X
API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
Other Certificates
Other Suppliers
USA (Orange Book)
Europe
Canada
Australia
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
Details:
TEV-44749 (olanzapine) is a novel D2/5-HT2 receptor inhibitor which is under phase 3 clinical development for the treatment of patients with Schizophrenia.
Lead Product(s): Olanzapine
Therapeutic Area: Psychiatry/Psychology Product Name: TEV-44749
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Teva Pharmaceutical Industries
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 09, 2024
Details:
Lybalvi (olanzapine and samidorphan) is a once-daily, oral atypical antipsychotic drug. It is approved by USFDA for treatment of adults with schizophrenia, and for the treatment of adults with bipolar I disorder.
Lead Product(s): Olanzapine,Samidorphan L-Malate
Therapeutic Area: Psychiatry/Psychology Product Name: Lybalvi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 03, 2024
Details:
The collaboration aims to co-develop and co-commercialize asset TEV’574, a novel anti-TL1A therapy, currently in Phase 2b clinical trials for the treatment of Ulcerative Colitis and Crohn's Disease, two types of inflammatory bowel disease.
Lead Product(s): Olanzapine
Therapeutic Area: Psychiatry/Psychology Product Name: TEV-‘749
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sanofi
Deal Size: $1,500.0 million Upfront Cash: $500.0 million
Deal Type: Collaboration November 30, 2023
Details:
The collaboration aims to accelerate the clinical research program for Teva’s TEV-‘749 (olanzapine), a once-monthly subcutaneous long-acting injection of the atypical antipsychotic olanzapine that is currently in Phase 3 for the treatment of schizophrenia.
Lead Product(s): Olanzapine
Therapeutic Area: Psychiatry/Psychology Product Name: TEV-‘749
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Royalty Pharma
Deal Size: $125.0 million Upfront Cash: Undisclosed
Deal Type: Collaboration November 13, 2023
Details:
The proceeds from the new bonds will be used to finance the acquisition of the worldwide commercial rights for Zyprexa (olanzapine), an antipsychotic medication, from Eli Lilly and Company.
Lead Product(s): Olanzapine
Therapeutic Area: Psychiatry/Psychology Product Name: Zyprexa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $825.9 million Upfront Cash: Undisclosed
Deal Type: Private Placement April 28, 2023
Details:
Olanzapine is an atypical antipsychotic that exerts its action primarily on dopamine and serotonin receptors. It works on dopamine D2 receptors in the mesolimbic pathway as an antagonist, blocking dopamine from potential action at the post-synaptic receptor.
Lead Product(s): Olanzapine
Therapeutic Area: Psychiatry/Psychology Product Name: Olanzapine-Generic
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 11, 2023
Details:
mdc-TJK (olanzapine) is a thienobenzodiazepine classified as an atypical or second-generation antipsychotic agent. It works on dopamine D2 receptors in the mesolimbic pathway as an antagonist, blocking dopamine from potential action at the post-synaptic receptor.
Lead Product(s): Olanzapine
Therapeutic Area: Psychiatry/Psychology Product Name: TV-44749
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 January 24, 2023
Details:
The Phase 3 study will assess the efficacy and safety of potentially the first subcutaneous long-acting Injectable (LAI) formulation of mdc-TJK (olanzapine) for the treatment of patients with schizophrenia.
Lead Product(s): Olanzapine
Therapeutic Area: Psychiatry/Psychology Product Name: mdc-TJK
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Teva Pharmaceutical Industries
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration August 29, 2022
Details:
INP105 (olanzapine) is being developed as an acute treatment for agitation in persons with autism spectrum disorder (ASD) using Impel’s proprietary Precision Olfactory Delivery (POD®) technology which delivers drugs to the upper nasal space.
Lead Product(s): Olanzapine
Therapeutic Area: Neurology Product Name: INP105
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 19, 2022
Details:
LYBALVI (olanzapine and samidorphan), an atypical antipsychotic drug approved in U.S. for treatment of adults with schizophrenia and for treatment of adults with bipolar I disorder.
Lead Product(s): Olanzapine,Samidorphan L-Malate
Therapeutic Area: Psychiatry/Psychology Product Name: Lybalvi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 07, 2022
Details:
STAR-OLZ has previously completed Phase 1 in-human bioavailability (BA) studies which demonstrated the transdermal patch has acceptable local tolerability over the 5-day dosing interval and delivers approximately 60% less drug than the oral form.
Lead Product(s): Olanzapine
Therapeutic Area: Oncology Product Name: STAR-OLZ
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 04, 2022
Details:
STAR-OLZ is a multi-day transdermal (TDS) delivery system of olanzapine, which has been shown to be a powerful antiemetic, but is not currently approved for nausea or vomiting indications.
Lead Product(s): Olanzapine
Therapeutic Area: Oncology Product Name: STAR-OLZ
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 16, 2021
Details:
In the ENLIGHTEN clinical development program, LYBALVI demonstrated antipsychotic efficacy, safety and tolerability, including statistically significantly less weight gain than olanzapine in patients with schizophrenia in the ENLIGHTEN-2 study.
Lead Product(s): Olanzapine,Samidorphan L-Malate
Therapeutic Area: Psychiatry/Psychology Product Name: Lybalvi
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 01, 2021
Details:
Highlights of the presentations include: A clinical overview of olanzapine/samidorphan (LYBALVI™), formerly referred to as ALKS 3831, consisting of 18 clinical studies, evaluating LYBALVI's antipsychotic efficacy and weight mitigation profile along with its safety data.
Lead Product(s): Olanzapine,Samidorphan L-Malate
Therapeutic Area: Psychiatry/Psychology Product Name: Lybalvi
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 03, 2021
Details:
The company's presentations included new exploratory analyses from the phase 3 ENLIGHTEN-2 study of olanzapine/samidorphan (LYBALVI™), formerly referred to as ALKS 3831.
Lead Product(s): Olanzapine,Samidorphan L-Malate
Therapeutic Area: Psychiatry/Psychology Product Name: Lybalvi
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 April 20, 2021
Details:
Under the terms of the agreement, Starton will receive an undisclosed upfront cash payment and is eligible to receive additional development and regulatory milestone payments, plus double-digit royalties on annual net sales of STAR-OLZ in the territory.
Lead Product(s): Olanzapine
Therapeutic Area: Gastroenterology Product Name: STAR-OLZ
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Haisco Pharmaceutical
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement March 01, 2021
Details:
U.S. Food and Drug Administration (FDA) has acknowledged receipt of the company's New Drug Application (NDA) resubmission for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophrenia and adults with bipolar I disorder.
Lead Product(s): Samidorphan L-Malate,Olanzapine
Therapeutic Area: Psychiatry/Psychology Product Name: ALKS 3831
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 December 29, 2020
Details:
The AdCom will likely question whether or not ALKS-3831, a formulation of samidorphan and generically available olanzapine, provided a clinically meaningful reduction in the common weight gain side effect versus olanzapine.
Lead Product(s): Samidorphan L-Malate,Olanzapine
Therapeutic Area: Psychiatry/Psychology Product Name: ALKS 3831
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 November 17, 2020
Details:
The committees voted 16-1 that samidorphan meaningfully mitigates olanzapine-associated weight gain and also ruled that the safety profile of the drug has been adequately characterised by 13-3.
Lead Product(s): Samidorphan L-Malate,Olanzapine
Therapeutic Area: Psychiatry/Psychology Product Name: ALKS 3831
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 09, 2020
Details:
ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder.
Lead Product(s): Samidorphan L-Malate,Olanzapine
Therapeutic Area: Psychiatry/Psychology Product Name: ALKS 3831
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 07, 2020
Details:
The company presented six posters, one of which focused on new outcomes research that analyzed treatment challenges of second-generation antipsychotics, such as weight gain and treatment interruptions, in patients living with schizophrenia or bipolar I disorder.
Lead Product(s): Samidorphan L-Malate,Olanzapine
Therapeutic Area: Psychiatry/Psychology Product Name: ALKS 3831
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 September 14, 2020
Details:
ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder.
Lead Product(s): Samidorphan L-Malate,Olanzapine
Therapeutic Area: Psychiatry/Psychology Product Name: ALKS 3831
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 August 21, 2020
Details:
ENLIGHTEN-2 is the second of two key studies included in the ALKS 3831 ENLIGHTEN clinical development program.
Lead Product(s): Samidorphan L-Malate,Olanzapine
Therapeutic Area: Psychiatry/Psychology Product Name: ALKS 3831
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 August 17, 2020
Details:
Olanzapine is indicated for the treatment of schizophrenia and bipolar disorder. The drug may also be used in combination with other medication to treat depression and certain mental conditions.
Lead Product(s): Olanzapine
Therapeutic Area: Psychiatry/Psychology 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 August 06, 2020
Details:
Study shows INP105 achieves rapid absorption which may provide an effective, convenient, & noninvasive future alternative for treating acute agitation in the home, community, or hospital setting.
Lead Product(s): Olanzapine
Therapeutic Area: Psychiatry/Psychology Product Name: INP105
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 30, 2020
Details:
E-poster presentations include results from completed 52-week, open-label safety study of Alks 3831 in patients with schizophrenia.
Lead Product(s): Olanzapine,Samidorphan L-Malate
Therapeutic Area: Psychiatry/Psychology 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 May 14, 2020
Details:
ENLIGHTEN-1 was a four-week study evaluating the efficacy, safety and tolerability of ALKS 3831 compared to placebo in 403 patients experiencing an acute exacerbation of schizophrenia.
Lead Product(s): Olanzapine,Samidorphan L-Malate
Therapeutic Area: Psychiatry/Psychology 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 March 04, 2020
Details:
The ALKS 3831 NDA includes data from the ENLIGHTEN clinical development program in patients with schizophrenia, as well as pharmacokinetic (PK) bridging data comparing ALKS 3831 and ZYPREXA.
Lead Product(s): Olanzapine,Samidorphan L-Malate
Therapeutic Area: Psychiatry/Psychology 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 January 28, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] 
Market Place
