Nerandomilast clinical trials
Nerandomilast is named as an intervention in 7 current clinical trials in our UK, USA, Germany, France, Spain, Italy, Netherlands, Japan, South Korea, Australia, China, Belgium, Canada, Mexico, Poland, Brazil, Austria, Czechia, Portugal, Taiwan, Denmark, Switzerland, Norway, Israel, Ireland, India, Sweden, Turkey and Singapore registers. 4 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Boehringer Ingelheim (6). The most-studied condition is Interstitial Lung Diseases. The EU clinical trials register (CTIS) separately lists 3 authorised or ongoing trials.
Where Nerandomilast is approved
All regulators →Of the three regulators tracked here, the first to approve Nerandomilast was the US, on 7 Oct 2025. It is approved in 3 of the 3 regulators tracked here.
- 1 EU orphan designation, most recently for treatment of idiopathic pulmonary fibrosis (28 Jun 2024, withdrawn)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.
Nerandomilast patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Nerandomilast, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 5 listed patents; the last listed expires 22 Oct 2038 (US 11813266).
- Latest patent on the drug substance itself: 23 Aug 2032 (US 8609670).
- Exclusivity ODE-546: Orphan drug exclusivity: treatment of idiopathic pulmonary fibrosis (ipf) in adult patients, until 7 Oct 2032.
- Exclusivity NCE: New chemical entity, until 7 Oct 2030.
- Exclusivity I-979: New indication: treatment of progressive pulmonary fibrosis (ppf) in adult patients, until 19 Dec 2028.
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 Nerandomilast
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 Nerandomilast works
All drug targets →- Interstitial lung diseasePhase 3
- Systemic sclerosisPhase 3
- Amyotrophic lateral sclerosisPhase 2/3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL5314532, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 12518, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Nerandomilast
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 2 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: JascaydEMA 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.
Trials by status
Trials by phase
Clinical trials of Nerandomilast
7 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.
Nerandomilast in the EU trials register (CTIS)
3 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Nerandomilast. 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.
Nerandomilast 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)
2 single-substance products containing Nerandomilast on the HPRA medicines list.
- Jascayd 18 mg film-coated tabletsBoehringer Ingelheim International GmbH · EU/1/26/2040/006-010
- Jascayd 9 mg film-coated tabletsBoehringer Ingelheim International GmbH · EU/1/26/2040/001-005
Supply shortages
No entry for Nerandomilast in the EMA, FDA or German BfArM shortage lists we track.
Recent approvals
- JascaydEMA · 15 Jul 2026 · Boehringer Ingelheim International GmbH
Conditions studied with Nerandomilast
9 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Boehringer Ingelheim | 6 |
| Avraham Unterman | 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 Nerandomilast trials
How many clinical trials are testing Nerandomilast?
7 current trials in our UK, USA, Germany, France, Spain, Italy, Netherlands, Japan, South Korea, Australia, China, Belgium, Canada, Mexico, Poland, Brazil, Austria, Czechia, Portugal, Taiwan, Denmark, Switzerland, Norway, Israel, Ireland, India, Sweden, Turkey and Singapore registers name Nerandomilast (also registered as BI 1015550) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Nerandomilast trials recruiting patients?
Yes. 4 of the 7 trials are recruiting: 3 with sites in UK, 3 with sites in USA, 3 with sites in Germany, 3 with sites in France, 3 with sites in Spain, 3 with sites in Italy, 3 with sites in Netherlands, 3 with sites in Japan, 3 with sites in South Korea, 3 with sites in Australia, 2 with sites in China, 3 with sites in Belgium, 3 with sites in Canada, 2 with sites in Mexico, 2 with sites in Poland, 2 with sites in Brazil, 1 with sites in Austria, 1 with sites in Czechia, 1 with sites in Portugal, 1 with sites in Taiwan, 1 with sites in Denmark and 1 with sites in Israel. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Nerandomilast clinical trials?
Boehringer Ingelheim (6) and Avraham Unterman (1). The number in brackets is how many trials each organisation leads.
Are there Nerandomilast 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 Nerandomilast licensed in Ireland?
Yes. The HPRA medicines list includes 2 single-substance products containing Nerandomilast, for example Jascayd 18 mg film-coated tablets (Boehringer Ingelheim International GmbH). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Nerandomilast shortage?
Not in the lists we track: Nerandomilast 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 Nerandomilast 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 Nerandomilast 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 Nerandomilast (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 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.