Nerandomilast

JASCAYD

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Pronunciation: ner-an-DOE-mi-last (JAS-kayd)

Nerandomilast ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Nerandomilast ballicule

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.

Nerandomilast molecular structure (skeletal formula) — Molecular structure: Nerandomilast

FDA-approved for

idiopathic pulmonary fibrosis (2025)

FDA label

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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

Available strengths

tab 9, 18 mg

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.

Cost

Nerandomilast (JASCAYD)

Strength		#/mo	generic $/mo	CostPlus
9 mg	tab	60 BID		not offered
18 mg	tab	60 BID		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Nerandomilast is dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

NO BOXED WARNINGS

Classes and tags

Clinical profile

Therapeutic safety burden1 / 4

Overdose danger1 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk2 / 4

Legacy pregnancy categoryN/A (post-2015 labeling)

Defining liabilityDiarrhea, reduced appetite and weight loss

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