CLINICAL TRIALS PROFILE FOR MYCOPHENOLIC ACID

All Clinical Trials for Mycophenolic Acid

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00128947 ↗	Pharmacokinetics of Mycophenolate Mofetil in Healthy Volunteers	Completed	National Institutes of Health Clinical Center (CC)	Phase 1	2005-07-01	This study will examine how people differ in the way their bodies process and eliminate mycophenolate mofetil (MMF), a drug that is used to treat problems affecting the eye and immune system and to prevent organ rejection in transplant patients. MMF is metabolized by a group of enzymes called UGTs, each of which is made by a different gene. This study will investigate whether people with different UGT genes differ in how well their bodies use and remove MMF. The results may help scientists learn the best way to give MMF to patients. Normal healthy volunteers between 18 and 55 years of age may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood and urine tests, including a blood test for analysis of genes that control and regulate UGTs. Pregnant women and nursing mothers are excluded from the study. Women who are able to have a child and men who can father a child must either abstain from sex or use two reliable forms of birth control during the study and for 3 months after its completion. Participants come to the NIH Clinical Center at 6:30 a.m. on the first day of the study and stay in the outpatient clinic for 12 hours. The next 4 mornings, they return to the Clinical Center for a single blood collection. The procedures for the 5 days are as follows: Day 1 Upon arrival at the Clinical Center a catheter is inserted into the subject's arm vein. At 7:00 AM, the subject takes one dose of MMF by mouth with a glass of water. Small blood samples are collected through the catheter before the MMF dose and again at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours after taking the drug. Heart rate and blood pressure are measured before the blood collection and then every 4 hours. After the last blood sample is collected, the volunteer can return home. Days 2-5 Volunteers come to the Clinical Center at 7:00 AM on study days 2, 3, 4, and 5 for a single blood draw, collected using a needle. Volunteers are contacted by telephone 1, 2, and 3 months after completing the study to see how they are doing and to check on their pregnancy status and use of appropriate birth control.
NCT00166244 ↗	Fixed Dose MMF vs Concentration Controlled MMF After Renal Transplantation	Completed	Hoffmann-La Roche	Phase 4	2003-05-01	Determine the value of a clinically feasible strategy of therapeutic drug monitoring compared with fixed dosing in de novo MMF treated renal transplant recipients with respect to the incidence of treatment failure.
NCT00166153 ↗	Outcomes in Pediatric Heart Transplant Recipients Receiving Cellcept	Terminated	Emory University	N/A	2003-01-01	The survival of children who have received heart transplants has greatly improved over the last ten years. One reason for this is better control over rejection. Rejection medications require a delicate balance of enough medicine to work without causing side effects. It is a goal to avoid both rejection and side effects from the anti-rejection medicines. Usually several medicines are used together to prevent rejection. One of these medicines is often Mycophenolic Acid or CellceptThis medicine has been used longer for adults than is has for children. More information is needed on using it for children. The dose is usually determined by the patient's weight or body surface area. There have been some early studies of the use of Cellcept, but none have proven a relationship between the blood level of the drug and how well it works. More also needs to be known about how this drug works with other anti-rejection drugs and how it works in boys and girls. This study will look more closely at proper dosing, how Cellcept works with other anti-rejection medications, side effects, and any differences in how this medicine works in boys and girls. All patients in the study will be receiving Cellcept and have blood levels of the drug drawn. Results of their usual treatment and testing will be recorded and evaluated for signs of rejection. All the information will be analyzed. Results of this study will be reported to transplant committees locally and nationally.
NCT00007059 ↗	Study of the Pharmacokinetics of Mycophenolate Mofetil in Patients Who Have Undergone Orthotopic Liver Transplantation	Completed	University of North Carolina	N/A	1998-06-01	OBJECTIVES: I. Determine the effects of bile externalization and antibiotic gut sterilization on the pharmacokinetics of mycophenolate mofetil in patients who have undergone orthotopic liver transplantation. II. Correlate serum concentrations of mycophenolic acid with inosine monophosphate dehydrogenase activity in these patients.
NCT00007059 ↗	Study of the Pharmacokinetics of Mycophenolate Mofetil in Patients Who Have Undergone Orthotopic Liver Transplantation	Completed	National Center for Research Resources (NCRR)	N/A	1998-06-01	OBJECTIVES: I. Determine the effects of bile externalization and antibiotic gut sterilization on the pharmacokinetics of mycophenolate mofetil in patients who have undergone orthotopic liver transplantation. II. Correlate serum concentrations of mycophenolic acid with inosine monophosphate dehydrogenase activity in these patients.
NCT00021489 ↗	Mycophenolate Mofetil and Abacavir Treatment in HIV Patients With Failed Anti-HIV Treatment	Withdrawn	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	The purpose of this study is to learn how safe and well-tolerated mycophenolate mofetil (MMF) is when given with abacavir (ABC). Another purpose is to see if adding MMF to ABC decreases viral load (amount of HIV in the blood) more than ABC alone. Many HIV-infected patients who have had heavy exposure to anti-HIV drugs and have experienced treatment failure need new treatment combinations. One promising combination is ABC and MMF as part of a drug combination. Laboratory studies show that MMF helps ABC destroy HIV in the cells and further clinical testing is needed. MMF is not FDA-approved as a treatment for HIV infection but has been approved by FDA to prevent rejection of organ transplants. Doses of MMF tested in this study will be lower than those used to treat people with organ transplants.

Clinical Trial Conditions for Mycophenolic Acid

Condition Name

Condition Name for Mycophenolic Acid
Intervention	Trials
Kidney Transplantation	20
Lupus Nephritis	7
Renal Transplantation	7
Liver Transplantation	6

Condition MeSH

Condition MeSH for Mycophenolic Acid
Intervention	Trials
Renal Insufficiency	9
Nephritis	8
Kidney Failure, Chronic	7
Lupus Nephritis	7

Clinical Trial Locations for Mycophenolic Acid

Trials by Country

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Trials by Country for Mycophenolic Acid
Location	Trials
United States	188
Canada	25
Spain	21
Germany	15
France	14

Trials by US State

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Trials by US State for Mycophenolic Acid
Location	Trials
California	19
New York	12
Ohio	11
Pennsylvania	10
Florida	10

Clinical Trial Progress for Mycophenolic Acid

Clinical Trial Phase

Clinical Trial Phase for Mycophenolic Acid
Clinical Trial Phase	Trials
Phase 4	47
Phase 3	19
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for Mycophenolic Acid
Clinical Trial Phase	Trials
Completed	61
Terminated	16
Recruiting	12

Clinical Trial Sponsors for Mycophenolic Acid

Sponsor Name

Sponsor Name for Mycophenolic Acid
Sponsor	Trials
Novartis Pharmaceuticals	19
Novartis	13
Hoffmann-La Roche	12

Sponsor Type

Sponsor Type for Mycophenolic Acid
Sponsor	Trials
Other	133
Industry	62
NIH	10

Mycophenolic Acid: Clinical Trials, Market Analysis, and Projections

Introduction to Mycophenolic Acid

Mycophenolic acid (MPA) is a potent immunosuppressant drug that plays a crucial role in preventing organ rejection in transplant patients and treating various autoimmune diseases. Its market is experiencing significant growth driven by several key factors, including increasing demand for organ transplants and the rising prevalence of autoimmune diseases.

Clinical Trials and Research Usage

Ongoing and Completed Trials

Mycophenolic acid is not only used in clinical practice but also in various research applications. It is a key component in the development of new immunosuppressive medications and therapies. Clinical trials often focus on optimizing MPA treatment through therapeutic drug monitoring, which is crucial for preventing organ rejection and managing side effects[1][3].

Pharmacogenomics and Biotechnology

Advances in pharmacogenomics and biotechnology are driving tailored medical approaches that maximize therapeutic outcomes. These developments help in creating innovative formulations and enhancing drug delivery methods, which are critical for improving treatment efficacy and patient adherence[2].

Market Analysis

Market Size and Growth Projections

The global mycophenolic acid market has shown robust growth in recent years. In 2023, the market size was valued at USD 100 million and is expected to reach USD 147.7 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5% from 2024 to 2031[2].

Regional Market Dynamics

• North America: This region is expected to lead in terms of revenue growth due to the well-developed pharmaceutical industry and high healthcare spending. The North American market is anticipated to register the highest revenue CAGR[1][3].
• Europe: Europe has the second-largest market share and significant room for growth, driven by advances in bionics and biomedical equipment[1][3].
• Asia Pacific: The Asia Pacific region is anticipated to experience rapid revenue growth due to increasing urban prosperity, growing demand for modern therapies and transplants, and a larger patient pool requiring immunosuppressive therapy[1][5].

Applications and Usage

Medical Usage

Mycophenolic acid is widely used as an immunosuppressant to prevent organ rejection in transplant patients. It is also employed in treating autoimmune diseases such as psoriasis, dermatomyositis, systemic lupus erythematosus (SLE), and rheumatoid arthritis. The drug's efficacy in reducing lymphocyte proliferation makes it a critical component in immunosuppressive therapy[1][3][5].

Research Usage

In addition to its medical applications, MPA is used in various research settings, particularly in the development of new immunosuppressive medications and therapies. This dual role underscores its importance in both clinical practice and medical research[1].

Driving Factors

Increasing Demand for Organ Transplants

The rise in organ transplant procedures is a major driver of the mycophenolic acid market. As the number of surgeries increases, so does the demand for effective immunosuppressants like MPA[2][4].

Rising Prevalence of Autoimmune Diseases

The increasing prevalence of autoimmune diseases such as lupus, rheumatoid arthritis, and multiple sclerosis is driving the demand for mycophenolic acid. These diseases often require long-term immunosuppressive therapy, contributing to the market's steady expansion[2][5].

Technological Advancements

Advances in drug formulations and delivery systems are crucial for improving therapeutic efficacy and patient adherence. The approval of new formulations and indications by regulators further propels market expansion[2].

Healthcare Infrastructure and Regulations

Growing investments in healthcare infrastructure and research projects, along with favorable healthcare regulations that support organ donation and transplant programs, are also driving the market growth[2].

Key Players and Market Competition

The mycophenolic acid market is competitive, with several key players involved, including Roche Holding AG, Novartis AG, Mylan N.V., Lupin Limited, and Teva Pharmaceutical Industries Ltd. among others. These companies are focused on developing innovative formulations and enhancing drug delivery methods to improve therapeutic outcomes[2].

Market Pricing Trends

The prices of mycophenolic acid are expected to remain competitive due to the presence of multiple manufacturers and the ongoing development of generic and biosimilar versions of the drug. This competition helps in keeping the market prices stable and accessible[1].

Challenges and Limitations

High Cost and Side Effects

Despite the market growth, high costs associated with mycophenolic acid and its potential side effects, such as diarrhea, pain, vomiting, and blood infections, can impede market growth. Lack of awareness in some regions also poses a challenge[4].

Future Outlook

Emerging Markets and Opportunities

The Asia Pacific region, in particular, is expected to see rapid growth due to increasing urban prosperity and the growing need for modern therapies and transplants. Emerging markets offer substantial investment opportunities, driven by rising healthcare expenditures and improving healthcare infrastructure[1][5].

Research and Development

Continuous research and development activities, including the emergence of new markets and the development of innovative formulations, will provide beneficial opportunities for the mycophenolic acid market in the forecast period[4].

Key Takeaways

• The global mycophenolic acid market is projected to grow significantly, driven by increasing demand for organ transplants and the rising prevalence of autoimmune diseases.
• North America and Europe are key regions driving market growth, with the Asia Pacific region showing rapid expansion.
• Technological advancements in drug formulations and delivery systems are driving market innovation.
• Therapeutic drug monitoring is crucial for optimizing MPA treatment.
• The market offers substantial investment opportunities in both mature and emerging markets.

FAQs

Q: What is the primary use of mycophenolic acid?

A: Mycophenolic acid is primarily used as an immunosuppressant to prevent organ rejection in transplant patients and to treat autoimmune diseases such as psoriasis and dermatomyositis[1].

Q: Which regions are expected to lead in the mycophenolic acid market growth?

A: North America is expected to lead in terms of revenue growth, followed by Europe and the Asia Pacific region[1][3].

Q: What are the driving factors for the mycophenolic acid market?

A: The market is driven by increasing demand for organ transplants, the rising prevalence of autoimmune diseases, technological advancements in drug formulations, and growing investments in healthcare infrastructure[2][5].

Q: What are the potential challenges for the mycophenolic acid market?

A: High costs associated with the drug, potential side effects, and lack of awareness in some regions are potential challenges for the market[4].

Q: Which companies are key players in the mycophenolic acid market?

A: Key players include Roche Holding AG, Novartis AG, Mylan N.V., Lupin Limited, and Teva Pharmaceutical Industries Ltd. among others[2].

Sources

1. Drug Patent Watch: MYCOPHENOLIC ACID DR Market Analysis and Financial Projection[1].
2. Market Research Intellect: Mycophenolic Acid Market Size and Projections[2].
3. Reports and Data: Mycophenolic Acid Market Size, Share, Trends and Forecast by 2030[3].
4. Data Bridge Market Research: Global Mycophenolate Market - Industry Trends and Forecast to 2029[4].
5. Cognitive Market Research: Mycophenolic Acid Market Report 2025 (Global Edition)[5].