Wednesday, July 8, 2026

Drug profile · INN

apremilast

apremilast (OTEZLA) is a phosphodiesterase 4 inhibitor. Associated with Amgen. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved PMDA: approved Antineoplastic and immunomodulating agents (L04) L04AA32
US status approved
Patents linked 1
Pipeline programs 8
News articles 0
Drug details — apremilast
US status
approved
Class
Antineoplastic and immunomodulating agents (L04)
Route
ORAL
Patents
1
Programs
8
Data quality
0.89

Quick answer

apremilast (OTEZLA) is a phosphodiesterase 4 inhibitor. Associated with Amgen. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN apremilast
Brand OTEZLA
Mechanism Phosphodiesterase 4 inhibitor
Target Phosphodiesterase 4
Therapeutic class Antineoplastic and immunomodulating agents (L04)
Route ORAL
Formulation TABLET, EXTENDED RELEASE
ATC code L04AA32
Originator Amgen

Mechanism of action

Phosphodiesterase 4 inhibitor

Primary target: Phosphodiesterase 4

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
PMDA approved

Pipeline programs

  1. 20190529 Phase 3 · Amgen · Juvenile psoriatic arthritis
  2. 20190531 Phase 3 · Amgen · Behçet’s disease is a chronic, relapsing, multisystem inflam
  3. Apremilast 20mg Phase 3 · Amgen · Psoriatic Arthritis
  4. IM011-055 Phase 3 · Bristol-Myers Squibb Australia · Active Psoriatic Arthritis
  5. TAK-279-3001 Phase 3 · Takeda · Moderate to Severe Plaque Psoriasis
  6. TAK-279-3002 Phase 3 · Takeda · Moderate to Severe Plaque Psoriasis
  7. TAK-279-PsA-3001 Phase 3 · Takeda · Psoriatic Arthritis
  8. Apremilast Phase 2 · Amgen · Palmoplantaris Pustulosis

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  4. axitinib Antineoplastic and immunomodulating agents (L01)
  5. azacitidine Antineoplastic and immunomodulating agents (L01)
  6. azathioprine Antineoplastic and immunomodulating agents (L04)
  1. MX 2015008685

    TREATMENT OF PSORIATIC ARTHRITIS USING APREMILAST.

    Expires Sun Sep 30 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is apremilast?

apremilast (OTEZLA) is a phosphodiesterase 4 inhibitor. Associated with Amgen. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for apremilast?

OTEZLA is a marketed brand name for apremilast. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of apremilast?

apremilast has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.