RegulatoryCompany release

Lipocine wins Health Canada approval for TLANDO and starts Phase 3 postpartum depression trial

🇺🇸 Lipocine Inc. (LPCN) · Thu 05 Nov 2026

The US company reported a $0.7 million third-quarter net loss, alongside Canadian clearance for its oral testosterone and the start of the BLOOM study of LPCN 1154.

Lipocine Inc. reported results for the quarter ended 30 September 2026 on 5 November, showing a net loss of $0.7 million and revenue of $2.3 million. Most of the revenue came from licence and collaboration income.

In September, Health Canada approved TLANDO (testosterone undecanoate) capsules for male hypogonadism. The United Arab Emirates had already authorised the same product under the name TESTYRA in July 2026. Lipocine plans to launch in both Canada and the UAE in early 2027.

On the development side, the company has begun the Phase 3 BLOOM study of LPCN 1154, an oral formulation of brexanolone, in postpartum depression. The study is intended to support a 505(b)(2) new drug application and follows feedback from the US Food and Drug Administration.

As general context, a 505(b)(2) application is a US route that allows a sponsor to rely partly on existing data, such as published literature or previous agency findings, rather than generating all evidence itself. The source material provided gave no further detail on the BLOOM trial design or timelines.

What it means for your team

  • Market-access teams should note the planned early-2027 launches in Canada and the UAE, which add two markets for TLANDO outside the US.
  • Regulatory teams tracking testosterone products can see the same product authorised under different names, TLANDO in Canada and TESTYRA in the UAE.
  • Those following neuropsychiatric pipelines should watch BLOOM, as it is a Phase 3 study intended to support a 505(b)(2) filing for oral brexanolone in postpartum depression.

Company's press release (SEC filing): Lipocine Inc. ↗

Article written by VigiEye from the official source (Lipocine Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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