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Asimadoline (TP0052) for Vasomotor Symptoms

This study is testing the safety and effectiveness of a drug called asimadoline (TP0052) for women experiencing moderate to severe vasomotor symptoms (VMS), also known as hot flashes and night sweats. Researchers want to see if asimadoline can help reduce these symptoms. You may be able to join if you are a woman between 40 and 62 years old, have VMS, and have not recently taken other medications for these symptoms. The study will measure safety by looking at any side effects, lab results, and vital signs over 8 weeks. This trial aims to enroll 120 participants.

Study design
This is a Phase 2a randomized, double-blind, placebo-controlled study, meaning some participants will receive asimadoline (TP0052) and others will receive a placebo (an inactive substance), without knowing which they are getting. After 8 weeks, all participants will receive asimadoline in an open-label format for 4 weeks.
What's involved
You would record your VMS daily for 2 weeks before starting treatment. Then, you would take asimadoline (TP0052) or a placebo for 8 weeks, taking four tablets daily (two in the morning and two before bed). There will also be a safety telephone follow-up after treatment.
Compensation
Not stated in the trial record.
Follow-up
You will have a safety telephone follow-up after the 8-week double-blind treatment period. After the 8-week treatment, all patients will receive Asimadoline in an open-label format for 4 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07042516

Safety and Efficacy of Asimadoline (TP0052) in Patients With Vasomotor Symptoms (VMS).

Recruiting
PHASE2Ages 40–62InterventionalTreatment
Tioga Pharmaceuticals
~120 participants
Updated 2025-09-09 on ClinicalTrials.gov
What's tested:Asimadoline

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety as Assessed by Adverse Events, Clinical Laboratory Parameters, and Vital Signs
Measured over baseline to 8 weeks

Conditions

Vasomotor Symptoms

Explore related trials

Vasomotor Symptoms

Where it's being run

1 sites across 1 states
Georgia1

Study leadership

  • Anne Dunlop - Principal Investigator, MD · PRINCIPAL_INVESTIGATOR · Emory University
  • Sergey Sikora, VP of Clinical Affairs, PhD · STUDY_CHAIR · Tioga Pharmaceuticals

Who to contact

Standish Fleming, CEO, MBA
[email protected]
(858) 245-7563
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Females aged 40-62 years.
Untreated patients (either newly diagnosed with VMS or those with a history of VMS but have not been taking drugs that could have an effect on VMS (e.g., SSRIs, SNRIs, gabapentin, pregabalin, clonidine).
Menopausal OR late perimenopausal according to the following criteria:
Women who have had a bi-lateral oophorectomy (\> 6 weeks prior); OR
Women with a uterus who have had no vaginal bleeding the past 12 months; OR
Women without a uterus (or women with a uterus who have either a levonorgestrel intrauterine device \[LNG IUD\] or who have had an endometrial ablation) and who still have one or both ovaries, with follicle stimulating hormone (FSH) level \> 40 mIU/mL and estradiol ≤ 50 pg/mL (on at least one of two blood draws two weeks apart);
Women with a uterus who have had consecutive intervals of amenorrhea of at least 60 days for three or more cycles (i.e., three consecutive episodes of vaginal bleeding separated by 60 or more days between vaginal bleeding episodes).
Including at least 6 moderate to severe VMS per day on 4 or more days in each of the 2 screening weeks.
VMS frequency in week 2 cannot drop by more than 50% from the average weekly level reported during week 1.
In general good health as determined by medical history, blood pressure, and heart rate.
Signed informed consent.

Exclusion

• Use of hormone therapy or hormonal contraceptives (with the exception of the LNG IUD) during the 8 weeks before Screening Visit 1. Use of low-dose vaginal estrogen therapies is allowed, with the exception of vaginal creams used \>3 times a week.
Use of non-hormonal medications that can influence VMS during the 4 weeks before Screening Visit 1, including selective serotonin reuptake inhibitors (SSRIs), selective serotonin-norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin, and clonidine.
Use of marijuana or cannabis-derived products (including THC or CBD in any form other than topical, including smoked, vaporized, or edible) that can affect central thermoregulatory processes, mood and perception of VMS, and potentially have pharmacodynamic interactions with the asimadoline during the 4 weeks before Screening Visit 1 as determined by interview and urine drug test.
Use of supplements or herbal therapies that can affect VMS including black cohosh, red clover, dong quai, evening primrose oil, maca, ginseng, chasteberry, milk thistle, and phytoestrogens during the 4 weeks before Screening Visit 1.
Any current severe or unstable medical illness, including the following:
Hypertension of stage 2 or greater (systolic blood pressure ≥ 140 or diastolic blood pressure ≥ 90)
Resting heart rate \>100.
Current cancer diagnosis, except non-melanoma skin cancer, or any findings suggestive of or indicating breast malignancy.
Current abnormal Pap smear, breast exam, or mammogram.
Coronary artery disease, or cerebrovascular disease.
Moderate to severe substance use disorder in the previous 12 months; suicide attempt in the previous 36 months, any major depressive episode within the previous 12 months, or lifetime diagnosis of psychosis or bipolar disorder.
Pregnancy, intending pregnancy, breast feeding.
Current participation in another drug trial or intervention study.
Inability or unwillingness to complete the study procedures.
Known hypersensitivity to asimadoline TP0052.
Chronic liver or renal disease, or uncontrolled seizure disorder.
Use of medications or supplements that act as an inhibitor of P-glycoprotein or as a P-glycoprotein substrate during the 4 weeks prior to Screening Visit 1, including cyclosporine, non-topical ketoconazole, verapamil, digoxin, colchicine, sitagliptin).
Blood test results indicating:
Liver function tests: AST ≥2 times upper limit of normal; ALT ≥2 times upper limit of normal; total bilirubin ≥ 1.5 times upper limit of normal
Kidney function test: estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m²
Blood count: hematocrit \<30%.

What this trial measures

  • Safety as Assessed by Adverse Events, Clinical Laboratory Parameters, and Vital Signsbaseline to 8 weeks

    Safety will be evaluated based on the incidence and severity of adverse events and changes from baseline in laboratory values and vital signs. Adverse events will be graded using the Common Terminology Criteria for Adverse Events, Version 5.0 (grade 1 = mild; grade 5 = death; higher scores indicate worse outcomes). Liver function tests include alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase, alkaline phosphatase, and total bilirubin. Higher values indicate worse liver function. Kidney function will be assessed by estimated glomerular filtration rate (scale: 0 to ≥90 mL/min/1.73 m²; \<60 considered abnormal; higher is better). Hematocrit will be monitored (percent; \<30% is abnormal; higher is better within normal range). Vital signs include blood pressure, heart rate, respiratory rate, and oral temperature; higher blood pressure and heart rate indicate worse outcomes. A urine pregnancy test (positive or negative) will also be performed.