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LPCN 1148 · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| LPCN 1148 | EXPERIMENTAL | Oral LPCN 1148 capsules, administered as BID. |
| Placebo | PLACEBO_COMPARATOR | Oral matching placebo capsules, administered as BID. |
| Name | Type | Description |
|---|---|---|
| LPCN 1148 | DRUG | LPCN 1148 is an oral capsule product containing an ester prodrug of bioidentical testosterone, designed to enable absorption via intestinal lymphatics. |
| Placebo | DRUG | Oral matching placebo capsule |
Inclusion Criteria: 1. Male ≥ 18 years old 2. Currently listed, on the liver transplant waitlist for cirrhosis secondary to Hepatitis B or C infection, Alcoholic Liver Disease (ALD), Non-Alcoholic Steatohepatitis (NASH), Primary Biliary Cholangitis (PBC), or Primary Sclerosing Cholangitis (PSC) 3. ...
LPCN 1148 is an investigational small molecule being developed for liver cirrhosis, specifically for male subjects with cirrhosis of the liver and sarcopenia. It is currently in Phase 2 clinical development and has not been approved by the FDA.
LPCN 1148 is being developed by Lipocine Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol LPCN. The company is conducting clinical trials to evaluate the drug's efficacy, safety, and tolerability in patients with liver cirrhosis and sarcopenia.
LPCN 1148 is in Phase 2 clinical development. It has completed one Phase 2 trial, and the drug is still investigational, meaning it has not received FDA approval. The FDA has granted it Fast Track designation for this indication.
LPCN 1148 has one completed Phase 2 clinical trial, NCT04874350, which assessed the efficacy, safety, and tolerability of oral LPCN 1148 in male subjects with cirrhosis of the liver and sarcopenia. The trial enrolled 30 participants in the United States and was randomized, double-blind, and placebo-controlled.
No, LPCN 1148 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development. The FDA has granted it Fast Track designation, which is intended to facilitate development and expedite review, but the drug has not yet been approved for any use.