Apremilast clinical trials
Apremilast is named as an intervention in 9 current clinical trials in our Spain, France, Italy, Germany, Belgium, Japan, Israel, UK, Turkey, Netherlands, Switzerland, Czechia, Portugal, Canada, Australia, USA, Poland, Ireland, India, China, Mexico, Taiwan and Egypt registers. 7 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Amgen (3). The most-studied condition is Psoriatic Arthritis. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Apremilast is approved
All regulators →Of the three regulators tracked here, the first to approve Apremilast was the US, on 21 Mar 2014. It is approved in 3 of the 3 regulators tracked here.
- 1 EU orphan designation, most recently for treatment of Behçet's Disease (5 Aug 2013, withdrawn)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Apremilast patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Apremilast, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 7 listed patents; the last listed expires 27 May 2042 (US 11752129).
- Latest patent on the drug substance itself: 16 Aug 2028 (US 7427638, with paediatric extension).
- Exclusivity PED: Pediatric exclusivity, until 25 Oct 2027.
- Exclusivity NPP: New patient population, until 25 Apr 2027.
- Exclusivity PED: Pediatric exclusivity, until 20 Jan 2027.
- Exclusivity PED: Pediatric exclusivity, until 19 Jan 2027.
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Apremilast
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Apremilast works
All drug targets →- Phosphodiesterase 4 inhibitor InhibitorTarget: Phosphodiesterase 4✓ In ChEMBL and the Guide to Pharmacology
- COVID-19Phase 3
- Recurrent aphthous stomatitisPhase 3
- Ankylosing spondylitisPhase 3
- Palmoplantar pustulosisPhase 3
- Psoriasis-related juvenile idiopathic arthritisPhase 3
- Skin sarcoidosisPhase 2/3
- AcnePhase 2
- Acute respiratory failurePhase 2
- Alcohol dependencePhase 2
- Allergic contact dermatitisPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL514800, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 7372, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Apremilast
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 3 technology appraisals of Apremilast. 3 are current, and 2 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Apremilast for treating active psoriatic arthritis NICE TA433 | Optimised | 22 Feb 2017 | Current |
| Apremilast for treating moderate to severe plaque psoriasis NICE TA419 | Recommended | 23 Nov 2016 | Current |
| Apremilast for treating moderate to severe plaque psoriasis NICE TA368 | Not recommended | 25 Nov 2015 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Apremilast
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 13 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: Otezla, Apremilast Accord (generic)EMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Apremilast
- ATC code
- L04AA32
- ChEMBL
- CHEMBL514800
- DrugBank
- DB05676
- PubChem CID
- 11561674
- CAS number
- 608141-41-9
- FDA UNII
- UP7QBP99PN
- Wikidata
- Q2858961
- Wikipedia
- Apremilast
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Apremilast
9 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Apremilast in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Apremilast. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
The headache- and migraine-inducing effects of apremilast in women with migraine without aura
2026-525987-16-00 · Nervous System Diseases
|
Phase 1 | Authorised | Syddansk Universitet (University of Southern Denmark) | Denmark |
Apremilast across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
13 single-substance products containing Apremilast on the HPRA medicines list.
- Apremilast Clonmel 30 mg film-coated tabletsClonmel Healthcare Ltd · PA0126/374/001 · Marketed
- Apremilast Krka 30 mg film-coated tabletsKRKA, d.d., Novo mesto · PA1347/114/002 · Marketed
- Apremilast Accord 10 mg film-coated tablets Apremilast Accord 20 mg film-coated tabletsAccord Healthcare S.L.U. · EU/1/24/1796/005
- Apremilast Accord 10 mg film-coated tablets Apremilast Accord 20 mg film-coated tablets Apremilast Accord 30 mg film-coated tabletsAccord Healthcare S.L.U. · EU/1/24/1796/001
- Apremilast Accord 20 mg film-coated tabletsAccord Healthcare S.L.U. · EU/1/24/1796/006-007
Supply shortages
No entry for Apremilast in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Apremilast
14 conditionsAll 14 conditions
| Condition (as registered) | Trials |
|---|---|
| Psoriatic Arthritis | 2 |
| Respiratory Tract Diseases | 1 |
| Influenza (Pandemic) | 1 |
| Influenza | 1 |
| Community Acquired Pneumonia | 1 |
| Behçet Disease | 1 |
| Active Juvenile Psoriatic Arthritis | 1 |
| Psoriasis | 1 |
| Recurrent Aphtous Stomatitis | 1 |
| Behçet's Disease | 1 |
| Juvenile Psoriatic Arthritis | 1 |
| Plaque Psoriasis | 1 |
| Ultrasound Assessment | 1 |
| TNF | 1 |
Sponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Amgen | 3 |
| Bristol-Myers Squibb | 3 |
| UMC Utrecht | 1 |
| University Hospital, Rouen | 1 |
| Tanta University | 1 |
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Apremilast trials
How many clinical trials are testing Apremilast?
9 current trials in our Spain, France, Italy, Germany, Belgium, Japan, Israel, UK, Turkey, Netherlands, Switzerland, Czechia, Portugal, Canada, Australia, USA, Poland, Ireland, India, China, Mexico, Taiwan and Egypt registers name Apremilast (also registered as AMG 407) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Apremilast trials recruiting patients?
Yes. 7 of the 9 trials are recruiting: 4 with sites in Spain, 4 with sites in France, 3 with sites in Italy, 2 with sites in Germany, 2 with sites in Belgium, 2 with sites in Japan, 3 with sites in Israel, 2 with sites in UK, 3 with sites in Turkey, 2 with sites in Netherlands, 2 with sites in Switzerland, 1 with sites in Czechia, 2 with sites in Portugal, 1 with sites in Canada, 1 with sites in Australia, 1 with sites in USA, 1 with sites in Poland, 1 with sites in Ireland and 1 with sites in India. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Apremilast clinical trials?
Amgen (3), Bristol-Myers Squibb (3), UMC Utrecht (1) and University Hospital, Rouen (1), among 5 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Apremilast clinical trials in Ireland?
Yes. 1 trial in our Ireland register (ClinicalTrials.gov). Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.
Is Apremilast licensed in Ireland?
Yes. The HPRA medicines list includes 13 single-substance products containing Apremilast, for example Apremilast Clonmel 30 mg film-coated tablets (Clonmel Healthcare Ltd). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Apremilast shortage?
Not in the lists we track: Apremilast has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Apremilast works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Apremilast works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Apremilast (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.