Lipocine Announces Peer-Reviewed Publication of Phase 3 Study Results for

Announces Peer-Reviewed Publication of Phase 3 Study Results for TLANDO

LAKE CITY, January 27, 2022 - Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic

and endocrine disorders, today announced the peer-reviewed publication of positive Phase 3 clinical data from the Dosing Validation ("DV")

study which evaluated the fixed-dose oral testosterone undecanoate, TLANDO, for the treatment of hypogonadism. As previously disclosed,

the DV study met its primary endpoint, with TLANDO restoring testosterone levels to the normal range in hypogonadal males. The paper,

entitled "A New Oral Testosterone (TLANDO) Treatment Regimen Without Dose Titration Requirement for Male Hypogonadism," is

published in Andrology and can be found online here.

U.S. Food and Drug Administration ("FDA") previously granted tentative approval to TLANDO in adult males indicated for conditions

associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic

hypogonadism (congenital or acquired).

are pleased by the publication of our positive Phase 3 DV study results," said Dr. Mahesh Patel, Chairman, President, and Chief

Executive Officer of Lipocine. "The primary efficacy results confirm that TLANDO administered without dose titration restores testosterone

levels to the normal range in hypogonadal men. We believe TLANDO's easy to use and prescribe attributes, no titration requirement

and meal flexibility, are preferred by patients and physicians and could be an important differentiated attribute profile for TLANDO,

Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary

drug delivery technologies. Lipocine's clinical development pipeline includes: TLANDO , TLANDO XR, LPCN 1144, LPCN 1148, LPCN

1107 and oral neurosteroids. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, has received tentative

approval from the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males.

TLANDO XR, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone

product with potential for once-daily dosing. In a phase 2 clinical evaluation when administered as once or twice daily, TLANDO XR met

the typical primary and secondary endpoints. LPCN 1144, an oral prodrug of bioidentical testosterone, recently completed a Phase 2 clinical

study demonstrating potential utility in the treatment of non-cirrhotic NASH. LPCN 1148 is an oral prodrug of bioidentical testosterone

targeted for the management of symptoms associated with liver cirrhosis. LPCN 1107 is potentially the first oral hydroxyprogesterone

caproate product candidate indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the

FDA. For more information, please visit www.lipocine.com.

This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private

Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding Lipocine's product candidates

and related clinical trials, the timing of completion of clinical trials, the timing and completion of regulatory reviews, outcomes of

clinical trials of our product candidates, the potential uses and benefits of our product candidates, and our product development efforts.

Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the

risks that the FDA will not approve any of our products, risks related to our products, expected product benefits not being realized,

clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the

FDA approval process including the receipt of regulatory approvals, the results and timing of clinical trials, patient acceptance of

Lipocine's products, the manufacturing and commercialization of Lipocine's products, and other risks detailed in Lipocine's

filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained

on the SEC website at www.sec.gov. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained

in this release, except as required by law.

further information:

Accounting Officer and Corporate Controller