Education
About Us
Working with TipRanks
Follow Us
Xspray Pharma AB (SE:XSPRAY)
:XSPRAY
XS003 under fed and fasted condition
Cancer
Phase I
Completed
Bioavailability Study of XS003 (Nilotinib)
Jul 29, 2025
―
XS003 (nilotinib), Tasigna (nilotinib)
Cancer
Phase I
Completed
A Bioavailability Study of Nilotinib in Healthy, Adult, Human Subjects Under Fasted Conditions.
Jul 29, 2025
―
Sprycel® (Dasatinib) 100 Mg Film-Coated Tablets In Combination With Omeprazole Delayed-Release Capsules Usp, 40 Mg
Drug-Drug Interaction Study
Phase I
Completed
An Drug-drug Interaction Study to Evaluate the Effects of Omeprazole 40mg on the Pharmacokinetics of SPRYCEL®
Nov 10, 2023
―
Sorafenib - Period 1, Xs005 Sorafenib Capsule A - Period 1, Xs005 Sorafenib Tablet A - Period 1, Xs005 Sorafenib Capsule A - Period 2, Xs005 Sorafenib Tablet A - Period 2, Sorafenib - Period 2, Xs005 Sorafenib Tablet A - Period 3, Sorafenib - Period 3, Xs005 Sorafenib Capsule A - Period 3
Pharmacokinetics, Bioavailability
Phase I
Completed
Evaluating the Pharmacokinetic Parameters and Relative Bioavailability of Sorafenib (XS005) in Healthy Male Subjects
Jun 26, 2023
―
Omeprazole 40 Mg, Dasatinib Asd
Pharmacokinetics, Drug Interactions
Phase I
Completed
Evaluating the Effects of Omeprazole on the Pharmacokinetics of XS004 (Dasatinib) Tablets in Healthy Adult Subjects Under Fasting Conditions
Jun 21, 2022
―
Dasatinib Asd 100 Mg, Dasatinib 140 Mg [Sprycel]
Biological Availability
Phase I
Completed
Comparative Bioavailability of XS004 (Dasatinib) Formulation G and SPRYCEL® (Dasatinib) in Healthy, Adult Subjects Under Fasting Conditions
Jun 21, 2022
―
FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Xspray Pharma AB (XSPRAY) have in its pipeline
XSPRAY is currently developing the following drugs: XS003 under fed and fasted condition, XS003 (nilotinib), Tasigna (nilotinib), Sprycel® (Dasatinib) 100 Mg Film-Coated Tablets In Combination With Omeprazole Delayed-Release Capsules Usp, 40 Mg. These drug candidates are in various stages of clinical development as the company works toward FDA approval.