Mycophenolic acid

Mycophenolic, Myfortic (mycophenolic acid) is a small molecule pharmaceutical. Mycophenolic acid was first approved as Myfortic on 2004-02-27. It is used to treat graft vs host disease and psoriasis in the USA. The pharmaceutical is active against inosine-5'-monophosphate dehydrogenase 1 and inosine-5'-monophosphate dehydrogenase 2.

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
skin and connective tissue diseases	D017437
immune system diseases	D007154

Trade Name

FDA

EMA

Mycophenolate, Myfortic (discontinued: Mycophenolate)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Mycophenolate sodium

Tradename	Company	Number	Date	Products
MYFORTIC	Novartis	N-050791 RX	2004-02-27	2 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
cellcept	New Drug Application	2025-11-25
mycophenolate mofetil	ANDA	2026-06-12
mycophenolic acid	ANDA	2026-06-15
myfortic	New Drug Application	2025-12-09
myhibbin	New Drug Application	2026-04-01

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
psoriasis	EFO_0000676	D011565	L40
graft vs host disease	—	D006086	D89.81

Agency Specific

FDA

EMA

No data

Patent Expiration

No data

ATC Codes

L: Antineoplastic and immunomodulating agents

— L04: Immunosuppressants

— L04A: Immunosuppressants

— L04AA: Selective immunosuppressants

— L04AA06: Mycophenolic acid

HCPCS

Code	Description
J7518	Mycophenolic acid, oral, 180 mg

Clinical

Clinical Trials

1371 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Kidney transplantation	D016030	—	—	20	53	55	123	30	267
Leukemia	D007938	—	C95	37	115	11	2	14	161
Graft vs host disease	D006086	—	D89.81	19	47	16	6	7	84
Lupus nephritis	D008181	EFO_0005761	—	1	20	19	9	15	63
Liver transplantation	D016031	EFO_0010682	—	2	14	11	17	6	48
Graft rejection	D006084	—	—	2	11	5	16	12	43
Renal insufficiency	D051437	—	N19	10	11	9	14	5	42
Immunosuppression therapy	D007165	—	—	2	2	2	16	18	40
Chronic kidney failure	D007676	EFO_0003884	N18.6	10	11	3	14	9	39
Recurrence	D012008	—	—	8	26	2	1	6	39

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Myelodysplastic syndromes	D009190	—	D46	47	130	7	—	16	180
Myeloid leukemia acute	D015470	—	C92.0	34	111	13	—	11	154
Precursor cell lymphoblastic leukemia-lymphoma	D054198	—	C91.0	24	84	9	—	10	117
Lymphoma	D008223	—	C85.9	23	80	3	—	11	107
Non-hodgkin lymphoma	D008228	—	C85.9	19	75	7	—	10	100
Multiple myeloma	D009101	—	C90.0	24	69	5	—	12	100
B-cell chronic lymphocytic leukemia	D015451	—	C91.1	14	68	5	—	8	87
Hodgkin disease	D006689	—	C81	18	64	5	—	9	87
Bcr-abl positive chronic myelogenous leukemia	D015464	EFO_0000340	—	14	66	6	—	5	83
Myeloproliferative disorders	D009196	—	D47.1	14	51	5	—	7	71

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Aplastic anemia	D000741	—	D61.9	5	24	—	—	5	31
T-cell lymphoma	D016399	—	—	5	19	—	—	3	24
Congenital abnormalities	D000013	EFO_0003915	Q89.9	6	15	—	—	4	23
Plasmacytoma	D010954	—	C90.3	6	16	—	—	4	23
B-cell lymphoma	D016393	—	—	4	17	—	—	3	22
Sezary syndrome	D012751	—	C84.1	4	15	—	—	4	21
Mycosis fungoides	D009182	—	C84.0	4	15	—	—	4	21
T-cell lymphoma cutaneous	D016410	—	C84.A	5	15	—	—	4	21
Large-cell lymphoma anaplastic	D017728	—	C84.6	4	15	—	—	3	20
Sickle cell anemia	D000755	EFO_0000697	D57	8	12	—	—	2	19

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Islets of langerhans transplantation	D016381	—	—	1	—	—	—	2	3
Brain neoplasms	D001932	EFO_0003833	C71	2	—	—	—	—	2
Astrocytoma	D001254	EFO_0000271	—	2	—	—	—	—	2
Chronic granulomatous disease	D006105	EFO_0000338	D71	1	—	—	—	1	2
Glioma	D005910	EFO_0000520	—	1	—	—	—	—	1
Germ cell and embryonal neoplasms	D009373	—	—	1	—	—	—	—	1
Medulloblastoma	D008527	—	—	1	—	—	—	—	1
Rhabdoid tumor	D018335	—	—	1	—	—	—	—	1
Ependymoma	D004806	—	—	1	—	—	—	—	1
Choroid plexus neoplasms	D016545	EFO_0007206	—	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Uveomeningoencephalitic syndrome	D014607	Orphanet_3437	H20.82	—	—	—	—	3	3
Muscle weakness	D018908	—	—	—	—	—	—	2	2
Thrombocytopenic purpura	D011696	—	—	—	—	—	—	2	2
Purpura	D011693	HP_0000979	D69.2	—	—	—	—	2	2
Heart disease risk factors	D000082742	—	—	—	—	—	—	1	1
Bone diseases	D001847	—	M89.9	—	—	—	—	1	1
Antibody formation	D000917	—	—	—	—	—	—	1	1
Choroidal neovascularization	D020256	—	—	—	—	—	—	1	1
Hemorrhage	D006470	MP_0001914	R58	—	—	—	—	1	1
Blood coagulation disorders	D001778	EFO_0009314	D68.9	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Mycophenolic acid
INN	mycophenolic acid
Description	Mycophenolic acid is a member of the class of 2-benzofurans that is 2-benzofuran-1(3H)-one which is substituted at positions 4, 5, 6, and 7 by methyl, methoxy, (2E)-5-carboxy-3-methylpent-2-en-1-yl, and hydroxy groups, respectively. It is an antibiotic produced by Penicillium brevi-compactum, P. stoloniferum, P. echinulatum and related species. An immunosuppressant, it is widely used (partiularly as its sodium salt and as the 2-(morpholin-4-yl)ethyl ester prodrug, mycophenolate mofetil) to prevent tissue rejection following organ transplants and for the treatment of certain autoimmune diseases. It has a role as an antineoplastic agent, an antimicrobial agent, an EC 1.1.1.205 (IMP dehydrogenase) inhibitor, an immunosuppressive agent, a mycotoxin, a Penicillium metabolite, an environmental contaminant, a xenobiotic and an anticoronaviral agent. It is a gamma-lactone, a member of phenols, a monocarboxylic acid and a member of 2-benzofurans. It is functionally related to a hex-4-enoic acid. It is a conjugate acid of a mycophenolate.
Classification	Small molecule
Drug class	—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	COc1c(C)c2c(c(O)c1C/C=C(\C)CCC(=O)O)C(=O)OC2

Identifiers

PDB	—
CAS-ID	24280-93-1
RxCUI	—
ChEMBL ID	CHEMBL866
ChEBI ID	168396
PubChem CID	446541
DrugBank	DB01024
UNII ID	HU9DX48N0T (ChemIDplus, GSRS)

Target

Agency Approved

IMPDH1

Organism

Homo sapiens

Gene name

IMPDH1

Gene synonyms

IMPD1

NCBI Gene ID

3614

Protein name

inosine-5'-monophosphate dehydrogenase 1

Protein synonyms

IMP (inosine 5'-monophosphate) dehydrogenase 1, IMP (inosine monophosphate) dehydrogenase 1, IMPD 1, IMPDH 1, IMPDH-I

Uniprot ID

P20839

Mouse ortholog

Impdh1 (23917)

inosine-5'-monophosphate dehydrogenase 1 (P50096)

Alternate

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Variants

No data

Financial

Revenue by drug

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Cellcept – Roche

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Myfortic – Novartis

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Estimated US medical usage

Mycophenolic acid

Total medical expenditures per year (USD, in millions)

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Number of persons purchased

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Trends

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Safety

Black-box Warning

Black-box warning for: Cellcept, Mycophenolate mofetil, Mycophenolic acid, Myfortic, Myhibbin

Adverse Events

Top Adverse Reactions

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132,995 adverse events reported

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