New Pill for Scarred-Lung Disease in Adults

Nintedanib and pirfenidone have been the IPF/PPF pills for more than a decade. Jascayd (nerandomilast) is a twice-daily PDE4B tablet with a different mechanism. The FDA labelled it for adults with IPF on 7 October 2025, then for adults with PPF on 19 December 2025 (FDA news). The European Commission authorised both indication lines on 15 July 2026. The UK MHRA authorised both on 8 July 2026. Japan’s MHLW approval is a company announcement dated 18 May 2026.

Health Canada accepted the NDS in December 2025. As of the SUR list dated 31 July 2026, it is still under review. That is not a no. Australia is under evaluation. NICE GID-TA11552 is in progress, not a recommendation.

IPF and PPF are two labelled conversations.

Where this is taking place

FIBRONEER-IPF (NCT05321069) — completed. Phase 3, n=1177 actual, ages ≥40. Sponsor Boehringer Ingelheim. Canada had 12 sites (historical). Not an enrolment path. NEJM: Richeldi L et al., 18 May 2025, DOI 10.1056/NEJMoa2414108.

FIBRONEER-ILD / PPF (NCT05321082) — completed. Phase 3, n=1178 actual, ages ≥18. Not an enrolment path. Eleven Canadian historical sites on CT.gov: Kelowna Respirology & Allergy Research; Vancouver General Hospital; St. Paul’s (Vancouver); Dr. Georges-L.-Dumont (Moncton); St. Joseph’s Healthcare Hamilton; Dr. Syed Anees (Windsor); CHUM; MUHC; IUCPQ; CIC Mauricie (Trois-Rivières); Royal University Hospital Saskatoon. No Edmonton, no Halifax on this ILD record. NEJM: Maher TM et al., DOI 10.1056/NEJMoa2503643.

FIBRONEER-ON (NCT06238622) — recruiting open-label extension. Who it is for: people who finished a parent FIBRONEER trial without permanently discontinuing. 13 Canadian sites listed recruiting. Not a first-access trial for untreated patients.

FIBRONEER-ACT (NCT07540988) — now recruiting (ClinicalTrials.gov status verified September 2026; checked 10 October 2026). Phase 3, fibrosing ILD other than IPF, at risk for PPF. In Canada, one site is recruiting: Kelowna Respirology & Allergy Research in Kelowna, BC. The other five listed Canadian sites (Sherwood Park, Vancouver, Toronto, Trois-Rivières and Québec City) and all 31 US sites are listed as not yet recruiting. It does not give access to the approved medicine for IPF or PPF. It is a research trial for adults with scarring lung disease other than idiopathic pulmonary fibrosis (IPF), diagnosed within the last 3 years. People who already have progressive pulmonary fibrosis (PPF), or who have taken nerandomilast, nintedanib or pirfenidone, cannot join. People are put into 2 groups by chance, and one group gets a placebo (a dummy pill). The trial team decides who can join.

FIBRONEER-chILD (NCT07366034) — recruiting, ages 2 to 17, fibrosing ILD. Not the adult IPF/PPF label.

NERAM-PF (NCT07570888) — not yet recruiting. No locations on CT.gov. IPF is an exclusion.

Commercial supply: US (Rx; USPI does not mandate specialty pharmacy or a REMS; retail vs specialty unknown from the label), EU (restricted Rx), UK (MHRA), Japan (MHLW, company date). Canada: not marketed.

Approval matrix

Access by country

• United States: Pulmonologist / ILD clinic. FDA-labelled IPF (7 Oct 2025) and PPF (19 Dec 2025, FDA news). Oral 9 mg / 18 mg tablets. The USPI does not mandate specialty pharmacy or a REMS. Retail vs specialty is unknown from the label. CareConnect4Me: JASCAYD.com or 844-JASCAYD (1-844-527-2293) — US-only. DailyMed also lists 1-800-542-6257. No copay dollars.
• United Kingdom: MHRA authorised 8 Jul 2026. NICE GID-TA11552 is in progress, not a yes. Ask the ILD clinic; do not assume NHS routine funding.
• European Union: EC MA 15 Jul 2026. Prescription; start by a doctor experienced in IPF or PPF. National reimbursement unknown. CHMP 21 May 2026 was the opinion, not the licence.
• Japan: In-country commercial after MHLW (company 18 May 2026). NHI listing unknown. Not a Canadian travel path.
• China: In-country commercial per BI, split dates. NMPA pages not retrieved. NRDL not found. Not a Canadian travel path.
• Australia: TGA under evaluation. Not ARTG. SAS theoretically exists; manufacturer supply unknown. No SAS ID is given here.
• Canada (does not change the access level shown above): No NOC, no DIN. SUR under review (accepted Dec 2025; list current 31 Jul 2026). CDA-AMC SR0941 (IPF) and SR0954 (PPF) still Pre-NOC/active (initiated 16 Jun 2026; IPF expert committee 28 Oct 2026; draft rec window Nov 2026). “Reduction in risk of death” on the PPF file is sponsor-requested, not an HC label. SAP unknown — a paperwork route because it is not marketed; manufacturer supply not found; not available and not refused. FIBRONEER-ON is completers only. FIBRONEER-ACT is now recruiting at one Canadian site, in Kelowna, BC. The other five listed Canadian sites are not yet recruiting. FIBRONEER-chILD (ages 2–17) is recruiting in other countries; its 2 Canadian sites are not yet recruiting. This Canada note is not a Compassionate Access tag.
• Switzerland: Authorisation not found. No BI named-patient programme is confirmed.

If your regulator has not authorised it: do not import on your own.

What the pivotal trials showed

The trials enrolled people with FVC ≥45% predicted; the US/EU indication lines have no % predicted FVC floor.

IPF (NCT05321069 / NEJM Richeldi 2025). 52-week FVC, NEJM: 18 mg −114.7 mL, 9 mg −138.6 mL, placebo −183.5 mL. Difference vs placebo 68.8 mL (18 mg) and 44.9 mL (9 mg). About 78% were already on nintedanib or pirfenidone. Key secondary composite not met. Diarrhea 41.3% / 31.1% / 16.0%. US PI uses a mortality-adjusted model: 18 mg −106 mL vs placebo −170 mL.

PPF (NCT05321082 / NEJM Maher). 52-week FVC, NEJM: 18 mg −98.6 mL, 9 mg −84.6 mL, placebo −165.8 mL. Differences 67.2 mL and 81.1 mL. Background nintedanib in 43.5%; pirfenidone was a trial exclusion in this study. Key secondary on the US label not statistically significant. All-cause death HR 0.51 is not multiplicity-controlled on the US PI.

This is slower decline, not a cure. 9 mg plus pirfenidone was not effective in FIBRONEER-IPF — stay at 18 mg if you are on pirfenidone.

How it is taken (labelled)

18 mg twice daily, about 12 hours apart, with or without food. Swallow whole or disperse in ~100 mL still water. Reduce to 9 mg BID if 18 mg is not tolerated — except with pirfenidone or moderate CYP3A inducers (stay at 18 mg). Strong CYP3A inhibitors → 9 mg BID. Avoid strong CYP3A inducers (US).

Add-on: IPF trials allowed nintedanib or pirfenidone. PPF trial allowed nintedanib or none. Diarrhea is more common with nintedanib combination.

US: no contraindications listed. EU: hypersensitivity. Pregnancy: animal fetal-loss signal; EU “not recommended in pregnancy.” Not established in children. Not recommended in eGFR <15 or Child-Pugh C.

Research team (Who)

Names as they appear on primary sources.

• Luca Richeldi — first author, FIBRONEER-IPF NEJM.
• Toby M. Maher — first author, FIBRONEER-ILD NEJM.
• Boehringer Ingelheim — sponsor (FIBRONEER family). US/EU/UK/JP MAH family. Canada applicant: Boehringer Ingelheim (Canada) Ltd.

Canadian parent-trial sites are historical. OLE sites on CT.gov are for completers, not a clinic directory.

How to talk to a doctor

1. Do I have IPF or PPF? The labels split them.
2. Am I on nintedanib or pirfenidone? If pirfenidone, stay at 18 mg.
3. Pregnancy, contraception, breastfeeding.
4. Strong CYP3A inhibitors/inducers; kidney or severe liver disease.
5. Canada: no DIN. Wait for NOC, ask about SAP (supply unknown), or OLE only if I finished a parent trial. FIBRONEER-ACT is now recruiting in Kelowna, BC. It is only for scarring lung disease other than IPF that does not yet count as PPF, in people who have not taken nerandomilast, nintedanib or pirfenidone. One of its 2 groups gets a placebo. Could I fit? Do not mail-order.
6. US: prescription; USPI does not mandate specialty pharmacy. Channel unknown from the label. Ask the clinic about CareConnect4Me (844-JASCAYD) — US-only. No copay dollar here.
7. UK: MHRA yes, NICE GID-TA11552 in progress, not a yes.

Canada close-up: under review / SAP unknown

Health Canada is under review. SAP is the paperwork route for a non-marketed drug; manufacturer supply unknown. This Canada note does not change the access level shown above. US/EU/UK: labelled commercial paths. Japan: company MHLW announcement (18 May 2026), not independently labelled. FIBRONEER-ON is completers only. FIBRONEER-ACT is now recruiting at one Canadian site (Kelowna, BC). The other five listed Canadian sites are not yet recruiting. FIBRONEER-chILD (ages 2–17) is recruiting in other countries; its 2 Canadian sites are not yet recruiting. FVC ≥45% is trial / CDA-sponsor language, not labelled.

Bottom line

Nerandomilast is labelled for adults with IPF and adults with PPF in the United States, the European Union, the United Kingdom, and — on a company MHLW announcement — Japan. China’s NMPA dates stay company until nmpa.gov.cn. Health Canada is under review, not refused. TGA is under evaluation. NICE is in progress, not a yes. The US label does not mandate specialty pharmacy. In Canada, no trial offers a first prescription of the labelled medicine. The open-label extension is only for people who finished an earlier trial. FIBRONEER-ACT is recruiting in Kelowna, BC, but only for scarring lung disease other than idiopathic pulmonary fibrosis that does not yet count as progressive pulmonary fibrosis, in people who have not taken nerandomilast, nintedanib or pirfenidone. It compares the medicine with a placebo. FIBRONEER-chILD is for ages 2 to 17, and its sites are not named here. Canada is covered separately above.

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Primary sources

1. FDA IPF bulletin, 7 Oct 2025 — https://content.govdelivery.com/accounts/USFDA/bulletins/3f61959
2. NDA 218764 ORIG-1 letter — https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218764Orig1s000ltr.pdf
3. DailyMed JASCAYD (PPF 12/2025; no specialty-pharmacy mandate; also 1-800-542-6257) — https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=fa1b14c6-957f-d326-5099-911bfe33e391 3a. FDA PPF news, 19 Dec 2025 — https://content.govdelivery.com/accounts/USFDA/bulletins/401121a
4. EMA EPAR Jascayd (CHMP 21 May 2026; EC 15 Jul 2026) — https://www.ema.europa.eu/en/medicines/human/EPAR/jascayd
5. EMA SmPC — https://www.ema.europa.eu/en/documents/product-information/jascayd-epar-product-information_en.pdf
6. GOV.UK MHRA, 8 Jul 2026 — https://www.gov.uk/government/news/nerandomilast-jascayd-approved-to-treat-adult-patients-with-idiopathic-pulmonary-fibrosis-and-progressive-pulmonary-fibrosis
7. NICE GID-TA11552 in progress — https://www.nice.org.uk/guidance/indevelopment/gid-ta11552
8. Health Canada SUR (current as of 2026-07-31) — https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/submissions-under-review/new-drug-submissions-under-review.html
9. CDA-AMC SR0941-000 IPF Pre-NOC — https://www.cda-amc.ca/nerandomilast
10. CDA-AMC SR0954-000 PPF Pre-NOC — https://www.cda-amc.ca/nerandomilast-0
11. TGA under evaluation — https://www.tga.gov.au/resources/prescription-medicines-under-evaluation/tradename-boehringer-ingelheim-pty-ltd
12. NCT05321069 FIBRONEER-IPF COMPLETED — https://clinicaltrials.gov/study/NCT05321069
13. NCT05321082 FIBRONEER-ILD COMPLETED — https://clinicaltrials.gov/study/NCT05321082
14. NCT06238622 FIBRONEER-ON RECRUITING, completers only — https://clinicaltrials.gov/study/NCT06238622
15. NCT07540988 FIBRONEER-ACT, recruiting (verified 2026-09; recruiting Canadian site: Kelowna, BC) — https://clinicaltrials.gov/study/NCT07540988
16. NCT07366034 FIBRONEER-chILD recruiting 2–17 — https://clinicaltrials.gov/study/NCT07366034
17. NCT07570888 NERAM-PF NYR, no CT.gov sites; IPF exclusion — https://clinicaltrials.gov/study/NCT07570888
18. Richeldi L et al. NEJM. DOI 10.1056/NEJMoa2414108 — https://www.nejm.org/doi/full/10.1056/NEJMoa2414108
19. Maher TM et al. NEJM. DOI 10.1056/NEJMoa2503643 — https://www.nejm.org/doi/full/10.1056/NEJMoa2503643
20. BI Japan MHLW announcement 18 May 2026 (company) — https://www.globenewswire.com/news-release/2026/05/18/3296295/0/en/JASCAYD-nerandomilast-approved-in-Japan-advancing-global-access-to-a-new-IPF-and-PPF-treatment.html
21. BI NMPA IPF: company announcement 22 Oct 2025; official approval date from China's drug regulator, the NMPA, not confirmed — https://www.biospace.com/press-releases/jascayd-nerandomilast-approved-in-china-for-the-treatment-of-idiopathic-pulmonary-fibrosis-ipf
22. BI NMPA PPF 10 Dec 2025 (company, until nmpa.gov.cn) — https://www.globenewswire.com/fr/news-release/2025/12/10/3202994/0/en/JASCAYD-nerandomilast-receives-first-regulatory-approval-for-progressive-pulmonary-fibrosis-in-china.html
23. CareConnect4Me 844-JASCAYD (US only; no copay dollars) — JASCAYD.com