Mycophenolate Mofetil

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Cat Number

API115007346

CAS Number

128794-94-5

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CAS Number

128794-94-5

EINECS

627-027-6

Storage

Store at room temperature

Synonyms

Myfenax; RS-61443; myclausen; Mycophenylate mofetil

Molecular Formula

C23H31NO7

Molecular Weight

433.5

Smiles

CC1=C2COC(=O)C2=C(C(=C1OC)C/C=C(\C)/CCC(=O)OCCN3CCOCC3)O

Appearance

White to off-white crystalline powder

Melting Point

95-96°C

Boiling Point

637.6±55.0°C at 760 mmHg (Predicted)

Relative Density

1.222±0.06 (Predicted)

General Description

Mycophenolate mofetil is a synthetic morpholinoethyl ester prodrug of mycophenolic acid, an immunosuppressant agent. Its chemical structure is 2-morpholinoethyl (E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoate. Mycophenolate mofetil is a white to off-white powder, practically insoluble in water but soluble in organic solvents.

Mechanism of Action

Mycophenolate mofetil is hydrolyzed to mycophenolic acid, which inhibits the enzyme inosine monophosphate dehydrogenase (IMPDH), a key enzyme in the de novo synthesis of guanine nucleotides. This leads to the depletion of guanosine nucleotides, which is essential for the proliferation of T and B lymphocytes. The drug selectively targets lymphocytes, reducing the immune response.

Application

Mycophenolate mofetil is indicated for the prophylaxis of organ rejection in patients receiving kidney, heart, or liver transplants. It is used in combination with cyclosporine and corticosteroids. The drug is also used for the treatment of autoimmune diseases, such as systemic lupus erythematosus and dermatomyositis.

In a randomized trial of 170 patients with high-risk IgA nephropathy (eGFR 30-60, proteinuria >1 g/d), adding mycophenolate mofetil (MMF) to supportive care significantly reduced the primary composite outcome (doubling of serum creatinine, ESKD, or kidney/cardiovascular death) (7.1% vs 21.2%, aHR 0.23, 95% CI 0.09-0.63) and CKD progression (8.2% vs 27.1%, aHR 0.23, 95% CI 0.10-0.57). eGFR loss accelerated after MMF discontinuation during post-trial follow-up. MMF plus supportive care significantly reduces disease progression in progressive IgAN.

Fig. 1 Primary Outcomes by Prespecified Subgroup at Baseline. (Hou FF, et al., 2023)

References

Hou FF, et al. Effectiveness of Mycophenolate Mofetil Among Patients With Progressive IgA Nephropathy: A Randomized Clinical Trial. JAMA Netw Open. 2023;6(2):e2254054.

Mycophenolic acid (MPA), the active metabolite of mycophenolate mofetil, reduced viability and induced apoptosis in human monocytes and macrophages at concentrations achieved in systemic sclerosis patients. It attenuated IL‑4 and SSc plasma‑driven macrophage activation and inhibited their ability to activate fibroblasts. Gene expression studies showed reduced dermal myeloid signatures in MMF‑responsive patients. MMF directly inhibits monocyte/macrophage pro‑fibrotic activation, contributing to its antifibrotic effects.

Fig. 2 Mycophenolic acid (MPA) reduced viability and induced apoptosis in human monocytes and macrophages. (Morris EA, et al., 2025)

References

Morris EA, et al. Mycophenolate mofetil directly modulates myeloid viability and pro-fibrotic activation of human macrophages. Rheumatology (Oxford). 2025;64(5):3125-3133.

Does Mycophenolate Mofetil require protection from moisture during storage?

Yes, it is hygroscopic and susceptible to hydrolysis of the morpholinoethyl ester. Store in tightly sealed, moisture-proof containers with desiccant.

What is the recommended storage temperature for Mycophenolate Mofetil?

Store at controlled room temperature (15–25°C). Avoid temperatures above 30°C, which accelerate degradation and formation of mycophenolic acid.

Is Mycophenolate Mofetil stable in tablet and suspension formulations?

Tablets are stable when protected from moisture. Reconstituted suspensions have limited stability (typically 7–14 days under refrigeration).

How is the impurity mycophenolic acid (a hydrolysis product) monitored?

This primary degradation product is specifically quantified using a stability-indicating HPLC method, ensuring it remains within ICH limits.