Apremilast
- Generic Name
- Apremilast
- Brand Names
- Otezla, Apremilast Accord
- Drug Type
- Small Molecule
- Chemical Formula
- C22H24N2O7S
- CAS Number
- 608141-41-9
- Unique Ingredient Identifier
- UP7QBP99PN
- Background
Apremilast, also known as Otezla, is a phosphodiesterase 4 (PDE4) inhibitor used to treat various types of symptoms resulting from certain inflammatory autoimmune diseases. It belongs to the same drug class as Roflumilast and Crisaborole. Initially approved in 2014, it is marketed by Celgene. In July 2019, apremilast was granted a new FDA approval for the treatment of oral ulcers associated with Behcet's disease, an autoimmune condition that causes recurrent skin, blood vessel, and central nervous system inflammation.
- Indication
Apremilast is indicated for the treatment of adults with active psoriatic arthritis and adults with oral ulcers associated with Behcet's Disease. In addition, apremilast is indicated for the treatment of plaque psoriasis, of any severity, in adult patients who are candidates for phototherapy or systemic therapy.
- Associated Conditions
- Psoriasis Vulgaris (Plaque Psoriasis), Active Psoriatic arthritis, Ulceration of the mouth
Comparison of Otezla to SFA-002 to Placebo in Plaque Psoriasis Patients
- First Posted Date
- 2025-03-07
- Last Posted Date
- 2025-03-11
- Lead Sponsor
- SFA Therapeutics
- Target Recruit Count
- 125
- Registration Number
- NCT06863493
A Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001
- First Posted Date
- 2024-09-19
- Last Posted Date
- 2025-04-25
- Lead Sponsor
- Alumis Inc
- Target Recruit Count
- 840
- Registration Number
- NCT06588738
- Locations
- 🇭🇺
Orvostudomanyi Kutato es Fejleszto Kft, Debrecen, Hungary
🇭🇺Allergo Derm Bakos Kft, Szolnok, Hungary
🇭🇺Medmare Bt, Veszprém, Hungary
A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis
- First Posted Date
- 2024-09-19
- Last Posted Date
- 2025-05-14
- Lead Sponsor
- Alumis Inc
- Target Recruit Count
- 840
- Registration Number
- NCT06586112
- Locations
- 🇺🇸
Alliance Dermatology, Phoenix, Arizona, United States
🇺🇸Scottsdale Clinical Trials, Scottsdale, Arizona, United States
🇺🇸Northwest Arkansas Clinical Trials Center (NWACTC), PLLC, Rogers, Arkansas, United States
A 20-Week Study Assessing the Efficacy of Apremilast in Patients with EB Simplex Generalized
- Conditions
- Epidermolysis Bullosa SimplexGenodermatosis
- Interventions
- First Posted Date
- 2024-07-19
- Last Posted Date
- 2025-02-24
- Lead Sponsor
- Centre Hospitalier Universitaire de Nice
- Target Recruit Count
- 20
- Registration Number
- NCT06509984
- Locations
- 🇫🇷
CHU de Nice, Nice, France
🇫🇷APHP Necker-Enfants-Malades, Paris, France
🇫🇷APHP Hôpital Saint-Louis, Paris, France
A Study of the Comparative Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in Japan (RePhlect)
- First Posted Date
- 2024-04-25
- Last Posted Date
- 2024-04-25
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 600
- Registration Number
- NCT06382987
- Locations
- 🇯🇵
Mebix. Inc., Minato-ku, Tokyo, Japan
🇯🇵Fukuoka University Hospital, Fukuoka, Japan
Apremilast for Alcohol Use Disorder Treatment in Women and Men
- First Posted Date
- 2024-03-22
- Last Posted Date
- 2025-03-03
- Lead Sponsor
- Yale University
- Target Recruit Count
- 10
- Registration Number
- NCT06324435
- Locations
- 🇺🇸
Yale University, New Haven, Connecticut, United States
Efficacy and Safety of add-on Apremilast Versus add-on Methotrexate in Patients With Oral Lichen Planus
- Conditions
- Oral Lichen Planus
- Interventions
- First Posted Date
- 2024-02-15
- Last Posted Date
- 2024-02-15
- Lead Sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Target Recruit Count
- 64
- Registration Number
- NCT06260904
- Locations
- 🇮🇳
AIIMS Bhubaneswar, Bhubaneswar, Odisha, India
A Study to Investigate Efficacy and Safety of Apremilast 30 mg Twice Daily (BID) in Chinese Participants With Moderate to Severe Plaque-type Psoriasis (PsO)
- First Posted Date
- 2023-11-08
- Last Posted Date
- 2025-03-13
- Lead Sponsor
- Amgen
- Target Recruit Count
- 203
- Registration Number
- NCT06122649
- Locations
- 🇨🇳
Peking University First Hospital, Beijing, Beijing, China
🇨🇳Peking University Third Hospital, Beijing, Beijing, China
🇨🇳The First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China
A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 60 Weeks of Treatment With a Withdrawal and Retreatment Period
- Conditions
- Plaque Psoriasis
- Interventions
- First Posted Date
- 2023-10-31
- Last Posted Date
- 2025-01-27
- Lead Sponsor
- Takeda
- Target Recruit Count
- 1108
- Registration Number
- NCT06108544
- Locations
- 🇺🇸
Advanced Medical Research, PC, Atlanta, Georgia, United States
🇨🇦Skinsense Medical Research - 411 2nd Ave N - Probity - PPDS, Saskatoon, Saskatchewan, Canada
🇵🇱ETG Siedlce - PPDS, Siedlce, Mazowieckie, Poland
A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 52 Weeks of Treatment
- Conditions
- Plaque Psoriasis
- Interventions
- First Posted Date
- 2023-10-18
- Last Posted Date
- 2024-10-16
- Lead Sponsor
- Takeda
- Target Recruit Count
- 693
- Registration Number
- NCT06088043
- Locations
- 🇺🇸
Saguaro Dermatology Associates, LLC - Probity - PPDS, Phoenix, Arizona, United States
🇺🇸First OC Dermatology - Fountain Valley, Fountain Valley, California, United States
🇺🇸Center for Dermatology Clinical Research, Fremont, California, United States
Drug Development Updates
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