Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : N-Acetyl-L-Leucine
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
A Pivotal Study of N-Acetyl-L-Leucine on Ataxia-Telangiectasia (A-T)
Details : N-Acetyl-L-Leucine is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Ataxia Telangiectasia.
Product Name : Undisclosed
Product Type : Amino Acid
Upfront Cash : Inapplicable
November 04, 2024
Lead Product(s) : N-Acetyl-L-Leucine
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Levacetylleucine
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Approved FDF
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Aqneursa
Product Type : Amino Acid
Upfront Cash : Inapplicable
September 25, 2024
Lead Product(s) : Levacetylleucine
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : N-Acetyl-L-Leucine
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Undisclosed
Product Type : Amino Acid
Upfront Cash : Inapplicable
March 26, 2024
Lead Product(s) : N-Acetyl-L-Leucine
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : N-Acetyl-L-Leucine
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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...
Product Name : Undisclosed
Product Type : Amino Acid
Upfront Cash : Inapplicable
June 29, 2023
Lead Product(s) : N-Acetyl-L-Leucine
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : N-Acetyl-L-Leucine
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Undisclosed
Product Type : Amino Acid
Upfront Cash : Inapplicable
December 08, 2022
Lead Product(s) : N-Acetyl-L-Leucine
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : N-Acetyl-L-Leucine
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Undisclosed
Product Type : Amino Acid
Upfront Cash : Inapplicable
November 22, 2022
Lead Product(s) : N-Acetyl-L-Leucine
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : N-Acetyl-L-Leucine
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
A Pivotal Study of N-Acetyl-L-Leucine on Niemann-Pick Disease Type C
Details : N-Acetyl-L-Leucine is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Niemann-Pick Disease, Type C.
Product Name : Undisclosed
Product Type : Amino Acid
Upfront Cash : Inapplicable
December 20, 2021
Lead Product(s) : N-Acetyl-L-Leucine
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : N-Acetyl-L-Leucine
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Phase II
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : IB1001 demonstrated a statistically significant and clinically meaningful change in both the primary and secondary endpoints.
Product Name : Undisclosed
Product Type : Amino Acid
Upfront Cash : Inapplicable
October 19, 2020
Lead Product(s) : N-Acetyl-L-Leucine
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase II
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : N-Acetyl-L-Leucine
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Phase II
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Undisclosed
Product Type : Amino Acid
Upfront Cash : Inapplicable
September 30, 2020
Lead Product(s) : N-Acetyl-L-Leucine
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase II
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : N-Acetyl-L-Leucine
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Phase II
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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).
Product Name : Undisclosed
Product Type : Amino Acid
Upfront Cash : Inapplicable
March 25, 2020
Lead Product(s) : N-Acetyl-L-Leucine
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase II
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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