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Vasomotor SymptomsPhase 2NCT07042516

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

A Phase 2 study testing Asimadoline in people with Vasomotor Symptoms, run by Tioga Pharmaceuticals at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This Phase 2a randomized, double-blind, placebo-controlled study evaluates the safety and efficacy of asimadoline (TP0052), a peripherally restricted selective kappa-opioid receptor agonist, for moderate to severe menopausal vasomotor symptoms (VMS) in women aged 40-62 years. Read more about this study

Who is it for?
Ages 40 to 62 years, women only
Conditions the study is for
Vasomotor Symptoms
What is being tested?
Asimadoline
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteUnited States
Study dates
13 Aug 2025to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 62 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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:
  • Criteria for Menopause:
  • 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
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  • 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);
  • Criteria for Late Perimenopause:
  • 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).
  • At least 40 moderate to severe VMS per week for each of the 2 screening weeks, as reported on daily VMS diaries.
  • 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.

Who cannot join

  • 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.
  • For perimenopausal participants with a uterus and at least one ovary, an effective non-hormonal method of contraception must be used throughout study participation. Acceptable methods include barrier contraception, copper intrauterine device, surgical sterilization of the male partner, or true abstinence. Hormonal contraceptives remain prohibited, with the exception of levonorgestrel-releasing intrauterine devices (LNG IUDs), as specified above.
  • 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:
Show all 23Show fewer
  • 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.
  • Trial-Specific Exclusion Criteria:
  • 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%.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Standish Fleming, CEO, MBA contact

(858) 245-7563

fleming@tiogapharma.com

Garet Heintz, Regulatory Consultant and Agent, RAC contact

858-571-1800 ext. 105

gheintz@therapeuticsinc.com

United States1 site, 1 recruiting

  • Department of Gynecology & Obstetrics, Emory University School of Medicine

    Atlanta, Georgia, 30329

    Tanja Associate Director, MA, (404) 712-5063, tmletzk@emory.edu

    Recruiting

Other trials in United States

About this study

Official title: Safety and Efficacy of Asimadoline (TP0052), a Peripherally Restricted Selective Kappa Agonist, for the Treatment of Moderate to Severe Menopausal Symptoms in Midlife Women.

This Phase 2a randomized, double-blind, placebo-controlled study evaluates the safety and efficacy of asimadoline (TP0052), a peripherally restricted selective kappa-opioid receptor agonist, for moderate to severe menopausal vasomotor symptoms (VMS) in women aged 40-62 years. Following screening and baseline VMS diary collection, eligible participants are randomized 1:1 to oral asimadoline 5 mg twice daily or matching placebo for 8 weeks. Following the double-blind treatment period, all participants receive 4 weeks of open-label asimadoline, with a safety telephone assessment at approximately Week 12.

Participants enrolled following implementation of Protocol Version 3.0 may elect to undergo optional noninvasive vascular assessments at Baseline and Week 8. These include brachial artery flow-mediated dilation (FMD), digital pulse amplitude tonometry (PAT), carotid-femoral pulse wave velocity (PWV), and radial pulse-wave analysis, including augmentation index normalized to a heart rate of 75 beats per minute (AIx@75). These exploratory assessments evaluate endothelial function, arterial stiffness, and central hemodynamics. Participation is voluntary, and participants may decline or discontinue the vascular assessments without affecting eligibility for or continued participation in the main study.

Being tested
Asimadoline
Keywords
vasomotor symptoms, VMS, asimadoline, perimenopausal, postmenopausal, hot flashes
Medical subject headings
Hot Flashes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AsimadolineDrug

    Also called TP0052

    Asimadoline TP0052 2.5 mg two (2) tablets bid (two on awakening and two before bed), total of four (4) tablets daily (10 mg) for 8 weeks.

Study groups in NCT07042516
Study groupRoleWhat they receive
AsimadolineExperimentalAsimadoline TP0052 2.5 mg two (2) tablets bid (two on awakening and two before bed), total of four (4) tablets daily (10 mg) for 8 weeks. Post-unblinding 4 weeks of open label administration, TP0052 2.5 mg two (2) tablets bid (two on awakening and two before bed), total of four (4) tablets daily (10 mg) for 4 weeks.
Receives: Drug: Asimadoline
PlaceboPlacebo comparatorPlacebo two (2) tablets bid (two on awakening and two before bed), total of four (4) tablets daily for 8 weeks.
Receives: Drug: Asimadoline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety as Assessed by Adverse Events, Clinical Laboratory Parameters, and Vital Signs

    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.

    Measured: baseline to 8 weeks

Secondary outcomes (2)

  1. Change in Frequency of Moderate to Severe Vasomotor Symptoms (VMS)

    The frequency of moderate and severe vasomotor symptoms (VMS) will be measured using participant-completed diaries (paper or electronic) recorded twice daily (morning and evening) from Baseline to Week 8.

    VMS frequency is defined as the number of moderate or severe hot flashes or night sweats reported per day.

    Moderate VMS: sensation of heat with sweating, without disruption of activity. Severe VMS: sensation of heat with sweating that causes cessation of activity or awakening at night.

    The outcome is calculated as the average number of moderate/severe VMS episodes per day, averaged over the 8-week treatment period.

    Due to protocol-defined eligibility criteria, all participants will report at least 40 moderate/severe VMS episodes per week at baseline. During treatment, the minimum possible observed value is 0 episodes/day. There is no fixed upper limit; values of 20-30 episodes/day may occur.

    Higher values indicate worse symptom frequency.

    Measured: Baseline to 8 weeks

  2. Change in Severity-Weighted Vasomotor Symptom (VMS) Score (Composite Severity Index).

    VMS severity will be assessed using a composite score derived from participant diaries recorded twice daily from Baseline to Week 8.

    Each VMS episode is assigned a severity score:

    Mild = 1 Moderate = 2 Severe = 3

    Daily VMS severity scores are calculated as:

    (# Mild × 1) + (# Moderate × 2) + (# Severe × 3)

    Weekly averages of daily severity scores are computed for each participant. The average across the 8-week treatment period will serve as the outcome measure.

    Due to protocol-defined eligibility criteria, all participants will report ≥40 moderate/severe VMS episodes per week at baseline. During treatment, the minimum possible observed value is 0. There is no fixed upper limit; for example, 10 severe episodes per day would result in a score of 30.

    Higher scores indicate worse symptom severity.

    Measured: Baseline to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2025
  2. Study start13 Aug 2025
  3. Primary completion31 Oct 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07042516
Sponsor's protocol ID
TIOGA VMS-08
Other IDs
IND#: 160,058, IRB Tracking Number: 20250414
Status last verified
Oct 2026
First submitted
19 Jun 2025
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Description: De-identified individual participant data (IPD) will be made available to qualified researchers upon reasonable request. Access will be granted following approval of a research proposal and execution of a data-sharing agreement. Data will be shared through a secure platform to ensure confidentiality and compliance with applicable regulations. The shared data may include clinical study reports, anonymized participant-level datasets, and relevant supporting documentation. Time Frame: Data will be available upon publication of the primary study results and for a period of 5 years thereafter. Access Criteria: Researchers must submit a detailed proposal outlining the intended use of the data. Proposals will be reviewed by an independent data-sharing committee. Approved researchers must adhere to ethical and security guidelines, ensuring proper data use in compliance with applicable laws and regulations.

Publications

  • National Institutes of Health. National Institutes of Health State-of-the-Science Conference statement: management of menopause-related symptoms. Ann Intern Med. 2005 Jun 21;142(12 Pt 1):1003-13. Epub 2005 May 27. No abstract available.

    PubMed 15968015

  • Anderson GL, Limacher M, Assaf AR, Bassford T, Beresford SA, Black H, Bonds D, Brunner R, Brzyski R, Caan B, Chlebowski R, Curb D, Gass M, Hays J, Heiss G, Hendrix S, Howard BV, Hsia J, Hubbell A, Jackson R, Johnson KC, Judd H, Kotchen JM, Kuller L, LaCroix AZ, Lane D, Langer RD, Lasser N, Lewis CE, Manson J, Margolis K, Ockene J, O'Sullivan MJ, Phillips L, Prentice RL, Ritenbaugh C, Robbins J, Rossouw JE, Sarto G, Stefanick ML, Van Horn L, Wactawski-Wende J, Wallace R, Wassertheil-Smoller S; Women's Health Initiative Steering Committee. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial. JAMA. 2004 Apr 14;291(14):1701-12. doi: 10.1001/jama.291.14.1701.

    PubMed 15082697

  • Avis NE, Stellato R, Crawford S, Bromberger J, Ganz P, Cain V, Kagawa-Singer M. Is there a menopausal syndrome? Menopausal status and symptoms across racial/ethnic groups. Soc Sci Med. 2001 Feb;52(3):345-56. doi: 10.1016/s0277-9536(00)00147-7.

    PubMed 11330770

  • Appling S, Paez K, Allen J. Ethnicity and vasomotor symptoms in postmenopausal women. J Womens Health (Larchmt). 2007 Oct;16(8):1130-8. doi: 10.1089/jwh.2006.0033.

    PubMed 17937565

  • Freeman EW, Sherif K. Prevalence of hot flushes and night sweats around the world: a systematic review. Climacteric. 2007 Jun;10(3):197-214. doi: 10.1080/13697130601181486.

    PubMed 17487647

  • 35. NCT02475447, Safety, Pharmacokinetics and Preliminary Efficacy of Asimadoline in Pruritus Associated With Atopic Dermatitis. 2017, Tioga Pharmaceuticals: https://clinicaltrials.gov.

  • Mangel AW, Hicks GA. Asimadoline and its potential for the treatment of diarrhea-predominant irritable bowel syndrome: a review. Clin Exp Gastroenterol. 2012;5:1-10. doi: 10.2147/CEG.S23274. Epub 2012 Jan 12.

    PubMed 22346361

  • Wakabayashi Y, Nakada T, Murata K, Ohkura S, Mogi K, Navarro VM, Clifton DK, Mori Y, Tsukamura H, Maeda K, Steiner RA, Okamura H. Neurokinin B and dynorphin A in kisspeptin neurons of the arcuate nucleus participate in generation of periodic oscillation of neural activity driving pulsatile gonadotropin-releasing hormone secretion in the goat. J Neurosci. 2010 Feb 24;30(8):3124-32. doi: 10.1523/JNEUROSCI.5848-09.2010.

    PubMed 20181609

  • Trower M, Anderson RA, Ballantyne E, Joffe H, Kerr M, Pawsey S. Effects of NT-814, a dual neurokinin 1 and 3 receptor antagonist, on vasomotor symptoms in postmenopausal women: a placebo-controlled, randomized trial. Menopause. 2020 May;27(5):498-505. doi: 10.1097/GME.0000000000001500.

    PubMed 32068688

  • Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, Thurston RC, English M, Franklin C, Lee M, Neal-Perry G. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091-1102. doi: 10.1016/S0140-6736(23)00085-5. Epub 2023 Mar 13.

    PubMed 36924778

  • Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, Thurston RC, Wolfman W, English M, Franklin C, Lee M, Santoro N. Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981-1997. doi: 10.1210/clinem/dgad058.

    PubMed 36734148

  • Prague JK, Roberts RE, Comninos AN, Clarke S, Jayasena CN, Nash Z, Doyle C, Papadopoulou DA, Bloom SR, Mohideen P, Panay N, Hunter MS, Veldhuis JD, Webber LC, Huson L, Dhillo WS. Neurokinin 3 receptor antagonism as a novel treatment for menopausal hot flushes: a phase 2, randomised, double-blind, placebo-controlled trial. Lancet. 2017 May 6;389(10081):1809-1820. doi: 10.1016/S0140-6736(17)30823-1. Epub 2017 Apr 3.

    PubMed 28385352

  • Rance NE, Dacks PA, Mittelman-Smith MA, Romanovsky AA, Krajewski-Hall SJ. Modulation of body temperature and LH secretion by hypothalamic KNDy (kisspeptin, neurokinin B and dynorphin) neurons: a novel hypothesis on the mechanism of hot flushes. Front Neuroendocrinol. 2013 Aug;34(3):211-27. doi: 10.1016/j.yfrne.2013.07.003. Epub 2013 Jul 17.

    PubMed 23872331

  • Oakley AE, Steiner RA, Chavkin C, Clifton DK, Ferrara LK, Reed SD. kappa Agonists as a novel therapy for menopausal hot flashes. Menopause. 2015 Dec;22(12):1328-34. doi: 10.1097/GME.0000000000000476.

    PubMed 25988798

  • 26. FDA, BRISDELLE (paroxetine mesylate) NDA 204516 Approval Letter. U.S. Food and Drug Administration, Center for Drug Evaluation and Research, 2013.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Asimadoline in people with Vasomotor Symptoms, run by Tioga Pharmaceuticals at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Standish Fleming, CEO, MBA ((858) 245-7563, fleming@tiogapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety as Assessed by Adverse Events, Clinical Laboratory Parameters, and Vital Signs (time frame: baseline to 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07042516, which also lists 39 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.

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