CDEK
← All drugs Report issue

n-acetylleucine

Trade name: Tanganil

Small moleculeapprovedOrphan Drug FDAFast Track FDA

Approved

Sep 24, 2024

Clinical trial activity

7 trials · 2 clinical orgs · 1 marketing orgs

Phase 1
0
Phase 2
7
Phase 3
4
Phase 4
0

Earliest trial started Jun 1, 2019 (NCT03759665)

Timeline

2010s

  1. Jan 1, 2019

    IntraBio Inc — Earliest Phase 2 Sponsor(trial)

2020s

  1. Sep 8, 2021

    Orphan Drug Designation

  2. Jan 1, 2022

    IntraBio Inc — Earliest Phase 3 Sponsor(trial)

  3. Sep 24, 2024

    IntraBio Inc — Earliest FDA Approval

  4. Sep 24, 2024

    IntraBio Inc — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

  • Unspecified targetOTHER

    Unknown

  • Unspecified targetUnclear

    unclear

Approval history

  • approvedPriority reviewFast trackSep 24, 2024

Chemistry & pharmacology

Loading structure…

SMILES

CC(=O)NC(CC(C)C)C(=O)O
Mol. weight
173.21 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • acetylleucine
  • acetylleucine
  • acetylleucine
  • acetylleucine
  • acetylleucine
  • acetyl-l-leucine
  • n-acetylleucine
  • (s)-2-acetamido-4-methylpentanoic acid

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07221292Phase 3Sep 1, 2026IntraBio Inc
NCT07275749Phase 3Dec 1, 2025Kafrelsheikh University
NCT06673056Phase 3Mar 1, 2025IntraBio Inc
NCT05163288Phase 3Feb 28, 2022IntraBio Inc
NCT03759639Phase 2Jun 1, 2019IntraBio Inc
NCT03759678Phase 2Jun 1, 2019IntraBio Inc
NCT03759665Phase 2Jun 1, 2019IntraBio Inc
Showing 7 of 7 trials
Page 1 / 1

Organizations

Research & Development (2)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
IntraBio IncFor profit6622019
Kafrelsheikh UniversityAcademic/Hospital1112025
2 organizations
Page 1 / 1

Marketing (1)

OrganizationOrg typeRelationshipDate
IntraBio IncFor profitNDASep 24, 2024