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Details:
Zeposia (ozanimod) is an oral, sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5. It is being evaluated for the treatment of Crohn’s disease.
Lead Product(s): Ozanimod
Therapeutic Area: Gastroenterology Product Name: Zeposia
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 28, 2024
Details:
Zeposia (ozanimod) is an oral, sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5. It is indicated for the treatment of relapsing forms of multiple sclerosis.
Lead Product(s): Ozanimod
Therapeutic Area: Neurology Product Name: Zeposia
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Bristol Myers Squibb
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 29, 2024
Details:
Zeposia (ozanimod) is an oral, sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5. Zeposia blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of lymphocytes in peripheral blood.
Lead Product(s): Ozanimod
Therapeutic Area: Neurology Product Name: Zeposia
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 26, 2022
Details:
Zeposia (ozanimod) is an oral, sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5 also maintains disease control even in the event of temporary treatment interruption for up to eight weeks.
Lead Product(s): Ozanimod
Therapeutic Area: Gastroenterology Product Name: Zeposia
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 24, 2022
Details:
Results showed improved or preserved cognitive function in a majority of people for Zeposia (ozanimod hydrochloride) with greatest effect observed in almost 80% of people with high thalamic volume at Month 48 of DAYBREAK open-label extension trial.
Lead Product(s): Ozanimod
Therapeutic Area: Neurology Product Name: Zeposia
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 24, 2022
Details:
Zeposia is oral S1P receptor modulator for Ulcerative Colitis. Its approval is based on the Phase 3 True North trial, which demonstrated clinically meaningful improvements in key clinical, endoscopic and mucosal healing endpoints, with no new safety signals observed.
Lead Product(s): Ozanimod
Therapeutic Area: Gastroenterology Product Name: Zeposia
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 23, 2021
Details:
Zeposia (ozanimod) is an oral, sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5 used for treatment of Relapsing forms of multiple sclerosis (MS) and ulcerative colitis (UC) in adults.
Lead Product(s): Ozanimod
Therapeutic Area: Gastroenterology Product Name: Zeposia
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 15, 2021
Details:
The approval is based on data from True North, a pivotal Phase 3 trial evaluating Zeposia as an induction and maintenance therapy versus placebo in adult patients with moderately to severely active ulcerative colitis.
Lead Product(s): Ozanimod
Therapeutic Area: Gastroenterology Product Name: Zeposia
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 27, 2021
Details:
True North is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of Zeposia (ozanimod) 1mg in patients with moderately to severely active ulcerative colitis who did not adequately respond to prior treatment.
Lead Product(s): Ozanimod
Therapeutic Area: Gastroenterology Product Name: Zeposia
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 23, 2021
Details:
The sNDA submitted to the FDA is based on results from True North, a pivotal, placebo-controlled Phase 3 trial evaluating Zeposia as an induction and maintenance therapy in adults with moderately to severely active UC.
Lead Product(s): Ozanimod
Therapeutic Area: Gastroenterology Product Name: Zeposia
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 01, 2021
Details:
ZEPOSIA® (0.92 mg) demonstrated a relative reduction in ARR versus AVONEX® of 48 per cent through one year in the SUNBEAM study and 38 per cent at two years in the RADIANCE study.
Lead Product(s): Ozanimod
Therapeutic Area: Neurology Product Name: Zeposia
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 07, 2020
Details:
EDT to discuss results from the Phase 3 True North trial evaluating Zeposia® (ozanimod) in patients with moderate to severe ulcerative colitis, which will be presented at United European Gastroenterology (UEG) Week 2020.
Lead Product(s): Ozanimod
Therapeutic Area: Gastroenterology Product Name: Zeposia
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 02, 2020
Details:
Oral sphingosine 1-phosphate 1 and 5 receptor agonist Zeposia (ozanimod) achieved all its targets in the True North trial involving adults with moderate-to-severe ulcerative colitis, the first stage in BMS’ drive to get approval for the drug in inflammatory bowel disease.
Lead Product(s): Ozanimod
Therapeutic Area: Gastroenterology Product Name: Zeposia
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 02, 2020
Details:
Study met primary endpoints of clinical remission in induction at Week 10 and in maintenance at Week 52. Zeposia is the first oral sphingosine-1-phosphate (S1P) receptor modulator to demonstrate benefit in moderate to severe ulcerative colitis in a Phase 3 study.
Lead Product(s): Ozanimod
Therapeutic Area: Gastroenterology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 02, 2020
Details:
The CHMP adopted the positive opinion based on data from the randomized, active-controlled Phase 3 SUNBEAM™ and RADIANCE™ Part B clinical trials.
Lead Product(s): Ozanimod
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 27, 2020
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