,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Gastroenterology","amount2New":0.01,"dosageForm":"Oral","sponsorNew":"Giiant pharma \/ Amplitude Ventures","highestDevelopmentStatusID":"5","companyTruncated":"Giiant pharma \/ Amplitude Ventures"},{"orgOrder":0,"company":"Giiant pharma","sponsor":"Amplitude Ventures","pharmaFlowCategory":"D","therapeuticArea":"Gastroenterology","country":"","productType":"Small molecule","year":"2021","type":"Financing","leadProduct":"GT-2108","moa":"PDE4","graph1":"Gastroenterology","graph2":"IND Enabling","graph3":"Giiant pharma","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Gastroenterology","amount2New":0.01,"dosageForm":"Oral","sponsorNew":"Giiant pharma \/ Amplitude Ventures","highestDevelopmentStatusID":"5","companyTruncated":"Giiant pharma \/ Amplitude Ventures"},{"orgOrder":0,"company":"OnQuality Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Gastroenterology","country":"","productType":"Small molecule","year":"2022","type":"Not Applicable","leadProduct":"OQL051","moa":"CDK-4","graph1":"Gastroenterology","graph2":"IND Enabling","graph3":"OnQuality Pharma","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Gastroenterology","amount2New":0,"dosageForm":"","sponsorNew":"OnQuality Pharma \/ Not Applicable","highestDevelopmentStatusID":"5","companyTruncated":"OnQuality Pharma \/ Not Applicable"},{"orgOrder":0,"company":"Ossium Health","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Gastroenterology","country":"","productType":"Cell and Gene therapy","year":"2022","type":"Not Applicable","leadProduct":"Mesenchymal Stem Cell","moa":"","graph1":"Gastroenterology","graph2":"IND Enabling","graph3":"Ossium Health","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Gastroenterology","amount2New":0,"dosageForm":"","sponsorNew":"Ossium Health \/ Not Applicable","highestDevelopmentStatusID":"5","companyTruncated":"Ossium Health \/ Not Applicable"},{"orgOrder":0,"company":"Noveome Biotherapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Gastroenterology","country":"","productType":"Cell and Gene therapy","year":"2022","type":"Not Applicable","leadProduct":"ST266","moa":"","graph1":"Gastroenterology","graph2":"IND Enabling","graph3":"Noveome Biotherapeutics","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Gastroenterology","amount2New":0,"dosageForm":"Injectable\/Injection","sponsorNew":"Noveome Biotherapeutics \/ Not Applicable","highestDevelopmentStatusID":"5","companyTruncated":"Noveome Biotherapeutics \/ Not Applicable"},{"orgOrder":0,"company":"Prometheus Biosciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Gastroenterology","country":"","productType":"Large molecule","year":"2022","type":"Not Applicable","leadProduct":"PRA052","moa":"CD30","graph1":"Gastroenterology","graph2":"IND Enabling","graph3":"Prometheus Biosciences","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Gastroenterology","amount2New":0,"dosageForm":"","sponsorNew":"Prometheus Biosciences \/ Not Applicable","highestDevelopmentStatusID":"5","companyTruncated":"Prometheus Biosciences \/ Not Applicable"},{"orgOrder":0,"company":"Zhiyi Biotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Gastroenterology","country":"","productType":"Large molecule","year":"2022","type":"Not Applicable","leadProduct":"SK10","moa":"","graph1":"Gastroenterology","graph2":"IND Enabling","graph3":"Zhiyi Biotech","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Gastroenterology","amount2New":0,"dosageForm":"","sponsorNew":"Zhiyi Biotech \/ Not Applicable","highestDevelopmentStatusID":"5","companyTruncated":"Zhiyi Biotech \/ Not Applicable"},{"orgOrder":0,"company":"9 Meters Biopharma","sponsor":"Gustave Roussy","pharmaFlowCategory":"D","therapeuticArea":"Gastroenterology","country":"","productType":"Small molecule","year":"2022","type":"Collaboration","leadProduct":"NM-102","moa":"Intestinal microbiome","graph1":"Gastroenterology","graph2":"IND Enabling","graph3":"9 Meters Biopharma","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Gastroenterology","amount2New":0,"dosageForm":"","sponsorNew":"9 Meters Biopharma \/ Gustave Roussy","highestDevelopmentStatusID":"5","companyTruncated":"9 Meters Biopharma \/ Gustave Roussy"},{"orgOrder":0,"company":"Asieris Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Gastroenterology","country":"","productType":"Small molecule","year":"2022","type":"Not Applicable","leadProduct":"APL-1401","moa":"","graph1":"Gastroenterology","graph2":"IND Enabling","graph3":"Asieris Pharmaceuticals","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Gastroenterology","amount2New":0,"dosageForm":"","sponsorNew":"Asieris Pharmaceuticals \/ Not Applicable","highestDevelopmentStatusID":"5","companyTruncated":"Asieris Pharmaceuticals \/ Not Applicable"},{"orgOrder":0,"company":"Renexxion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Gastroenterology","country":"","productType":"Small molecule","year":"2023","type":"Not Applicable","leadProduct":"Naronapride","moa":"","graph1":"Gastroenterology","graph2":"IND Enabling","graph3":"Renexxion","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Gastroenterology","amount2New":0,"dosageForm":"","sponsorNew":"Renexxion \/ Not Applicable","highestDevelopmentStatusID":"5","companyTruncated":"Renexxion \/ Not Applicable"},{"orgOrder":0,"company":"Naval Medical Research Center","sponsor":"Immuron","pharmaFlowCategory":"DU","therapeuticArea":"Gastroenterology","country":"U.S.A","productType":"Small molecule","year":"2023","type":"Not Applicable","leadProduct":"CampETEC","moa":"","graph1":"Gastroenterology","graph2":"IND Enabling","graph3":"Naval Medical Research Center","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Gastroenterology","amount2New":0,"dosageForm":"","sponsorNew":"Naval Medical Research Center \/ Immuron","highestDevelopmentStatusID":"5","companyTruncated":"Naval Medical Research Center \/ Immuron"},{"orgOrder":0,"company":"OnQuality Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Gastroenterology","country":"","productType":"Small molecule","year":"2023","type":"Not Applicable","leadProduct":"OQL051","moa":"","graph1":"Gastroenterology","graph2":"IND Enabling","graph3":"OnQuality Pharma","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Gastroenterology","amount2New":0,"dosageForm":"","sponsorNew":"OnQuality Pharma \/ Not Applicable","highestDevelopmentStatusID":"5","companyTruncated":"OnQuality Pharma \/ Not Applicable"},{"orgOrder":0,"company":"Asieris Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Gastroenterology","country":"","productType":"Small molecule","year":"2023","type":"Not Applicable","leadProduct":"APL-1401","moa":"","graph1":"Gastroenterology","graph2":"IND Enabling","graph3":"Asieris Pharmaceuticals","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Gastroenterology","amount2New":0,"dosageForm":"","sponsorNew":"Asieris Pharmaceuticals \/ Not Applicable","highestDevelopmentStatusID":"5","companyTruncated":"Asieris Pharmaceuticals \/ Not Applicable"},{"orgOrder":0,"company":"Giiant pharma","sponsor":"Palisade Bio","pharmaFlowCategory":"D","therapeuticArea":"Gastroenterology","country":"","productType":"Small molecule","year":"2023","type":"Licensing Agreement","leadProduct":"GT-2108","moa":"","graph1":"Gastroenterology","graph2":"IND Enabling","graph3":"Giiant pharma","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Gastroenterology","amount2New":0,"dosageForm":"","sponsorNew":"Giiant pharma \/ Palisade Bio","highestDevelopmentStatusID":"5","companyTruncated":"Giiant pharma \/ Palisade Bio"},{"orgOrder":0,"company":"Palisade Bio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Gastroenterology","country":"","productType":"Large molecule","year":"2024","type":"Not Applicable","leadProduct":"PALI-2108","moa":"","graph1":"Gastroenterology","graph2":"IND Enabling","graph3":"Palisade Bio","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Gastroenterology","amount2New":0,"dosageForm":"","sponsorNew":"Palisade Bio \/ Not Applicable","highestDevelopmentStatusID":"5","companyTruncated":"Palisade Bio \/ Not Applicable"},{"orgOrder":0,"company":"Palisade Bio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Gastroenterology","country":"","productType":"Small molecule","year":"2024","type":"Not Applicable","leadProduct":"PALI-2108","moa":"","graph1":"Gastroenterology","graph2":"IND Enabling","graph3":"Palisade Bio","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Gastroenterology","amount2New":0,"dosageForm":"","sponsorNew":"Palisade Bio \/ Not Applicable","highestDevelopmentStatusID":"5","companyTruncated":"Palisade Bio \/ Not Applicable"},{"orgOrder":0,"company":"Palisade Bio","sponsor":"Strand Life Sciences","pharmaFlowCategory":"D","therapeuticArea":"Gastroenterology","country":"","productType":"Small molecule","year":"2024","type":"Collaboration","leadProduct":"PALI-2108","moa":"","graph1":"Gastroenterology","graph2":"IND Enabling","graph3":"Palisade Bio","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Gastroenterology","amount2New":0,"dosageForm":"","sponsorNew":"Palisade Bio \/ Strand Life Sciences","highestDevelopmentStatusID":"5","companyTruncated":"Palisade Bio \/ Strand Life Sciences"},{"orgOrder":0,"company":"Palisade Bio","sponsor":"Ladenburg Thalmann","pharmaFlowCategory":"D","therapeuticArea":"Gastroenterology","country":"","productType":"Small molecule","year":"2024","type":"Public Offering","leadProduct":"PALI-2108","moa":"","graph1":"Gastroenterology","graph2":"IND Enabling","graph3":"Palisade Bio","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Gastroenterology","amount2New":0,"dosageForm":"","sponsorNew":"Palisade Bio \/ Ladenburg Thalmann","highestDevelopmentStatusID":"5","companyTruncated":"Palisade Bio \/ Ladenburg Thalmann"}]

Find FDA Investigational New Drug (IND) Submissions for Gastroenterology

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                          01

                          Medlab Asia & Asia Health
                          Not Confirmed
                          Medlab Asia & Asia Health
                          Not Confirmed

                          Details : PALI-2108 is an orally administered, locally acting colon-specific phosphodiesterase-4 (PDE4) inhibitor prodrug. It is being evaluated for the treatment of ulcerative colitis.

                          Brand Name : PALI-2108

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          October 10, 2024

                          Lead Product(s) : PALI-2108

                          Therapeutic Area : Gastroenterology

                          Highest Development Status : IND Enabling

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          02

                          Medlab Asia & Asia Health
                          Not Confirmed
                          Medlab Asia & Asia Health
                          Not Confirmed

                          Details : SL-325 is a first-in-class antagonist antibody to DR3, the receptor for TL1A, which is being evaluated for the treatment of inflammatory bowel disease.

                          Brand Name : SL-325

                          Molecule Type : Large molecule

                          Upfront Cash : Not Applicable

                          October 01, 2024

                          Lead Product(s) : SL-325

                          Therapeutic Area : Gastroenterology

                          Highest Development Status : IND Enabling

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          03

                          Medlab Asia & Asia Health
                          Not Confirmed
                          Medlab Asia & Asia Health
                          Not Confirmed

                          Details : PALI-2108 is an orally administered, locally acting colon-specific phosphodiesterase-4 (PDE4) inhibitor prodrug. It is being evaluated for the treatment of ulcerative colitis.

                          Brand Name : PALI-2108

                          Molecule Type : Large molecule

                          Upfront Cash : Not Applicable

                          September 05, 2024

                          Lead Product(s) : PALI-2108

                          Therapeutic Area : Gastroenterology

                          Highest Development Status : IND Enabling

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          04

                          Medlab Asia & Asia Health
                          Not Confirmed
                          Medlab Asia & Asia Health
                          Not Confirmed

                          Details : TRX103, a first-in-class Type 1 Treg cell therapy candidate, which is being evaluated for the treatment of patients with treatment-refractory crohn’s disease.

                          Brand Name : TRX103

                          Molecule Type : Cell and Gene therapy

                          Upfront Cash : Not Applicable

                          August 07, 2024

                          Lead Product(s) : TRX103

                          Therapeutic Area : Gastroenterology

                          Highest Development Status : IND Enabling

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          05

                          Medlab Asia & Asia Health
                          Not Confirmed
                          Medlab Asia & Asia Health
                          Not Confirmed

                          Details : PALI-2108 is an orally administered, locally acting colon-specific phosphodiesterase-4 (PDE4) inhibitor prodrug. It is being evaluated for the treatment of ulcerative colitis.

                          Brand Name : PALI-2108

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          April 16, 2024

                          Lead Product(s) : PALI-2108

                          Therapeutic Area : Gastroenterology

                          Highest Development Status : IND Enabling

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          06

                          Medlab Asia & Asia Health
                          Not Confirmed
                          Medlab Asia & Asia Health
                          Not Confirmed

                          Details : BT-600 (tofacitinib) is a drug/device combination designed to use Biora’s NaviCap™ ingestible drug delivery device with a proprietary liquid formulation of tofacitinib. It is being evaluated for the treatment of Ulcerative Colitis.

                          Brand Name : BT-600

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          November 29, 2023

                          Lead Product(s) : Tofacitinib Citrate

                          Therapeutic Area : Gastroenterology

                          Highest Development Status : IND Enabling

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          07

                          Medlab Asia & Asia Health
                          Not Confirmed