Nerandomilast
JASCAYD
What it isPreferential PDE4B inhibitor; idiopathic pulmonary fibrosis and progressive pulmonary fibrosis.
Why this oneIt is the first new IPF mechanism since the two antifibrotics, slowing lung-function decline with a tolerability profile gentler than nonselective PDE4 inhibition.
What limits itDiarrhea, nausea, appetite loss, and weight loss can end treatment; therapy slows decline rather than restoring lung.
FDA-approved for
- idiopathic pulmonary fibrosis (2025)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Idiopathic pulmonary fibrosis (IPF) | Adults | 18 mg BID (~12 h apart) | 18 mg BID | 18 mg BID |
| Progressive pulmonary fibrosis (PPF) | Adults | 18 mg BID (~12 h apart) | 18 mg BID | 18 mg BID |
Renal Mild–severe (eGFR >=15): no adjustment; not recommended in ESRD (eGFR <15)
Hepatic Child-Pugh A/B: no adjustment; not recommended in Child-Pugh C
With strong CYP3A inhibitors: reduce to 9 mg BID (no change for moderate/weak)
Instructions
- With or without food; swallow whole, or disperse in ~100 mL room-temp non-carbonated water (stir ~15–20 min; drink within 2 h; rinse glass with ~100 mL water and drink)
- If 18 mg BID not tolerated, reduce to 9 mg BID — EXCEPT with concomitant pirfenidone (keep 18 mg BID; do not reduce)
- Missed dose: skip; take next dose at scheduled time
Cautions
- Diarrhea — most common reaction and top cause of discontinuation; worst with concomitant nintedanib (up to 62%)
- Depression (incl. suicidal ideation) reported in trials (12% vs 10% placebo)
- Weight decrease and decreased appetite, esp. with concomitant nintedanib
Adverse reactions
- Diarrhea (42% at 18 mg BID)
- COVID-19
- URTI
- Depression (incl. suicidal ideation)
- Weight decreased
- Decreased appetite
- Nausea
- Fatigue
- Headache
- Vomiting
- Back pain
- Dizziness (all >=5%)
Pregnancy No human data; animal studies: embryo-fetal loss at ~5× MRHD — may increase risk of fetal loss.
Lactation No human data; present in animal milk; weigh benefit vs risk.
NO BOXED WARNINGS
Classes and tags
Clinical profile
Mechanism of action: Nerandomilast ballicule
