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Lipocine (LPCN)
NASDAQ:LPCN
Lpcn 1154A
Depression, Postpartum, Depression, Post-Partum, Postpartum Depression (Ppd), Post-Natal Depression, Peripartum Depression, Postnatal Depression
Phase III
Recruiting
A Study to Assess the Safety and Efficacy of Oral LPCN 1154A in Women With Severe PPD
May 13, 2025
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Lpcn 1148
Sarcopenia, Liver Cirrhosis
Phase II
Completed
A Study to Assess the Efficacy, Safety, and Tolerability of Oral LPCN 1148 in Male Subjects With Cirrhosis of the Liver and Sarcopenia
May 03, 2021
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Lpcn 1144
Nash - Nonalcoholic Steatohepatitis
Phase II
Completed
A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial
Dec 08, 2020
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Lpcn 1144 Formulation A, Lpcn 1144 Formulation B
Nonalcoholic Steatohepatitis (Nash)
Phase II
Completed
The Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis
Aug 16, 2019
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Lpcn 1021
Hypogonadism, Male
Phase III
Completed
Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal Men
Feb 21, 2019
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Lpcn 1021
Hypogonadism, Male
Phase III
Completed
Dosing Validation Study of Oral Testosterone Undecanoate (TU, LPCN 1021).
Aug 03, 2017
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Lpcn 1021
Hypogonadism, Male
Phase III
Completed
Dosing Flexibility Study of Oral Testosterone Undecanoate (TU, LPCN 1021)
Aug 03, 2017
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Oral Testosterone Undecanoate, Lpcn 1021, Topical Testosterone Gel 1.62 %
Male Hypogonadism
Phase III
Completed
Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism
Feb 20, 2014
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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 Lipocine (LPCN) have in its pipeline
LPCN is currently developing the following drugs: Lpcn 1154A, Lpcn 1148, Lpcn 1144. These drug candidates are in various stages of clinical development as the company works toward FDA approval.