Otezla(apremilast)
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 3',5'-cyclic-AMP phosphodiesterase 4B, 3',5'-cyclic-AMP phosphodiesterase 4D, 3',5'-cyclic-AMP phosphodiesterase 4C, and 3',5'-cyclic-AMP phosphodiesterase 4A.
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2Y
5Y
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| musculoskeletal diseases | D009140 |
| skin and connective tissue diseases | D017437 |
Trade Name
FDA
EMA
Apremilast, Otezla (discontinued: Apremilast)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| apremilast | ANDA | 2025-02-19 |
| otezla | New Drug Application | 2025-09-10 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| psoriatic arthritis | EFO_0003778 | D015535 | L40.5 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
APREMILAST, OTEZLA, AMGEN INC | |||
| 2026-07-20 | M-299 | ||
| 2026-07-19 | ODE-248 | ||
| 2024-12-20 | I-884 | ||
HCPCS
No data
Clinical
Clinical Trials
161 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Psoriasis | D011565 | EFO_0000676 | L40 | 1 | 7 | 13 | 3 | 11 | 35 |
| Psoriatic arthritis | D015535 | EFO_0003778 | L40.5 | — | 2 | 7 | 2 | 9 | 20 |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | — | 3 | 6 | 2 | 8 | 19 |
| Parapsoriasis | D010267 | — | L41 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Behcet syndrome | D001528 | EFO_0003780 | M35.2 | — | 1 | 3 | — | 1 | 5 |
| Juvenile arthritis | D001171 | EFO_1002007 | M08 | — | — | 2 | — | — | 2 |
| Oral ulcer | D019226 | — | — | — | — | 2 | — | — | 2 |
| Covid-19 | D000086382 | — | U07.1 | — | — | 1 | — | — | 1 |
| Ankylosing spondylitis | D013167 | EFO_0003898 | M45 | — | — | 1 | — | — | 1 |
| Spondylarthropathies | D025242 | EFO_0000706 | M47 | — | — | 1 | — | — | 1 |
| Spondylarthritis | D025241 | — | — | — | — | 1 | — | — | 1 |
| Spondylitis | D013166 | — | M46.9 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | 2 | — | — | — | 2 |
| Eczema | D004485 | — | L30.9 | — | 2 | — | — | — | 2 |
| Dermatitis | D003872 | — | L30.9 | — | 2 | — | — | — | 2 |
| Female genital diseases | D005831 | EFO_0009549 | N85 | — | 1 | — | — | — | 1 |
| Lichen planus | D008010 | — | L43 | — | 1 | — | — | — | 1 |
| Genital diseases | D000091662 | — | — | — | 1 | — | — | — | 1 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | — | 1 | — | — | — | 1 |
| Colitis | D003092 | EFO_0003872 | K52.9 | — | 1 | — | — | — | 1 |
| Ulcer | D014456 | MPATH_579 | — | — | 1 | — | — | — | 1 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 6 | — | — | — | — | 6 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | — | — | — | — | 1 | 1 |
| Gastrointestinal diseases | D005767 | — | — | — | — | — | — | 1 | 1 |
| Vasculitis | D014657 | EFO_0006803 | M31 | — | — | — | — | 1 | 1 |
| Weight loss | D015431 | — | — | — | — | — | — | 1 | 1 |
| Depression | D003863 | — | F33.9 | — | — | — | — | 1 | 1 |
| Suicidal ideation | D059020 | EFO_0004320 | R45.851 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Apremilast |
| INN | apremilast |
| 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 class | antiasthmatics/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-ID | 608141-41-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL514800 |
| ChEBI ID | 78540 |
| PubChem CID | 11561674 |
| DrugBank | DB05676 |
| UNII ID | UP7QBP99PN (ChemIDplus, GSRS) |
Target
Agency Approved
PDE4B
PDE4B
PDE4D
PDE4D
PDE4A
PDE4A
Organism
Homo sapiens
Gene name
PDE4B
Gene synonyms
DPDE4
NCBI Gene ID
Protein name
3',5'-cyclic-AMP phosphodiesterase 4B; cAMP-specific 3',5'-cyclic phosphodiesterase 4B
Protein synonyms
cAMP-specific phosphodiesterase 4B, DPDE4, dunce-like phosphodiesterase E4, PDE32, phosphodiesterase 4B, cAMP-specific (phosphodiesterase E4 dunce homolog, Drosophila)
Uniprot ID
Mouse ortholog
Pde4b (18578)
3',5'-cyclic-AMP phosphodiesterase 4B (Q9QXI7)
Alternate
No data
Variants
No data
Financial
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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137,676 adverse events reported
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