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    [{"orgOrder":0,"company":"IntraBio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"UNITED KINGDOM","productType":"Small molecule","year":"2020","type":"Not Applicable","leadProduct":"N-Acetyl-L-Leucine","moa":"","graph1":"Rare Diseases and Disorders","graph2":"Phase III","graph3":"IntraBio","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Rare Diseases","amount2New":0,"dosageForm":"Oral","sponsorNew":"IntraBio \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"IntraBio \/ Not Applicable"},{"orgOrder":0,"company":"IntraBio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"","productType":"Small molecule","year":"2020","type":"Not Applicable","leadProduct":"N-Acetyl-L-Leucine","moa":"","graph1":"Genetic Disease","graph2":"Phase II","graph3":"IntraBio","amount2":0,"highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Oral","sponsorNew":"IntraBio \/ Not Applicable","highestDevelopmentStatusID":"8","companyTruncated":"IntraBio \/ Not Applicable"},{"orgOrder":0,"company":"IntraBio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"","productType":"Small molecule","year":"2020","type":"Not Applicable","leadProduct":"N-Acetyl-L-Leucine","moa":"","graph1":"Rare Diseases and Disorders","graph2":"Phase III","graph3":"IntraBio","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Rare Diseases","amount2New":0,"dosageForm":"Oral","sponsorNew":"IntraBio \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"IntraBio \/ Not Applicable"},{"orgOrder":0,"company":"IntraBio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Rare Diseases and Disorders","country":"","productType":"Small molecule","year":"2022","type":"Not Applicable","leadProduct":"N-Acetyl-L-Leucine","moa":"","graph1":"Rare Diseases and Disorders","graph2":"Phase III","graph3":"IntraBio","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Rare Diseases","amount2New":0,"dosageForm":"Granules for Oral Suspension","sponsorNew":"IntraBio \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"IntraBio \/ Not Applicable"},{"orgOrder":0,"company":"IntraBio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Rare Diseases and Disorders","country":"","productType":"Small molecule","year":"2022","type":"Not Applicable","leadProduct":"N-Acetyl-L-Leucine","moa":"","graph1":"Rare Diseases and Disorders","graph2":"Phase III","graph3":"IntraBio","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Rare Diseases","amount2New":0,"dosageForm":"Granules for Oral Suspension","sponsorNew":"IntraBio \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"IntraBio \/ Not Applicable"},{"orgOrder":0,"company":"IntraBio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Rare Diseases and Disorders","country":"","productType":"Small molecule","year":"2023","type":"Not Applicable","leadProduct":"N-Acetyl-L-Leucine","moa":"","graph1":"Rare Diseases and Disorders","graph2":"Phase III","graph3":"IntraBio","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Rare Diseases","amount2New":0,"dosageForm":"Granules for Oral Suspension","sponsorNew":"IntraBio \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"IntraBio \/ Not Applicable"},{"orgOrder":0,"company":"IntraBio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Rare Diseases and Disorders","country":"","productType":"Small molecule","year":"2024","type":"Not Applicable","leadProduct":"N-Acetyl-L-Leucine","moa":"","graph1":"Rare Diseases and Disorders","graph2":"Phase III","graph3":"IntraBio","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Rare Diseases","amount2New":0,"dosageForm":"Granules for Oral Suspension","sponsorNew":"IntraBio \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"IntraBio \/ Not Applicable"},{"orgOrder":0,"company":"IntraBio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Rare Diseases and Disorders","country":"","productType":"Small molecule","year":"2024","type":"Not Applicable","leadProduct":"Levacetylleucine","moa":"","graph1":null,"graph2":null,"graph3":"IntraBio","amount2":0,"highestDevelopmentShortName":null,"therapeuticAreaShortName":null,"amount2New":0,"dosageForm":"","sponsorNew":"IntraBio \/ Not Applicable","highestDevelopmentStatusID":null,"companyTruncated":"IntraBio \/ Not Applicable"}]

    Find Clinical Drug Pipeline Developments & Deals by IntraBio

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                            01

                            IntraBio

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                            2024 ACI Convention
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                            Lead Product(s) : Levacetylleucine

                            Therapeutic Area : Rare Diseases and Disorders

                            Study Phase : Approved

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            US FDA Approves IntraBio's Drug for Rare Genetic Disease

                            Details : Aqneursa (levacetylleucine) is a calcium channel modulator. It is approved and indicated for the treatment of Type C Niemann-Pick Disease in pediatrics and adults.

                            Brand Name : Aqneursa

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            September 25, 2024

                            Lead Product(s) : Levacetylleucine

                            Therapeutic Area : Rare Diseases and Disorders

                            Highest Development Status : Approved

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            02

                            IntraBio

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                            2024 ACI Convention
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                            Lead Product(s) : N-Acetyl-L-Leucine

                            Therapeutic Area : Rare Diseases and Disorders

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            IntraBio’s New Drug Application for IB1001 in Niemann-Pick Disease Type C Accepted by FDA

                            Details : IB1001 (N-Acetyl-L-Leucine) is a calcium channel modulator. It is being evaluated in the phase III clinical trial studies for the treatment of Type C Niemann-Pick Disease.

                            Brand Name : IB1001

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            March 26, 2024

                            Lead Product(s) : N-Acetyl-L-Leucine

                            Therapeutic Area : Rare Diseases and Disorders

                            Highest Development Status : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            03

                            IntraBio

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                            Lead Product(s) : N-Acetyl-L-Leucine

                            Therapeutic Area : Rare Diseases and Disorders

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            IntraBio NPC Phase III Successful Trial

                            Details : IB1001 (n-acetyl-l-leucine) is a novel, orally administered therapy with a unique mechanism of action offering neuroprotective and symptomatic benefits for rare and common neurological disorders. it's being developed for NPC, GM1 and GM2 gangliosides, an...

                            Brand Name : IB1001

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            June 29, 2023

                            Lead Product(s) : N-Acetyl-L-Leucine

                            Therapeutic Area : Rare Diseases and Disorders

                            Highest Development Status : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            04

                            IntraBio

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                            Lead Product(s) : N-Acetyl-L-Leucine

                            Therapeutic Area : Rare Diseases and Disorders

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            IntraBio Completes Recruitment for IB1001 NPC Pivotal Clinical Trial

                            Details : IB1001-301 investigates N-Acetyl-L-Leucine (IB1001) for both the symptomatic and long-term neuroprotective effect of treatment of Niemann-Pick disease Type C (NPC), with the primary endpoint based on the Scale for the Assessment and Rating of Ataxia.

                            Brand Name : IB1001

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            December 08, 2022

                            Lead Product(s) : N-Acetyl-L-Leucine

                            Therapeutic Area : Rare Diseases and Disorders

                            Highest Development Status : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            05

                            IntraBio

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                            Lead Product(s) : N-Acetyl-L-Leucine

                            Therapeutic Area : Rare Diseases and Disorders

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            IntraBio Reaches Target Enrollment for IB1001 NPC Pivotal Clinical Trial

                            Details : IB1001-301 investigates IB100 (N-acetyl-L-leucine) for both the symptomatic and long-term neuroprotective effect of treatment of Niemann-Pick disease Type C (NPC), with the primary endpoint based on the Scale for the Assessment and Rating of Ataxia.

                            Brand Name : IB1001

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            November 22, 2022

                            Lead Product(s) : N-Acetyl-L-Leucine

                            Therapeutic Area : Rare Diseases and Disorders

                            Highest Development Status : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            06

                            IntraBio

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                            Lead Product(s) : N-Acetyl-L-Leucine

                            Therapeutic Area : Genetic Disease

                            Study Phase : Phase II

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            IntraBio Reports Further Detail on Positive Data from IB1001 Multinational Clinical Trial for the Treatment of...

                            Details : IB1001 demonstrated a statistically significant and clinically meaningful change in both the primary and secondary endpoints.

                            Brand Name : IB1001

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            October 19, 2020

                            Lead Product(s) : N-Acetyl-L-Leucine

                            Therapeutic Area : Genetic Disease

                            Highest Development Status : Phase II

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            07

                            IntraBio

                            United Kingdom arrow
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                            Lead Product(s) : N-Acetyl-L-Leucine

                            Therapeutic Area : Genetic Disease

                            Study Phase : Phase II

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            IntraBio Reports Positive Data from IB1001 Multinational Clinical Trial for the Treatment of Niemann-Pick dise...

                            Details : IB1001 demonstrated a statistically significant and clinically meaningful improvement in symptoms, functioning, and quality of life in both primary and topline secondary endpoints for both pediatric and adult patients with NPC.

                            Brand Name : IB1001

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            September 30, 2020

                            Lead Product(s) : N-Acetyl-L-Leucine

                            Therapeutic Area : Genetic Disease

                            Highest Development Status : Phase II

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            08

                            IntraBio

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                            Lead Product(s) : N-Acetyl-L-Leucine

                            Therapeutic Area : Genetic Disease

                            Study Phase : Phase II

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            IntraBio Receives FDA Fast Track Designation for Niemann-Pick Disease

                            Details : IB1001 (N-acetyl-L-leucine) is currently being investigated for the symptomatic, and disease-modifying, neuroprotective treatment of NPC in a multinational clinical trial (IB1001-201).

                            Brand Name : Undisclosed

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            March 25, 2020

                            Lead Product(s) : N-Acetyl-L-Leucine

                            Therapeutic Area : Genetic Disease

                            Highest Development Status : Phase II

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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