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Otezla(apremilast)
Otezla (apremilast) is a small molecule pharmaceutical. Apremilast was first approved as Otezla on 2014-03-21. It is used to treat psoriatic arthritis in the USA. It has been approved in Europe to treat psoriasis and psoriatic arthritis. The pharmaceutical is active against cAMP-specific 3',5'-cyclic phosphodiesterase 4B, cAMP-specific 3',5'-cyclic phosphodiesterase 4D, cAMP-specific 3',5'-cyclic phosphodiesterase 4C, and cAMP-specific 3',5'-cyclic phosphodiesterase 4A.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
musculoskeletal diseasesD009140
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Otezla (generic drugs available since 2021-06-30)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Apremilast
Tradename
Company
Number
Date
Products
OTEZLAAmgenN-205437 RX2014-03-21
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
otezlaNew Drug Application2023-06-05
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
psoriatic arthritisEFO_0003778D015535L40.5
Agency Specific
FDA
EMA
Expiration
Code
APREMILAST, OTEZLA, AMGEN INC
2026-07-19ODE-248
2024-12-20I-884
2023-04-10M-257
Patent Expiration
Patent
Expires
Flag
FDA Information
Apremilast, Otezla, Amgen Inc
98728542034-05-29U-2232, U-2233
100925412034-05-29U-2403, U-2659
74276382028-02-16DS, DP
78931012023-12-09DS, DP
69629402023-03-19U-1504, U-2656, U-2658, U-3276
72085162023-03-19U-1505
76593022023-03-19U-1505, U-1595, U-2658, U-3276
84555362023-03-19U-1505, U-1595, U-2658, U-3276
88027172023-03-19U-1561
90182432023-03-19U-1505, U-1595, U-2656, U-2658, U-3276
97243302023-03-19U-1561, U-1595, U-2656, U-2658, U-3276
ATC Codes
L: Antineoplastic and immunomodulating agents
— L04: Immunosuppressants
— L04A: Immunosuppressants
— L04AA: Selective immunosuppressants
— L04AA32: Apremilast
HCPCS
No data
Clinical
Clinical Trials
124 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PsoriasisD011565EFO_0000676L401101513645
Psoriatic arthritisD015535EFO_0003778L40.5—2105522
Aphthous stomatitisD013281EFO_0003938K12.0——11—2
Erythema nodosumD004893HP_0012219L52———1—1
Cardiovascular diseasesD002318EFO_0000319I98———1—1
ParapsoriasisD010267L41———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Behcet syndromeD001528EFO_0003780M35.2—12—14
Covid-19D000086382U07.1—11——2
Ankylosing spondylitisD013167EFO_0003898M45—11——2
PneumoniaD011014EFO_0003106J18——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Atopic dermatitisD003876EFO_0000274L20—3———3
Rheumatoid arthritisD001172EFO_0000685M06.9—3———3
Lichen planusD008010L43—2———2
PrurigoD011536L28.212———2
DermatomyositisD003882EFO_0000398M33—1——12
VitiligoD014820EFO_0004208L80—2———2
Hidradenitis suppurativaD017497L73.2—2———2
Acne conglobataD000069316L70.1—1———1
Oral lichen planusD017676—1———1
Female genital diseasesD005831EFO_0009549N85—1———1
Show 13 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—8————8
PharmacokineticsD0105991————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Alopecia areataD000506EFO_0004192L63————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAPREMILAST
INNapremilast
Description
Apremilast is a member of the class of isoindoles that is isoindole-1,3-dione substituted at position 4 by an acetamido group and at position 1 by a 1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl group. Used for treatment of psoriatic arthritis. It has a role as a phosphodiesterase IV inhibitor and a non-steroidal anti-inflammatory drug. It is an aromatic ether, a N-acetylarylamine, a sulfone and a member of phthalimides.
Classification
Small molecule
Drug classantiasthmatics/antiallergics (not acting primarily as antihistamines): type IV phosphodiesterase
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CCOc1cc([C@@H](CS(C)(=O)=O)N2C(=O)c3cccc(NC(C)=O)c3C2=O)ccc1OC
Identifiers
PDB—
CAS-ID608141-41-9
RxCUI1492727
ChEMBL IDCHEMBL514800
ChEBI ID78540
PubChem CID11561674
DrugBankDB05676
UNII IDUP7QBP99PN (ChemIDplus, GSRS)
Target
Agency Approved
PDE4B
PDE4B
PDE4D
PDE4D
PDE4C
PDE4C
PDE4A
PDE4A
Organism
Homo sapiens
Gene name
PDE4B
Gene synonyms
DPDE4
NCBI Gene ID
5142
Protein name
cAMP-specific 3',5'-cyclic phosphodiesterase 4B
Protein synonyms
DPDE4, dunce-like phosphodiesterase E4, PDE32, phosphodiesterase 4B, cAMP-specific (phosphodiesterase E4 dunce homolog, Drosophila)
Uniprot ID
Q07343
Mouse ortholog
Pde4b (18578)
cAMP-specific 3',5'-cyclic phosphodiesterase 4B (Q8VBU5)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Otezla - Amgen
$
€
£
₣
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Otezla - Celgene
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,567 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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103,303 adverse events reported
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