Lipocine (LPCN) hits Phase 3 enrollment milestone for LPCN 1154 in postpartum depression

Rhea-AI Filing Summary

Lipocine Inc. reported that it has completed enrollment and dosing in its Phase 3 clinical trial of LPCN 1154 for postpartum depression. This means all planned participants have entered the study and received the investigational treatment, marking a key operational milestone for the program. The update was shared through a press release, which is included as an exhibit to this report.

Insights

Biopharma clinical development analyst

Lipocine reaches a key Phase 3 trial milestone for LPCN 1154 in postpartum depression.

Lipocine Inc. disclosed that enrollment and dosing are complete in its Phase 3 trial of LPCN 1154 targeting postpartum depression. Completion of enrollment typically signals that the study has advanced to the stage where all participants have received the investigational drug according to the protocol.

This milestone is important because it often precedes collection and analysis of primary endpoint data, although no efficacy or safety results are presented here. The disclosure is limited to operational progress, with no information on trial size, design details, or timelines for data readout in the provided content.

The press release attached as Exhibit 99.1 is indicated as the source of further detail, so subsequent company communications and filings may provide results and regulatory plans once data from this Phase 3 trial of LPCN 1154 in postpartum depression are available.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

The Securities Exchange Act of 1934

Date of Report (Date of Earliest Event Reported):

January 20, 2026

LIPOCINE INC.

(Exact name of registrant as specified in its charter)

Commission File No. 001-36357

Delaware		99-0370688
(State or other jurisdiction of incorporation)		(IRS Employer Identification Number)

675 Arapeen Drive, Suite 202

Salt Lake City, Utah 84108

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code: (801) 994-7383

Former name or former address, if changed since last report: Not Applicable

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications pursuant to Rule 13e-4© under the Exchange Act (17 CFR 240.13©(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.0001 per share		LPCN		The NASDAQ Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR § 230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR § 240.12b-2).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 8.01 Other Events.

On January 20, 2026, the Company issued a press release announcing completion of enrollment and dosing in Phase 3 Trial of LPCN 1154 in postpartum depression (“PPD”). The press release is furnished as Exhibit 99.1 to this report and incorporated by reference herein.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

The following exhibits are filed with this report:

Exhibit No.		Description
99.1		Press Release announcing Completion of Enrollment and Dosing in Phase 3 Trial of LPCN 1154 in Postpartum Depression
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

			LIPOCINE INC.
Date:	January 20, 2026		By:	/s/ Mahesh V. Patel
				Mahesh V. Patel
				President and Chief Executive Officer

FAQ

What did Lipocine (LPCN) report in this 8-K filing?

Lipocine reported that it has completed enrollment and dosing in its Phase 3 clinical trial of LPCN 1154 for postpartum depression, as announced in a press release attached as Exhibit 99.1.

What is LPCN 1154 in Lipocines pipeline?

LPCN 1154 is described as an investigational therapy being studied in a Phase 3 trial for postpartum depression, with the current update focused on completion of enrollment and dosing.

Why is completion of enrollment and dosing in the Phase 3 trial important for Lipocine (LPCN)?

Completion of enrollment and dosing indicates that all planned participants have entered the Phase 3 study and received LPCN 1154, a major step toward generating final clinical data for postpartum depression.

Does this Lipocine 8-K filing include Phase 3 efficacy results for LPCN 1154?

No efficacy or safety results are described in the provided content; it only states that enrollment and dosing are complete in the Phase 3 trial and that more detail is in the press release furnished as Exhibit 99.1.

Where can investors find more details on Lipocines Phase 3 PPD trial of LPCN 1154?

Additional information is indicated to be in the press release furnished as Exhibit 99.1 to this report, which discusses completion of enrollment and dosing in the Phase 3 trial.

Does the 8-K say anything about financial results for Lipocine (LPCN)?

The provided content focuses on the clinical development milestone for LPCN 1154 in postpartum depression and does not describe financial results.