MedPath

Beraprost

Generic Name
Beraprost
Drug Type
Small Molecule
Chemical Formula
C24H30O5
CAS Number
88430-50-6
Unique Ingredient Identifier
35E3NJJ4O6

Overview

Beraprost is a synthetic analogue of prostacyclin, under clinical trials for the treatment of pulmonary hypertension. It is also being studied for use in avoiding reperfusion injury.

Indication

For the treatment of pulmonary hypertension.

Associated Conditions

  • Cystic Fibrosis (CF)
  • Pain
  • Ulcers
  • Sensations of cold

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2021/11/02
Early Phase 1
UNKNOWN
Shenzhen People's Hospital
2018/09/25
Phase 4
UNKNOWN
2018/02/13
Phase 4
Completed
Dr. Soetomo General Hospital
2017/05/05
Not Applicable
UNKNOWN
2016/06/01
Phase 4
Terminated
2015/06/24
Phase 2
Completed
2013/07/26
Phase 3
Completed
2013/02/21
Not Applicable
UNKNOWN
2011/10/24
Phase 3
Withdrawn
2011/09/29
Phase 1
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

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
Beraprost Sodium Tablets
国药准字H20253082
化学药品
片剂
1/8/2025
Beraprost Sodium Tablets
国药准字H20253372
化学药品
片剂
2/11/2025
Beraprost Sodium Tablets
国药准字H20234630
化学药品
片剂
12/13/2023
Beraprost Sodium Tablets
国药准字H20243966
化学药品
片剂
6/11/2024
Beraprost Sodium Tablets
国药准字H20243696
化学药品
片剂
5/15/2024
Beraprost Sodium Tablets
国药准字H20249757
化学药品
片剂
12/17/2024
Beraprost Sodium Tablets
国药准字HJ20181057
化学药品
片剂
11/4/2022
Beraprost Sodium Tablets
国药准字H20083589
化学药品
片剂(薄膜衣片)
11/11/2022
Beraprost Sodium Tablets
国药准字H20083588
化学药品
片剂(薄膜衣片)
11/11/2022
Beraprost Sodium Tablets
国药准字H20244522
化学药品
片剂
7/30/2024

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.

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