LIB-01: Dosing Protocols

Important Disclaimer#

LIB-01 is an investigational compound currently in Phase 2 clinical trials conducted by Dicot Pharma. It is not approved for clinical use in any jurisdiction and is not available for purchase. All dosing information below is derived from published clinical trial data and conference presentations. This information is provided for educational purposes only.

Clinical Trial Dosing#

Phase 1 First-in-Human Study (2023)#

The Phase 1 study was a randomized, double-blind, placebo-controlled trial evaluating the safety, tolerability, pharmacokinetics, and pro-erectile effects of LIB-01 in healthy male volunteers.

Single Ascending Dose (SAD) cohort:

• Doses tested: 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg (single oral administration)
• All doses were safe and well tolerated

Multiple Ascending Dose (MAD) cohort:

• Doses tested: Multiple dose levels administered once daily for 3 consecutive days
• The 3-day dosing paradigm was based on the preclinical observation that libiguins produced sustained effects from short-course treatment in rodent models

Key pharmacodynamic findings from the MAD cohort:

• Onset of pro-erectile effect within 7 days of the 3-day dosing course
• Duration of action of at least 28 days after the last dose
• Erectile function improvements demonstrated by both subjective (IIEF-EF questionnaire) and objective (RigiScan nocturnal penile rigidity monitoring) measures

Phase 2a Study (2024-2025)#

The Phase 2a study was a double-blind, placebo-controlled, multi-center trial conducted across 6 clinical sites in Sweden, Denmark, and the Netherlands.

Study population:

• 156 men aged 26-65 years
• Diagnosis of mild to moderate erectile dysfunction
• Randomized to LIB-01 25 mg, LIB-01 50 mg, or placebo

Dosing regimen:

• 3 consecutive days of once-daily oral dosing
• Follow-up assessments at weeks 4 and 8

Key efficacy results (50 mg group):

• IIEF-EF score improvement of 8.5 points from baseline (p=0.008 vs baseline)
• 31% complete responders (IIEF-EF score >25, indicating normal erectile function) vs 0% placebo (p=0.04)
• The 8.5-point improvement exceeded the minimum clinically important difference of 5 points for this severity group
• Effect was sustained through the entire 8-week observation period

Dosing paradigm significance: The 3-day dosing course followed by weeks of sustained effect is unprecedented in ED therapeutics. For comparison:

• PDE5 inhibitors require dosing before each sexual encounter (or daily low-dose for tadalafil)
• Bremelanotide (PT-141) requires subcutaneous injection before each encounter
• LIB-01 requires only 3 days of oral dosing for up to 8 weeks of effect

Administration#

LIB-01 is formulated as an oral tablet (LIB-01 monohydrate). No specific administration instructions regarding food timing or fasting requirements have been publicly disclosed from the clinical trial protocols.

Storage#

As an investigational product available only through clinical trial supply, storage conditions are managed by the clinical trial sponsor (Dicot Pharma) and investigational sites. No commercial storage guidelines are available.

Dosing Context#

LIB-01 belongs to the Reproductive category of research peptides. Dosing protocols for LIB-01 are derived from available clinical trial data. These protocols are provided for research reference only and do not constitute medical advice. Actual dosing decisions should be made by qualified healthcare providers based on individual patient factors.

Research Protocols#

The following dosing protocols have been documented in clinical research for LIB-01:

Erectile Dysfunction (Phase 1 -- Single Ascending Dose)#

Dose: Single oral doses ranging from 10 mg to 150 mg were evaluated in healthy male volunteers.

Frequency: Single dose

Duration: Single administration with follow-up monitoring

Phase 1 SAD cohort evaluated safety and tolerability across a wide dose range. All doses were well tolerated.

Erectile Dysfunction (Phase 1 -- Multiple Ascending Dose)#

Dose: Multiple oral doses ranging from 10 mg to 150 mg daily for 3 consecutive days.

Frequency: Once daily for 3 consecutive days

Duration: 3-day treatment course; effects monitored for at least 28 days

MAD cohort demonstrated the unique pharmacodynamic profile with onset within 7 days and duration of at least 28 days. Erectile function improvements measured by IIEF-EF and RigiScan.

Erectile Dysfunction (Phase 2a)#

Dose: 25 mg or 50 mg oral tablets daily for 3 consecutive days in men with mild to moderate ED.

Frequency: Once daily for 3 consecutive days

Duration: 3-day treatment course; efficacy monitored over 8 weeks

The 50 mg group showed an 8.5-point IIEF-EF improvement with 31% complete responders (IIEF-EF >25) vs 0% placebo. Effects sustained through week 8.

Reconstitution and Preparation#

LIB-01 is administered as an oral tablet. No reconstitution, mixing, or injection preparation is required. The formulation is LIB-01 monohydrate in tablet form.

Injection Sites#

Recommended injection sites for LIB-01 include:

• Not applicable -- LIB-01 is an oral tablet formulation

Site rotation is recommended to minimize local tissue reactions and ensure consistent absorption.

Storage Requirements#

Storage conditions for LIB-01 tablets have not been publicly disclosed by Dicot Pharma. As an investigational product, LIB-01 is only available through clinical trial supply chains with controlled storage and distribution.

Related Reading#

• LIB-01 overview and research guide
• LIB-01 side effects profile
• LIB-01 research evidence