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Mycophenolic acid

Generic Name
Mycophenolic acid
Brand Names
Myfortic
Drug Type
Small Molecule
Chemical Formula
C17H20O6
CAS Number
24280-93-1
Unique Ingredient Identifier
HU9DX48N0T

Overview

Mycophenolic acid is a potent immunosuppressant agent that inhibits de novo purine biosynthesis. It was derived from Penicillium stoloniferum, and has also shown antibacterial, antifungal and antiviral properties.. Mycophenolic acid is used in immunosuppressive regimens as part of a triple therapy that includes a calcineurin inhibitor (ciclosporin or tacrolimus) and prednisolone. This regimen can be used in place of the older anti-proliferative azathioprine due to its stronger immunosuppressive potency. However, mycophenolic acid treatment is more expensive and requires therapeutic drug monitoring to optimize efficacy and minimize toxicity. Mycophenolic acid is available as enteric-coated tablets of delayed-release, in an effort to improve upper gastrointestinal adverse events by delaying mycophenolic acid release until it reaches the small intestine. Mycophenolate mofetil, a prodrug of mycophenolic acid, is also prescribed to transplant recipients to prevent organ rejection.

Background

Mycophenolic acid is a potent immunosuppressant agent that inhibits de novo purine biosynthesis. It was derived from Penicillium stoloniferum, and has also shown antibacterial, antifungal and antiviral properties.. Mycophenolic acid is used in immunosuppressive regimens as part of a triple therapy that includes a calcineurin inhibitor (ciclosporin or tacrolimus) and prednisolone. This regimen can be used in place of the older anti-proliferative azathioprine due to its stronger immunosuppressive potency. However, mycophenolic acid treatment is more expensive and requires therapeutic drug monitoring to optimize efficacy and minimize toxicity. Mycophenolic acid is available as enteric-coated tablets of delayed-release, in an effort to improve upper gastrointestinal adverse events by delaying mycophenolic acid release until it reaches the small intestine. Mycophenolate mofetil, a prodrug of mycophenolic acid, is also prescribed to transplant recipients to prevent organ rejection.

Indication

Mycophenolic acid is an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. Mycophenolic acid is used in combination with cyclosporine and corticosteroids.

Associated Conditions

  • Kidney Transplant Rejection

Clinical Trials

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Title
Posted
Study ID
Phase
Status
Sponsor
2024/03/01
Phase 3
Completed
National Institute of Blood and Marrow Transplant (NIBMT), Pakistan
2023/10/05
Phase 2
Recruiting
2023/09/21
Phase 4
Recruiting
2023/05/24
Phase 4
Not yet recruiting
Zhishui Chen
2023/02/01
N/A
Recruiting
Third Affiliated Hospital, Sun Yat-Sen University
2022/11/23
Phase 4
Recruiting
Post Graduate Institute of Medical Education and Research, Chandigarh
2022/10/06
Phase 2
Recruiting
LMU Klinikum
2022/06/29
Phase 1
Recruiting
2022/04/01
Phase 2
Terminated
2022/03/31
Phase 4
UNKNOWN

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Major Pharmaceuticals
0904-6785
ORAL
180 mg in 1 1
6/3/2022
Accord Healthcare Inc.
16729-261
ORAL
180 mg in 1 1
1/17/2024
Ascend Laboratories, LLC
67877-427
ORAL
360 mg in 1 1
6/20/2022
Advagen Pharma Limited
72888-199
ORAL
180 mg in 1 1
3/7/2024
Archis Pharma LLC
72819-156
ORAL
360 mg in 1 1
9/21/2023
Novartis Pharmaceuticals Corporation
0078-0385
ORAL
180 mg in 1 1
4/19/2016
Aurobindo Pharma Limited
59651-622
ORAL
360 mg in 1 1
3/4/2024
Major Pharmaceuticals
0904-7457
ORAL
360 mg in 1 1
1/3/2024
Biocon Pharma Inc.
70377-040
ORAL
360 mg in 1 1
6/17/2022
Accord Healthcare Inc.
16729-189
ORAL
360 mg in 1 1
1/17/2024

EMA Drug Approvals

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Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Approval Number
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Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Mycophenolate Sodium Enteric-coated Tablets
国药准字HJ20240083
化学药品
片剂
8/20/2024
Mycophenolate Sodium Enteric-coated Tablets
国药准字H20243021
化学药品
片剂
1/9/2024
Mycophenolate Sodium Enteric-coated Tablets
国药准字HJ20240003
化学药品
片剂
1/9/2024
Mycophenolate Sodium Enteric-coated Tablets
国药准字H20213232
化学药品
片剂
3/30/2021
Mycophenolate Sodium Enteric-coated Tablets
国药准字H20243022
化学药品
片剂
1/9/2024
Mycophenolate Sodium Enteric-coated Tablets
国药准字H20244471
化学药品
片剂
7/22/2024
Mycophenolate Sodium Enteric-coated Tablets
国药准字H20244004
化学药品
片剂
6/11/2024
Mycophenolate Sodium Enteric-coated Tablets
国药准字HJ20160051
化学药品
片剂
5/5/2023

PPB Drug Approvals

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Company
Licence No.
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No PPB approvals found for this drug.
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