MedPath

Dabigatran

Generic Name
Dabigatran
Brand Names
Dabigatran Etexilate Leon Farma, Dabigatran Etexilate Accord, Pradaxa
Drug Type
Small Molecule
Chemical Formula
C25H25N7O3
CAS Number
211914-51-1
Unique Ingredient Identifier
I0VM4M70GC

Overview

Dabigatran is the active form of the orally bioavailable prodrug dabigatran etexilate.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/04/25
Phase 1
Recruiting
2025/02/10
Phase 2
Not yet recruiting
2024/10/21
Phase 4
Not yet recruiting
Emily McDonald
2024/08/13
Phase 3
Recruiting
2024/08/13
Phase 3
Recruiting
2024/06/10
Not Applicable
Active, not recruiting
2024/06/04
Phase 1
Not yet recruiting
International Bio service
2024/04/29
N/A
Not yet recruiting
The Affiliated Hospital Of Guizhou Medical University
2023/05/01
N/A
Completed
2023/03/28
Phase 1
Terminated

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Aurobindo Pharma Limited
59651-973
ORAL
75 mg in 1 1
5/15/2025
Bryant Ranch Prepack
63629-8242
ORAL
150 mg in 1 1
6/25/2021
Boehringer Ingelheim Pharmaceuticals, Inc.
0597-0450
ORAL
150 mg in 1 1
11/27/2023
Boehringer Ingelheim Pharmaceuticals Inc.
0597-0108
ORAL
110 mg in 1 1
11/28/2023
Camber Pharmaceuticals, Inc.
31722-622
ORAL
150 mg in 1 1
7/8/2023
Aurobindo Pharma Limited
59651-974
ORAL
110 mg in 1 1
5/15/2025
A-S Medication Solutions
50090-3617
ORAL
150 mg in 1 1
4/23/2021
Camber Pharmaceuticals, Inc.
31722-621
ORAL
75 mg in 1 1
7/8/2023
American Health Packaging
60687-744
ORAL
75 mg in 1 1
3/30/2023
XLCare Pharmaceuticals, Inc.
72865-273
ORAL
150 mg in 1 1
7/26/2023

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Help Us Improve

Your feedback helps us provide better drug information and insights.

© Copyright 2025. All Rights Reserved by MedPath