Drugs / XS003
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT07138352 | Oct 2024 → Jan 2025 | cancer | Xspray Pharma AB | Completed | No outcome recorded |
| Phase 1 | NCT02068898 | Dec 2013 → Mar 2014 | — | XSpray Microparticles | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2026-09-23 | Xspray Pharma AB | Results Xspray Pharma to present CML data supporting differentiation of Dasynoc and Nilopki xspraypharma.com ↗
The data indicate that Nilopki avoids the food-induced increase in plasma exposure seen with crystalline nilotinib. |
| 2026-04-14 | Xspray Pharma AB | Regulatory FDA accepts trade name Nilopki® for Xspray’s drug candidate XS003 (nilotinib) xspraypharma.com ↗
The US Food and Drug Administration (FDA) has accepted Nilopki® as the proprietary name for Xspray Pharma's drug candidate XS003 (nilotinib). |
| 2025-10-21 | Xspray Pharma AB | Regulatory Xspray Pharma: FDA accepts New Drug Application for XS003 (nilotinib) for the treatment of CML – PDUFA date set for June 18, 2026 xspraypharma.com ↗
Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY) announces that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for XS003 (nilotinib) for review under the 505(b)(2) regulatory pathway. |
| 2025-08-19 | Xspray Pharma AB | Regulatory Xspray Pharma Submits XS003 to the FDA – The Company’s Second Product Candidate from the HyNap Platform xspraypharma.com ↗
Xspray Pharma (Nasdaq Stockholm: XSPRAY) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its product candidate XS003 (nilotinib) for the treatment of chronic myeloid leukemia (CML). |
| 2025-07-11 | Xspray Pharma AB | Results XSpray Pharma achieves significant milestone – demonstrating bioequivalence with absorption advantages compared to Tasigna xspraypharma.com ↗
The results confirm formal bioequivalence between XS003 and Tasigna in terms of systemic exposure (AUC and Cmax) – despite the XS003 dose being less than half that of the reference drug. |
| 2025-01-20 | Xspray Pharma AB | Results Xspray Pharma reports strong interim data for product candidate XS003 – confirms plan to apply for market approval in H1 2025 xspraypharma.com ↗
Xspray Pharma AB (publ) today presents interim data from a food interaction study with the nilotinib product candidate (XS003). |
| 2024-07-09 | Xspray Pharma AB | Results Xspray Pharma’s XS003 Study shows Matching Bioavailability to Tasigna at more than a 50% Lower Dose xspraypharma.com ↗
In the announced study, XS003 demonstrates matching bioavailability to Tasigna, with a 50% reduced dose. |
| 2023-11-21 | Xspray Pharma AB | Results Xspray Pharma’s XS003 Achieves Superior Bioavailability Milestone, Matching TASIGNA® at Reduced Dosage xspraypharma.com ↗
today announced that XS003, its amorphous, non-crystalline formulation of nilotinib, has demonstrated bioavailability within the 80-125% range to TASIGNA® following oral administration with significantly lower dose. |
All press releases naming this drug 8 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | XS003 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02068898 ↗ |
| Known as | nilotinib | “This is a single-dose, open-label, randomized, crossover study to evaluate the comparative oral bioavailability of XS003 (nilotinib) Capsules 192 mg (4X 48 mg) of Xspray Pharma...” NCT07138352 ↗ |
| Route | Oral | “XS003 given as a single oral dose” NCT02068898 ↗ |