MannKind Reports Positive Inhaled Nintedanib Results
MannKind's Phase 1b INFLO-1 study of an inhaled nintedanib for idiopathic pulmonary fibrosis reported no serious adverse events.
Updated on Nov. 3, 2026 in Asthma
MannKind Corp. announced positive results from its Phase 1b study within the INFLO-1 clinical trial, which evaluates nintedanib dry powder inhalation for idiopathic pulmonary fibrosis (IPF). Patients in the study showed no drug-related diarrhea, nausea, or vomiting, no serious adverse events, and no discontinuations.
Why it matters
Roughly three out of four IPF patients are not receiving an approved antifibrotic therapy, often because the oral form of nintedanib is hard to tolerate. An inhaled version is designed to deliver the drug directly to the lungs while limiting exposure to the rest of the body.
The Phase 1b study reported no serious adverse events and no discontinuations, while efficacy results were not included in the source. Enrollment in the global Phase 2 INFLO-2 study is ongoing, so the drug's effectiveness remains unconfirmed.
The players
MannKind Corp.
MannKind is a biopharmaceutical company founded in 1991 by Alfred Mann that develops inhalation-based therapies and is headquartered in Danbury, Connecticut.
The details
The inhaled nintedanib is delivered using MannKind's Dreamboat dry powder inhaler and Technosphere formulation technology, which is also behind the FDA-approved products Afrezza and Tyvaso DPI. The Global Phase 2 INFLO-2 study is enrolling IPF patients at sites worldwide, with a 12-week controlled period followed by a 24-week extension.
Timeline
Published November 3, 2026: MannKind announces positive Phase 1b INFLO-1 results.
INFLO-2 patient follow-up runs for approximately nine months to generate safety and efficacy data.
Health Landscape
MannKind's Technosphere platform already supports two FDA-approved inhaled products, Afrezza and Tyvaso DPI, and this nintedanib program extends that approach into idiopathic pulmonary fibrosis. Applying inhalation delivery to an antifibrotic that is poorly tolerated orally could address a treatment gap for the roughly three in four IPF patients not on approved therapy.
Patients with IPF who cannot tolerate oral nintedanib may one day have an inhaled option that targets the lungs directly. The Phase 1b results do not yet establish whether the inhaled form is effective, so no change in current treatment is indicated.
The takeaway
Inhaled delivery may reduce whole-body side effects for drugs that are hard to tolerate orally, but patients should await efficacy data from the ongoing INFLO-2 study before expecting a new option.
Further reading
Explore more on Asthma to see how inhaled drug delivery is used in other chronic respiratory conditions.
Source note: This article includes information reported by Westfair Communications.
