X
[{"orgOrder":0,"company":"Lipocine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lipocine Announces Regulatory Path Forward for TLANDO\u2122 Resubmission","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2020","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase III"},{"orgOrder":0,"company":"Lipocine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"U.S. FDA Denies Clarus's Oral Testosterone Ester Citizen Petition","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2020","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase III"},{"orgOrder":0,"company":"Lipocine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Clears LPCN 1148 IND Application for Phase 2 Cirrhosis Trial","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"IND Enabling"},{"orgOrder":0,"company":"Lipocine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lipocine Announces Presentations on TLANDO\u2122 at AUA Virtual Experience 2020","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2020","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II"},{"orgOrder":0,"company":"Lipocine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Treatment Potential of LPCN 1144 Demonstrated in a Pre-Clinical NASH and Hepatic Fibrosis Model","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II"},{"orgOrder":0,"company":"Lipocine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lipocine Announces Publication of LPCN 1144 Liver Fat Study (\"LFS\") Results","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2020","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II"},{"orgOrder":0,"company":"Lipocine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lipocine Provides Regulatory Update for TLANDO\u2122","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2020","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase III"},{"orgOrder":0,"company":"Lipocine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lipocine Announces Completion of Enrollment in the LPCN 1144 LiFT Study","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II"},{"orgOrder":0,"company":"Lipocine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lipocine Announces Presentations at the 21st Annual Fall Meeting of the Sexual Medicine Society of North America","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2020","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase III"},{"orgOrder":0,"company":"Lipocine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lipocine to Present Preclinical Data on Therapeutic Potential of LPCN 1144 in Hepatic Fibrosis and NASH","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II"},{"orgOrder":0,"company":"Lipocine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Clears LPCN 1154 IND Application for a Phase 2 Postpartum Depression Study","therapeuticArea":"Neurology","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2021","url1":"","url2":"","graph1":"Neurology","graph2":"IND Enabling"},{"orgOrder":0,"company":"Lipocine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lipocine's LPCN 1144 Met Non-Alcoholic Steatohepatitis (\"NASH\") Resolution Regulatory Endpoint in Phase 2 LiFT Study","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2021","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II"},{"orgOrder":0,"company":"Lipocine","sponsor":"Antares Pharma","pharmaFlowCategory":"D","amount":"$25.0 million","upfrontCash":"$11.0 million","newsHeadline":"Antares Pharma Enters into Exclusive License Agreement With Lipocine for TLANDO\u00ae in U.S.","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2021","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"Lipocine","sponsor":"Antares Pharma","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Antares Pharma Announces FDA Approval Of TLANDO, an Oral Treatment for Testosterone Replacement Therapy","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"Lipocine","sponsor":"Antares Pharma","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Approves TLANDO\u00ae (testosterone undecanoate), an Oral Treatment for Testosterone Replacement Therapy by Antares Pharma, Inc., developed by Lipocine Inc.","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"Lipocine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lipocine Granted US Patents Directed To CNS And Liver Programs","therapeuticArea":"Neurology","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Preclinical"},{"orgOrder":0,"company":"Lipocine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Clears LPCN 2101 IND for Adult Epilepsy Treatment","therapeuticArea":"Neurology","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2022","url1":"","url2":"","graph1":"Neurology","graph2":"IND Enabling"},{"orgOrder":0,"company":"Lipocine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lipocine Announces Favorable Regulatory Pathway on Oral LPCN 1154 for Post-Partum Depression (PPD)","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase II"},{"orgOrder":0,"company":"Lipocine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lipocine Announces Strategic Realignment and Forward Focus on Treating CNS Disorders","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase II"},{"orgOrder":0,"company":"Lipocine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lipocine Completes Enrollment of LPCN 1148 Phase 2 Study for Decompensated Cirrhosis","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2022","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II"},{"orgOrder":0,"company":"Lipocine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"First Subject Dosed in the Clinical Bridge Study with Lipocine Depression Candidate, LPCN 1154","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2023","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase II"},{"orgOrder":0,"company":"Lipocine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"LPCN 1148 Phase 2 Study Meets Primary Endpoint in Patients with Cirrhosis","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2023","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II"},{"orgOrder":0,"company":"Lipocine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lipocine Completes Successful Meeting with FDA on LPCN 1154 in Postpartum Depression","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase II"},{"orgOrder":0,"company":"Lipocine","sponsor":"Verity Pharmaceuticals Inc","pharmaFlowCategory":"D","amount":"$270.0 million","upfrontCash":"$2.5 million","newsHeadline":"Lipocine and Verity Pharma Enter into License Agreement for TLANDO\u00ae Franchise in the U.S. and Canada","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2024","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"Lipocine","sponsor":"Verity Pharmaceuticals Inc","pharmaFlowCategory":"D","amount":"$270.0 million","upfrontCash":"$2.5 million","newsHeadline":"Lipocine Announces Continued Commercialization of TLANDO\u00ae Through Verity Pharmaceuticals","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2024","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"Lipocine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lipocine Announces First Cohort Dosed in Pivotal Study of LPCN 1154","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2024","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase II"},{"orgOrder":0,"company":"Lipocine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lipocine Announces Positive Week 52 Results from LPCN 1148 Phase 2 Study in Patients with Cirrhosis","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2024","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II"},{"orgOrder":0,"company":"Lipocine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lipocine Announces Confirmation of Dosing Regimen for Pivotal Study of LPCN 1154","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2024","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase II"},{"orgOrder":0,"company":"Lipocine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lipocine Announces Positive LPCN 2401 Clinical Results Showing Improved Body Composition in Participants with Obesity","therapeuticArea":"Nutrition and Weight Loss","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2024","url1":"","url2":"","graph1":"Nutrition and Weight Loss","graph2":"Phase II"}]
Find Clinical Drug Pipeline Developments & Deals by Lipocine
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Companies By Therapeutic Area
Details:
LPCN 2401, an oral proprietary combination of anabolic androgen receptor agonist (Testosterone Undecanoate) and α-tocopherol, an antioxidant, is being investigated for the treament of obesity.
Lead Product(s):
Testosterone Undecanoate ,Vitamin E
Therapeutic Area: Nutrition and Weight Loss
Product Name: LPCN 2401
Highest Development Status: Phase II
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
April 11, 2024
Details:
LPCN 1148 is a novel prodrug of androgen receptor agonist for oral administration with compelling multi modal action to improve liver and muscle function, resulting in improved quality of life while awaiting liver transplant, decreased hospital admissions.
Lead Product(s):
Testosterone Dodecanoate
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder)
Product Name: LPCN 1148
Highest Development Status: Phase II
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
March 28, 2024
Details:
LPCN 1154 (brexanolone) is a neuroactive steroid gamma-aminobutyric acid (GABA) A
receptor positive modulator. It is being evaluated for the treatment of postpartum depression.
Lead Product(s):
Brexanolone
Therapeutic Area: Psychiatry/Psychology
Product Name: LPCN 1154
Highest Development Status: Phase II
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
March 25, 2024
Details:
LPCN 1154 (brexanolone) is an oral neurosteroid, a positive allosteric modulator of GABAA receptors. It is being evaluated in phase 2 clinical trials for the treatment of postpartum depression.
Lead Product(s):
Brexanolone
Therapeutic Area: Psychiatry/Psychology
Product Name: LPCN 1154
Highest Development Status: Phase II
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
February 06, 2024
Details:
Verity will market TLANDO (testosterone undecanoate), the first and only oral testosterone replacement therapy in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone, in the United States and, if approved, in Canada.
Lead Product(s):
Testosterone Undecanoate
Therapeutic Area: Endocrinology
Product Name: Tlando
Highest Development Status: Approved
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Verity Pharmaceuticals Inc
Deal Size: $270.0 million
Upfront Cash: $2.5 million
Deal Type: Licensing Agreement
February 02, 2024
Details:
Under the agreement, Verity Pharma will market Tlando (testosterone undecanoate), the first and only oral testosterone replacement therapy (TRT), in the United States and, if approved, in Canada.
Lead Product(s):
Testosterone Undecanoate
Therapeutic Area: Endocrinology
Product Name: Tlando
Highest Development Status: Approved
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Verity Pharmaceuticals Inc
Deal Size: $270.0 million
Upfront Cash: $2.5 million
Deal Type: Licensing Agreement
January 18, 2024
Details:
LPCN 1154 is targeted to be a differentiated oral option with rapid-onset, robust efficacy, and short treatment duration as a mono or add-on therapy for patients with unresolved depression symptoms.
Lead Product(s):
Brexanolone
Therapeutic Area: Psychiatry/Psychology
Product Name: LPCN 1154
Highest Development Status: Phase II
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
October 26, 2023
Details:
LPCN 1148 is an oral prodrug of bioidentical testosterone being developed in Phase 2 clinical study for the management of symptoms associated with cirrhosis.
Lead Product(s):
LPCN 1148
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder)
Product Name: LPCN 1148
Highest Development Status: Phase II
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
July 27, 2023
Details:
LPCN 1154 is an oral formulation of the neuroactive steroid brexanolone for self-administration in development for the treatment of PPD. The active moiety in LPCN 1154 is a bioidentical positive allosteric modulator of y-aminobutyric acid (GABA) receptor.
Lead Product(s):
Brexanolone
Therapeutic Area: Psychiatry/Psychology
Product Name: LPCN 1154
Highest Development Status: Phase II
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
April 03, 2023
Details:
LPCN 1148 is a novel prodrug of androgen receptor agonist for oral administration with compelling multi modal action to improve liver and muscle function, resulting in improved quality of life while awaiting liver transplant, decreased hospital admissions.
Lead Product(s):
LPCN 1148
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder)
Product Name: LPCN 1148
Highest Development Status: Phase II
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
December 19, 2022