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Compound · clinical trials

Mycophenolate Mofetil clinical trials

Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 12 trials in our China, USA, UK and India registers that name Mycophenolate Mofetil as an intervention. Synced 26 Sep 2026
12Current trials
8Recruiting now
12Lead sponsors
4Country registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 โ€” Top 14 finalist
Compiled from ClinicalTrials.gov registry records ยท Last verified ยท Editorial standards
At a glance

Mycophenolate Mofetil is named as an intervention in 12 current clinical trials in our China, USA, UK and India registers. 8 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Sanofi (1). The most-studied condition is Kidney Transplant Rejection. The EU clinical trials register (CTIS) separately lists 5 authorised or ongoing trials.

Trials by status

  • Recruiting867%
  • Not yet open217%
  • Active, closed217%

Trials by phase

  • Phase 2433%
  • Phase 3433%
  • Not applicable217%
  • Phase 2/318%
  • Phase 418%
01

Clinical trials of Mycophenolate Mofetil

12 trials
StudyPhaseStatusLead sponsorRegisters
A Study to Evaluate the Benefits and Risks of Conversion of Existing Adolescent Kidney Transplant Recipients Aged 12 to <18 Years to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications
NCT04877288 · ClinicalTrials.gov ↗ · Renal Allograft Recipients
Phase 3 Recruiting Bristol-Myers Squibb UK, USA
A Study of Tacrolimus/Methotrexate/Ruxolitinib Versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation (BMT CTN 2203)
NCT06615050 · ClinicalTrials.gov ↗ · Graft-versus-host Disease (GVHD)
Phase 3 Recruiting Incyte Corporation USA
Evaluation of Rovadicitinib Compared to the Protocol Selected by Researchers in Third Line and Subsequent Studies of Moderate to Severe Chronic Graft-versus-host Disease
NCT06682169 · ClinicalTrials.gov ↗ · Graft-versus-host Disease
Phase 3 Recruiting Chia Tai Tianqing Pharmaceutical Group Co., Ltd China
A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation
NCT07412470 · Kidney Transplant Rejection
Phase 2/3 Recruiting Sanofi UK, USA, China
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants
NCT05039619 · ClinicalTrials.gov ↗ · Lupus Nephritis
Phase 2 Recruiting Hoffmann-La Roche UK, USA
Efficacy and Safety of Telitacicept in the Treatment of Systemic Sclerosis
NCT06375005 · ClinicalTrials.gov ↗ · Diffuse Cutaneous Systemic Sclerosis
Phase 2 Recruiting Second Affiliated Hospital, Zhejiang University, School of Medicine China
The Efficacy and Safety of Biologics (Belimumab/ Telitacicept) Induction Therapy in Proliferative Lupus Nephritis Patients for 6 Months Compared With Mycophenolate Mofetil Treatment
NCT07340463 · ClinicalTrials.gov ↗ · Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN)
Phase 2 Recruiting Nanjing University School of Medicine China
Short-term Glucocorticoid Combined with MMF for IgG4-RD
NCT06663618 · ClinicalTrials.gov ↗ · IgG4-related Disease
Not applicable Recruiting Wen Zhang China
Allogeneic Hematopoietic Stem Cell Transplantation for 4/M Neuroblastoma
NCT05303727 · ClinicalTrials.gov ↗ · Neuroblastoma
Phase 2 Not yet open Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University China
Randomized Controlled Trial of Mycophenolate Mofetil Versus Steroid Therapy in Alcoholic Hepatitis
NCT06789315 · ClinicalTrials.gov ↗ · Alcoholic Hepatitis
Not applicable Not yet open Institute of Liver and Biliary Sciences, India India
An RCT of Mycophenolate Mofetil (MMF) in Fibrotic Hypersensitivity Pneumonitis
NCT05626387 · ClinicalTrials.gov ↗ · Hypersensitivity Pneumonitis
Phase 4 Active, closed Post Graduate Institute of Medical Education and Research, Chandigarh India
A Study Comparing Haploidentical Hematopoietic Stem Cell Transplantations (HSCTs) From Young Non-first-degree and Older First-degree Donors in Hematological Malignancies
NCT04547049 · ClinicalTrials.gov ↗ · Leukemia, MDS
Phase 3 Active, closed First Affiliated Hospital of Zhejiang University China

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Mycophenolate Mofetil in the EU trials register (CTIS)

5 trials

Authorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Mycophenolate Mofetil. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.

StudyPhaseStatusSponsorCountries
A Phase III, Open-Label, Randomised, Multicentre, Global Study of Adjuvant Datopotamab Deruxtecan in Combination With Rilvegostomig in Participants With High-risk Muscle Invasive Urothelial Carcinoma (TROPION-Urothelial04).
2025-525030-57-00 · Neoplasms
Phase 3 Authorised AstraZeneca AB Italy, Poland, Spain + 1 more
Influence of Antimicrobial Drugs on Mycophenolic acid and Tacrolimus Pharmacokinetics and the Gut Microbiome in Kidney Transplant Recipients (AXIS)
2026-527106-20-00 · Microbiological Phenomena
Phase 4 Authorised Oslo Universitetssykehus HF Norway
FLUDARABINE-TREOSULFAN REDUCED INTENSITY CONDITIONING REGIMEN PRIOR HAPLOIDENTICAL STEM CELL TRANSPLANTATION WITH POST TRANSPLANTATION CYCLOPHOSPHAMIDE FOR OLDER AND/OR FRAIL PATIENTS WITH AML
2025-523632-39-00 · Neoplasms
Phase 2 Authorised Institut Paoli Calmettes France
A Master Protocol of a Phase II, Open-label, Multicenter, Global Platform Study to Evaluate the Safety and Efficacy of Immunotherapy With or Without Other Anticancer Drugs in Participants with Unresectable Stage III Non-small Cell Lung Cancer Planning to Undergo Concurrent Chemoradiotherapy (AQUARIUS)
2025-523599-21-00 · CTIS ↗ · Neoplasms
Phase 2 Authorised AstraZeneca AB Spain, Germany
A Master Protocol of an Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumour Activity of Novel Combinations in Participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (LIBRA)
2025-524843-11-00 · CTIS ↗ · Neoplasms
Phase 2 Ongoing AstraZeneca AB France, Italy, Spain
03

Mycophenolate Mofetil across our data

Ireland · EU · US

The same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.

Licensed in Ireland (HPRA)

17 single-substance products containing Mycophenolate Mofetil on the HPRA medicines list.

All 17 Irish products →

Supply shortages

No entry for Mycophenolate Mofetil in the EMA, FDA or German BfArM shortage lists we track.

Recent approvals

  • Mycophenolate Mofetil HydrochlorideFDA · 1 Jun 2023 · Generic (ANDA) · Bpi Labs
  • Mycophenolate Mofetil HydrochlorideFDA · 23 Dec 2022 · Generic (ANDA) · Onesource Specialty
  • Mycophenolate Mofetil HydrochlorideFDA · 28 Oct 2016 · Generic (ANDA) · Ph Health
  • Mycophenolate MofetilFDA · 10 Jun 2010 · Generic (ANDA) · Strides Pharma
  • Mycophenolate MofetilFDA · 22 Dec 2009 · Generic (ANDA) · Strides Pharma Intl
  • Mycophenolate MofetilFDA · 6 May 2009 · Generic (ANDA) · Teva Pharms
  • Mycophenolate MofetilFDA · 4 May 2009 · Generic (ANDA) · Mylan
  • Mycophenolate MofetilFDA · 4 May 2009 · Generic (ANDA) · Mylan
04

Conditions studied with Mycophenolate Mofetil

14 conditions
Kidney Transplant Rejection1Lupus Nephritis1Renal Allograft Recipients1Graft-versus-host Disease (GVHD)1Hypersensitivity Pneumonitis1Alcoholic Hepatitis1Graft-versus-host Disease1Neuroblastoma1Leukemia1MDS1IgG4-related Disease1Systemic Lupus Erythematosus (SLE)1
All 14 conditions
Condition (as registered)Trials
Kidney Transplant Rejection1
Lupus Nephritis1
Renal Allograft Recipients1
Graft-versus-host Disease (GVHD)1
Hypersensitivity Pneumonitis1
Alcoholic Hepatitis1
Graft-versus-host Disease1
Neuroblastoma1
Leukemia1
MDS1
IgG4-related Disease1
Systemic Lupus Erythematosus (SLE)1
Lupus Nephritis (LN)1
Diffuse Cutaneous Systemic Sclerosis1
05

Sponsors

lead sponsor per trial
Lead sponsorTrials
Sanofi1
Hoffmann-La Roche1
Bristol-Myers Squibb1
Incyte Corporation1
Post Graduate Institute of Medical Education and Research, Chandigarh1
Institute of Liver and Biliary Sciences, India1
Chia Tai Tianqing Pharmaceutical Group Co., Ltd1
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1
First Affiliated Hospital of Zhejiang University1
Wen Zhang1
Nanjing University School of Medicine1
Second Affiliated Hospital, Zhejiang University, School of Medicine1
06

By country register

RegisterTrialsRecruiting
Clinical trials in China75
Clinical trials in USA44
Clinical trials in UK33
Clinical trials in India20
EU register (CTIS)5—

A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.

07

Related compounds

08

Questions about Mycophenolate Mofetil trials

How many clinical trials are testing Mycophenolate Mofetil?

12 current trials in our China, USA, UK and India registers name Mycophenolate Mofetil as a drug or biological intervention, as of the registry sync on 26 September 2026. Completed and withdrawn studies are not counted.

Are Mycophenolate Mofetil trials recruiting patients?

Yes. 8 of the 12 trials are recruiting: 5 with sites in China, 4 with sites in USA and 3 with sites in UK. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Mycophenolate Mofetil clinical trials?

Sanofi (1), Hoffmann-La Roche (1), Bristol-Myers Squibb (1) and Incyte Corporation (1), among 12 lead sponsors in total. The number in brackets is how many trials each organisation leads.

Is Mycophenolate Mofetil licensed in Ireland?

Yes. The HPRA medicines list includes 17 single-substance products containing Mycophenolate Mofetil, for example Mycolat 250 mg hard capsules (Rowex Limited,). A licence does not mean a product is currently marketed or reimbursed; see each product's record.

Is there a Mycophenolate Mofetil shortage?

Not in the lists we track: Mycophenolate Mofetil has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Mycophenolate Mofetil works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records โ€” it is not written from memory, and nothing here describes how Mycophenolate Mofetil works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Mycophenolate Mofetil (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 26 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician โ€” our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us โ€” we correct promptly and log it.