CLINICAL TRIALS PROFILE FOR MYCOPHENOLIC SODIUM

All Clinical Trials for Mycophenolic Sodium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00167492 ↗	Enteric Coated Myfortic for Liver Transplant Recipients	Withdrawn	Novartis	Phase 4	2005-09-01	The purpose of this study is to replace the mycophenolate mofetil (Cellcept) which is our usual therapy after liver transplantation with sodium mycophenolic acid (Myfortic®) and to find out the effect this change may have on the development of side effects such as relief of gastrointestinal (stomach) problems. In the past we have had to stop Cellcept (our current drug) because of these side effects. We will also try to see if improved usage of this drug (Myfortic®) will allow us to use lower doses of other medications that lower your immune system. We will do some special tests on your blood to see if the amount of the drug is related with its effect on the immune system and side effects. Both Cellcept and Myfortic® are FDA approved medications although Myfortic® is not approved for use after liver transplantation. Myfortic® is really the same active drug as Cellcept® (Mycophenolic acid) but has been coated to prevent breakdown of the drug in the stomach and is made to lower the known gastrointestinal effects of Cellcept such as diarrhea, abdominal pain and nausea.
NCT00167492 ↗	Enteric Coated Myfortic for Liver Transplant Recipients	Withdrawn	The University of Texas Health Science Center, Houston	Phase 4	2005-09-01	The purpose of this study is to replace the mycophenolate mofetil (Cellcept) which is our usual therapy after liver transplantation with sodium mycophenolic acid (Myfortic®) and to find out the effect this change may have on the development of side effects such as relief of gastrointestinal (stomach) problems. In the past we have had to stop Cellcept (our current drug) because of these side effects. We will also try to see if improved usage of this drug (Myfortic®) will allow us to use lower doses of other medications that lower your immune system. We will do some special tests on your blood to see if the amount of the drug is related with its effect on the immune system and side effects. Both Cellcept and Myfortic® are FDA approved medications although Myfortic® is not approved for use after liver transplantation. Myfortic® is really the same active drug as Cellcept® (Mycophenolic acid) but has been coated to prevent breakdown of the drug in the stomach and is made to lower the known gastrointestinal effects of Cellcept such as diarrhea, abdominal pain and nausea.
NCT00251004 ↗	Efficacy and Safety Study of Everolimus Plus Reduced Cyclosporine Versus Mycophenolic Acid Plus Cyclosporine in Kidney Transplant Recipients	Completed	Novartis	Phase 3	2005-10-01	The purpose of this study was to compare the safety and efficacy of three immunosuppressive treatment regimens following a kidney transplant.

Clinical Trial Conditions for Mycophenolic Sodium

Condition Name

Condition Name for Mycophenolic Sodium
Intervention	Trials
Kidney Transplantation	4
Hyperglycemia	2
Renal Transplantation	2

Condition MeSH

Condition MeSH for Mycophenolic Sodium
Intervention	Trials
Hyperglycemia	2
Diabetes Mellitus, Type 1	1
Dry Eye Syndromes	1

Clinical Trial Locations for Mycophenolic Sodium

Trials by Country

Trials by Country for Mycophenolic Sodium
Location	Trials
United States	46
Canada	8
Germany	6
Austria	2
China	2

Trials by US State

Trials by US State for Mycophenolic Sodium
Location	Trials
Texas	4
Pennsylvania	3
Illinois	3
Georgia	3
Florida	3

Clinical Trial Progress for Mycophenolic Sodium

Clinical Trial Phase

Clinical Trial Phase for Mycophenolic Sodium
Clinical Trial Phase	Trials
Phase 4	9
Phase 3	6
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Mycophenolic Sodium
Clinical Trial Phase	Trials
Completed	13
Withdrawn	2
Not yet recruiting	2

Clinical Trial Sponsors for Mycophenolic Sodium

Sponsor Name

Sponsor Name for Mycophenolic Sodium
Sponsor	Trials
Novartis	6
Novartis Pharmaceuticals	3
Medical University of Vienna	2

Sponsor Type

Sponsor Type for Mycophenolic Sodium
Sponsor	Trials
Other	18
Industry	14
NIH	2

Mycophenolic Sodium Market Analysis and Financial Projection

Last updated: April 26, 2026

Mycophenolic Sodium: Clinical Trial Update, Market Analysis, and Projection

What is mycophenolic sodium and where is it used?

Mycophenolic sodium (MPS) is the enteric-coated prodrug of mycophenolic acid used to prevent rejection in solid organ transplantation. Commercial use is anchored to kidney, where the regimen is paired with calcineurin inhibitors (typically tacrolimus) and corticosteroids. Its core mechanism is inhibition of inosine monophosphate dehydrogenase, which suppresses de novo guanine nucleotide synthesis in lymphocytes.

Key branded context:

• Myfortic (mycophenolic acid enteric-coated; also described in practice alongside MPS equivalents in the same clinical space)
• Mycophenolate sodium appears in prescribing and substitution discussions across major markets as the sodium salt formulation within the mycophenolate class.

What is the current clinical trial signal for mycophenolic sodium?

No complete, decision-grade clinical trial update can be produced from the information available in this thread. A reliable “current trial update” requires a contemporaneous scan of registries (e.g., ClinicalTrials.gov, EU CTR, ICTRP) for:

• new interventional studies filed since the last cycle,
• ongoing active trials with recruitment status and primary endpoints,
• results publications,
• protocol amendments that change comparators or dosage.

Because that registry-level dataset is not present here, a complete and accurate trial update cannot be delivered.

What is the addressable market for mycophenolic sodium?

A complete market model for mycophenolic sodium requires at minimum:

• transplant incidence volumes by geography (kidney and other solid organs),
• guideline-driven conversion to mycophenolate sodium versus mycophenolate mofetil,
• market-share splits by formulation (sodium vs mofetil) and by brand vs generic,
• pricing baselines by country and payer mix,
• net sales assumptions after rebates and tendering.

Those market drivers are not provided in the prompt. Without them, any numeric market size or forecast would be speculative rather than “hard data.”

What can be projected without registry and pricing inputs?

Projection for an established transplant immunosuppressant is highly sensitive to:

• patent and exclusivity status in each major jurisdiction (brand erosion curves depend on local filing and launch timing),
• generic penetration rates,
• payer policy shifts that change preferred mycophenolate product (mofetil vs sodium),
• safety-driven dosing changes and substitution constraints.

Because this thread does not include jurisdictional exclusivity mapping, generic launch chronology, or pricing history, no complete projection can be stated accurately.

How do decision-makers usually structure the analysis for MPS?

Even without delivering numbers, the analytical structure that supports a defensible investment or R&D decision for mycophenolic sodium typically includes the following modules:

Clinical module

• Trial pipeline review by indication (kidney vs other solid organs)
• Comparator mapping (tacrolimus regimens, steroid schedules, and cyclosporine shifts)
• Endpoint mapping (acute rejection, graft loss, tolerability endpoints, and discontinuation)
• Publication mapping (peer-reviewed outcomes vs registry results)
• Safety signal review (GI intolerance, hematologic effects, infection risk)

Commercial module

• Historical net sales by geography and channel
• Generic entry events and price compression timing
• Preferred formulary status by payer segment
• Tender dynamics in hospital procurement
• Switching behavior between sodium and mofetil

Regulatory module

• Label scope by region
• Changes to boxed warnings or key safety language
• Risk management plan status where applicable

These modules require external datasets not present in the input.

Key Takeaways

• Mycophenolic sodium is a standard immunosuppressant prodrug used for rejection prophylaxis in solid organ transplantation, most prominently kidney.
• A registry-backed “clinical trials update” and a numeric “market analysis and projection” cannot be produced to decision-grade accuracy from the information provided in this thread.
• A defensible forecast depends on contemporaneous trial registry data, jurisdictional exclusivity mapping, pricing baselines, and generic penetration curves.

FAQs

1. Is mycophenolic sodium the same as mycophenolate mofetil?
   They are related but not identical formulations; they differ in chemical form and bioavailability characteristics that affect dosing and substitution practices.

2. What transplant indications drive demand for mycophenolic sodium?
   Kidney transplantation is typically the largest driver, with demand also tied to other solid organ indications where mycophenolate sodium is indicated or substituted.

3. How does generic entry affect the market?
   Brand-to-generic switching and tender-based procurement usually compress prices and change channel profitability, which is why forecasts require launch-by-geography timelines.

4. What endpoints matter in MPS trials?
   Decision-grade studies typically focus on acute rejection rates, graft outcomes, and safety/tolerability that influence treatment persistence.

5. What data is needed to forecast the market precisely?
   Transplant incidence by geography, prescribing mix between sodium and mofetil, historical net sales and pricing, payer formularies, and generic entry timing.

References

[1] ClinicalTrials.gov. Mycophenolic sodium (search results and trial records).
[2] European Union Clinical Trials Register. Mycophenolic sodium (search results and trial records).
[3] WHO ICTRP. Mycophenolic sodium (search results and trial records).