Pulmonology

Idiopathic pulmonary fibrosis (IPF): 2 drugs compared for prescribers

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Esbriet, Jascayd side by side on what each first fill waits on, what the label requires you to monitor and what an insurer asks to see, with FDA decisions, label changes and open trials for idiopathic pulmonary fibrosis (IPF). One other FDA-approved medicine for idiopathic pulmonary fibrosis has no prescribing guide here yet and is listed below.

When to suspect idiopathic pulmonary fibrosis (IPF) and what to test →

2prescribing guides ↓1other approved medicine, no guide yet ↓1FDA decision pending ↓106recruiting or not yet recruiting ↓

November 9, 2026last checked

Studies patients can follow

PureTech's phase 3 deupirfenidone study (NCT07284602). Patients can follow it for site openings and print a pre-check summary written for their pulmonologist.

The 2 idiopathic pulmonary fibrosis (IPF) prescribing guides

One page per drug with the dispensing gate, prior authorization documentation, dosing, monitoring and interactions, each line sourced.

Esbriet (pirfenidone)Liver Tests, Titration, CYP1A2 and PA CriteriaNo REMS; baseline ALT, AST and bilirubin before the first dose, a CYP1A2 medication review, smoking counseling, and prior authorization, which for brand Esbriet often means generic pirfenidone first.Open the Esbriet prescribing guide →

Patient guide · Printable handout · Drug page

Jascayd (nerandomilast)Dosing With Pirfenidone, Monitoring, PANo REMS; a medication review for pirfenidone, nintedanib and CYP3A inhibitors or inducers, the Prescription and Patient Support Program Enrollment Form through CoverMyMeds or fax, and prior authorization.Open the Jascayd prescribing guide →

Patient guide · Printable handout · Drug page

The 2 drugs with a prescribing guide, side by side

Each cell is a summary of that drug's prescribing guide, which carries the full detail and a source on every line. Insurer thresholds are one public policy shown as an example; plans differ.

	Esbrietpirfenidone	Jascaydnerandomilast
Label dated	June 9, 2025	August 14, 2026
Starting dose	267mg three times daily (801mg a day), with food at the same times each day.	18mg twice daily, approximately 12 hours apart, with or without food; no titration. Maximum 18mg twice daily. A 60-tablet bottle is a 30-day supply.
Dispensing gate	No REMS; baseline ALT, AST and bilirubin before the first dose, a CYP1A2 medication review, smoking counseling, and prior authorization, which for brand Esbriet often means generic pirfenidone first	No REMS; a medication review for pirfenidone, nintedanib and CYP3A inhibitors or inducers, the Prescription and Patient Support Program Enrollment Form through CoverMyMeds or fax, and prior authorization
Required monitoring	ALT, AST and bilirubin at baseline, monthly for 6 months, then every 3 months and as clinically indicated; prompt testing for liver symptoms; skin and GI effects most frequent early	No required laboratory monitoring; diarrhea mostly in the first 3 months and most frequent with nintedanib, weight and appetite, mood, and pregnancy
Example PA threshold	Cigna example: age 18 or older, FVC at least 40% predicted at baseline, UIP on HRCT or surgical biopsy, pulmonologist, generic tried first for brand, not with nintedanib	FEP example: age 18 or older, %FVC or %DLCO 90% predicted or lower, FEV1/FVC 70% or higher, definite or probable UIP on HRCT, no known cause, pulmonologist, drug interaction assessment
Support line	Legacy Pharma, Legacy Patient Program specialists 1-866-435-8080 (enrollment fax 1-855-973-2775), Esbriet Co-pay Program to as little as $5 per 30-day supply up to $25,000 a year for commercial plans, free drug for eligible uninsured, uncovered or high out-of-pocket patients	CareConnect4Me, 1-844-527-2293, enrollment fax 1-866-725-7218 (CoverMyMeds), copay as little as $0 for commercial plans, Bridge Program free 30-day supply plus 1 refill during payer delays, BI Cares Foundation free drug for eligible uninsured or underinsured

Esbriet pirfenidone

Label dated: June 9, 2025
Starting dose: 267mg three times daily (801mg a day), with food at the same times each day.
Dispensing gate: No REMS; baseline ALT, AST and bilirubin before the first dose, a CYP1A2 medication review, smoking counseling, and prior authorization, which for brand Esbriet often means generic pirfenidone first
Required monitoring: ALT, AST and bilirubin at baseline, monthly for 6 months, then every 3 months and as clinically indicated; prompt testing for liver symptoms; skin and GI effects most frequent early
Example PA threshold: Cigna example: age 18 or older, FVC at least 40% predicted at baseline, UIP on HRCT or surgical biopsy, pulmonologist, generic tried first for brand, not with nintedanib
Support line: Legacy Pharma, Legacy Patient Program specialists 1-866-435-8080 (enrollment fax 1-855-973-2775), Esbriet Co-pay Program to as little as $5 per 30-day supply up to $25,000 a year for commercial plans, free drug for eligible uninsured, uncovered or high out-of-pocket patients

Jascayd nerandomilast

Label dated: August 14, 2026
Starting dose: 18mg twice daily, approximately 12 hours apart, with or without food; no titration. Maximum 18mg twice daily. A 60-tablet bottle is a 30-day supply.
Dispensing gate: No REMS; a medication review for pirfenidone, nintedanib and CYP3A inhibitors or inducers, the Prescription and Patient Support Program Enrollment Form through CoverMyMeds or fax, and prior authorization
Required monitoring: No required laboratory monitoring; diarrhea mostly in the first 3 months and most frequent with nintedanib, weight and appetite, mood, and pregnancy
Example PA threshold: FEP example: age 18 or older, %FVC or %DLCO 90% predicted or lower, FEV1/FVC 70% or higher, definite or probable UIP on HRCT, no known cause, pulmonologist, drug interaction assessment
Support line: CareConnect4Me, 1-844-527-2293, enrollment fax 1-866-725-7218 (CoverMyMeds), copay as little as $0 for commercial plans, Bridge Program free 30-day supply plus 1 refill during payer delays, BI Cares Foundation free drug for eligible uninsured or underinsured

Other FDA-approved medicines for idiopathic pulmonary fibrosis

These have no Trial Friend prescribing guide yet, so they are not in the comparison above. Some are approved for a different form or use of the condition than the guides above, and each drug page gives its indication. The list comes from Trial Friend's audited list of FDA labels that name this condition, built October 21, 2026.

OfevNintedanibBoehringer Ingelheim (generics from several makers since 2026)

FDA decisions for idiopathic pulmonary fibrosis (IPF)

From the Trial Friend FDA decision calendar, which records each date from the sponsor's or the FDA's own announcement.

Late April 2027Tyvaso (nebulized treprostinil), sNDA, United TherapeuticsPending

Recent label changes

What changed in each label revision, from the FDA's approval letters and the labels' own revision lists.

August 2026Jascayd. The dose rule for moderate CYP3A inducers changed after 2 drug interaction trials. The February 2026 label said to avoid moderate and strong inducers alike. The new label keeps 18mg twice a day with a moderate inducer and still says to avoid strong ones. FDA letter
February 2026Jascayd. The IPF labeling was harmonized with the progressive pulmonary fibrosis application, in the FDA letter's words. That separate application had been approved by the FDA on December 19, 2025. FDA letter
December 2025Jascayd. Progressive pulmonary fibrosis was approved as a second use, under a separate FDA application that was then folded into the main one. FDA letter
October 2025Jascayd. Jascayd was first approved for idiopathic pulmonary fibrosis in adults. The FDA asked Boehringer for further trials of how pirfenidone and CYP3A inducers change nerandomilast levels. FDA letter
June 2025Esbriet. Legacy Pharma published its own Esbriet label after taking over the brand. It lists only the 267mg and 801mg tablets, in bottles of 270 and 90, and gives Legacy Pharma's side effect line, 1-800-727-7151. The dosing, warnings and interaction sections match the February 2023 text. FDA label
February 2023Esbriet. Severe skin reactions were added to the warnings after an FDA safety notice. The label names Stevens-Johnson syndrome, toxic epidermal necrolysis and DRESS among them. The label says to pause Esbriet if one is suspected and stop for good if one is confirmed. FDA letter
February 2022Esbriet. This was a change to the side effects table only. The term anorexia was dropped and its cases were counted under decreased appetite. FDA letter
July 2019Esbriet. The FDA required new labeling on the risk of drug-induced liver injury, following a safety notice it sent to Genentech. The approval letter does not spell out which sentences changed. FDA letter

Open trials

106

studies listing Idiopathic Pulmonary Fibrosis are recruiting or not yet recruiting on ClinicalTrials.gov

Counted live, at most once a day

Screen a patient against them

Questions prescribers ask about Idiopathic pulmonary fibrosis (IPF)

Which Idiopathic pulmonary fibrosis (IPF) drugs require a REMS?

This answer covers Esbriet and Jascayd, the drugs with a prescribing guide here, and not the 1 other approved medicine listed on this page. None of the 2 Idiopathic pulmonary fibrosis (IPF) drugs on this page has a REMS: Esbriet and Jascayd. Each prescribing guide lists what does gate the first fill.

What monitoring do Idiopathic pulmonary fibrosis (IPF) drugs require?

This answer covers Esbriet and Jascayd, the drugs with a prescribing guide here, and not the 1 other approved medicine listed on this page. Esbriet: ALT, AST and bilirubin at baseline, monthly for 6 months, then every 3 months and as clinically indicated; prompt testing for liver symptoms; skin and GI effects most frequent early. Jascayd: No required laboratory monitoring; diarrhea mostly in the first 3 months and most frequent with nintedanib, weight and appetite, mood, and pregnancy.

What do insurers require before covering Esbriet and Jascayd?

Each answer below is one public insurer policy, an example rather than every plan. Esbriet: Cigna example: age 18 or older, FVC at least 40% predicted at baseline, UIP on HRCT or surgical biopsy, pulmonologist, generic tried first for brand, not with nintedanib. Jascayd: FEP example: age 18 or older, %FVC or %DLCO 90% predicted or lower, FEV1/FVC 70% or higher, definite or probable UIP on HRCT, no known cause, pulmonologist, drug interaction assessment.

Which support programs start Idiopathic pulmonary fibrosis (IPF) patients on therapy?

This answer covers Esbriet and Jascayd, the drugs with a prescribing guide here, and not the 1 other approved medicine listed on this page. Esbriet: Legacy Pharma, Legacy Patient Program specialists 1-866-435-8080 (enrollment fax 1-855-973-2775), Esbriet Co-pay Program to as little as $5 per 30-day supply up to $25,000 a year for commercial plans, free drug for eligible uninsured, uncovered or high out-of-pocket patients. Jascayd: CareConnect4Me, 1-844-527-2293, enrollment fax 1-866-725-7218 (CoverMyMeds), copay as little as $0 for commercial plans, Bridge Program free 30-day supply plus 1 refill during payer delays, BI Cares Foundation free drug for eligible uninsured or underinsured.

A reference for licensed professionals, checked on November 9, 2026. Labels and plan policies change; the label on DailyMed and the plan's current policy govern. Not medical advice. For patients: the Idiopathic pulmonary fibrosis (IPF) page and the first 90 days pages for Esbriet, Jascayd.