Name: Zipalertinib (CLN-081) in EGFR exon 20 insertion-mutated non-small-cell lung cancer: Phase of product development
Published: 2026-09-14T15:39:06-04:00

Product information and disease description Product description

Phase of product development

8 evidence topics · 6 sources

Regulatory status

“Zipalertinib is investigational and has not been approved by any health authority.” (opens the source at this quote in a new tab)

FDA submission initiation

“Nov. 20, 2025” (opens the source at this quote in a new tab)
“the companies have initiated the rolling submission of a New Drug Application (NDA)” (opens the source at this quote in a new tab)

Regulatory submission: NDA submitted February 2026

“In February 2026” (opens the source at this quote in a new tab)
“Taiho completed a rolling submission of a new drug application (“NDA”) seeking accelerated approval of zipalertinib” (opens the source at this quote in a new tab)

FDA acceptance date

“April 28, 2026” (opens the source at this quote in a new tab)

FDA acceptance

“has accepted a New Drug Application (NDA) for zipalertinib” (opens the source at this quote in a new tab)

Anticipated FDA action date

“PDUFA target action date of February 27, 2027” (opens the source at this quote in a new tab)

Special FDA designation: initial announcement

“has granted Breakthrough Therapy Designation for CLN-081” (opens the source at this quote in a new tab)

Special FDA designation: later historical description

“Zipalertinib previously received Breakthrough Therapy Designation in 2021” (opens the source at this quote in a new tab)

Launch

No evidence found.

Product launch date and FDA Advisory Committee meeting

No evidence found.