Roflumilast is named as an intervention in 2 current clinical trials in our USA and China registers. 1 is recruiting patients now. The most common phase is Phase 4. The sponsor with the most trials is Integrative Skin Science and Research (1). The most-studied condition is ITCH.
| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
Obtaining Descriptive Classifications of Pruritus and Assessing Change in Pruritus Over Time in Atopic Dermatitis Patients Using Topical Roflumilast Cream.
NCT07560618 · ClinicalTrials.gov ↗ · ITCH, Atopic Dermatitis
|
Phase 4 | Recruiting | Integrative Skin Science and Research | USA |
|
A Study to Investigate the Biomarkers of Hemay005 in Adult Participants With Moderate to Severe COPD
NCT07314242 · ClinicalTrials.gov ↗ · COPD (Chronic Obstructive Pulmonary Disease)
|
Phase 2 | Not yet open | Ganzhou Hemay Pharmaceutical Co., Ltd | China |
Registers 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.
The same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
2 single-substance products containing Roflumilast on the HPRA medicines list.
No entry for Roflumilast in the EMA, FDA or German BfArM shortage lists we track.
| Lead sponsor | Trials |
|---|---|
| Integrative Skin Science and Research | 1 |
| Ganzhou Hemay Pharmaceutical Co., Ltd | 1 |
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in USA | 1 | 1 |
| Clinical trials in China | 1 | 0 |
A trial with sites in more than one country appears in each of those registers.
2 current trials in our USA and China registers name Roflumilast as a drug or biological intervention, as of the registry sync on 26 September 2026. Completed and withdrawn studies are not counted.
Yes. 1 of the 2 trials is recruiting: 1 with sites in USA. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Integrative Skin Science and Research (1) and Ganzhou Hemay Pharmaceutical Co., Ltd (1). The number in brackets is how many trials each organisation leads.
Yes. The HPRA medicines list includes 2 single-substance products containing Roflumilast, for example Daxas 250 micrograms tablets (AstraZeneca AB). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Not in the lists we track: Roflumilast has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Roflumilast works or whether it is effective, and it is not medical advice.
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Roflumilast works or whether it is effective. Each trial links to its own record so you can check it yourself.
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Roflumilast (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 26 Sep 2026.