New Experimental Drug ABCL635 Cuts Menopause Hot Flashes by 83%

ABCL635 is an experimental non-hormonal drug designed to target NK3R and reduce menopause hot flashes

A new experimental drug for menopause hot flashes has produced a substantial reduction in symptoms in a mid-stage clinical trial.
Called ABCL635, the non-hormonal antibody was associated with an 83% reduction in moderate-to-severe hot flash frequency after four weeks, compared with 33% with placebo.

Women receiving the drug experienced an average of 8.8 fewer hot flashes per day from baseline, compared with 3.5 fewer episodes with placebo (1^✔ ✔Trusted Source
Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause

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However, it is important to note that ABCL635 is not available in the market. It is an experimental medicine still being evaluated in clinical trials and has not been approved for routine treatment of menopause symptoms. The 83% result is a top-line finding reported by the drug’s developer and has not yet appeared in a peer-reviewed clinical journal (1^✔ ✔Trusted Source
Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause

Go to source).

How Much Did the New Menopause Drug Reduce Hot Flashes?

ABCL635 is being studied in a randomized, double-blind, placebo-controlled Phase 1/2 clinical trial. The Phase 2 portion evaluated postmenopausal women aged 40 to 75 years with moderate-to-severe vasomotor symptoms, the medical term for hot flashes and related symptoms (1^✔ ✔Trusted Source
Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause

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).

The Phase 2 results reported by the developer included 92 participants who received either a single 600-mg subcutaneous injection of ABCL635 or placebo. After four weeks, hot flash frequency had decreased by 83% from baseline in the ABCL635 group, compared with 33% in the placebo group (1^✔ ✔Trusted Source
Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause

Go to source).

The reported reduction in hot flash severity was 58% with ABCL635 compared with 12% with placebo. Improvements were also reported in sleep and participants’ overall assessment of their improvement (1^✔ ✔Trusted Source
Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause

Go to source).

These figures describe the change seen during the trial. They do not prove that every woman with menopause will experience the same response, and they do not establish the drug’s long-term effectiveness.

How Does ABCL635 Work for Menopause Hot Flashes?

ABCL635 is designed to target the neurokinin 3 receptor, or NK3R. NK3R is part of a signaling system involving KNDy neurons in the hypothalamus, an area of the brain involved in temperature regulation (1^✔ ✔Trusted Source
Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause

Go to source

)(2^✔ ✔Trusted Source
Systematic review of neurokinin-3 receptor antagonists for the management of vasomotor symptoms of menopause

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).

During menopause, changes in estrogen signaling can affect this temperature-control pathway. Neurokinin B can activate KNDy neurons through NK3R, contributing to the processes involved in hot flashes. Research into NK3R-targeting medicines has therefore identified this pathway as a potential non-hormonal approach to treating vasomotor symptoms (2^✔ ✔Trusted Source
Systematic review of neurokinin-3 receptor antagonists for the management of vasomotor symptoms of menopause

Go to source).

ABCL635 is an antibody designed to block NK3R. However, the biological rationale for targeting NK3R should not be confused with proof that ABCL635 itself will provide a particular clinical benefit. Its effectiveness and safety still need to be established through further clinical testing.

What Do the ABCL635 Trial Results Show?

The most important limitation is that the newly reported efficacy data are top-line results from the drug developer. They have not yet undergone the full peer-review and publication process. That means independent researchers have not yet had the opportunity to examine the complete dataset in a scientific journal (1^✔ ✔Trusted Source
Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause

Go to source

).

The trial itself remains an ongoing clinical development program. ClinicalTrials.gov lists the study as an interventional Phase 1/2 trial sponsored by AbCellera, with an estimated overall enrollment of 136 participants and an estimated study completion in February 2027 (1^✔ ✔Trusted Source
Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause

Go to source).

Is ABCL635 Available in the Market?

No. ABCL635 is not currently available in the market.

This is an experimental menopause drug, not an approved medicine. It is being studied in clinical trials to determine whether its potential benefits outweigh its risks (1^✔ ✔Trusted Source
Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause

Go to source).

The distinction matters. A positive Phase 2 result does not mean that a drug can immediately be prescribed or purchased. Further clinical development, longer follow-up and regulatory assessment are needed before a new medicine can be considered for routine use.

People should therefore not try to obtain ABCL635 outside an authorized clinical trial or replace an existing menopause treatment with it.

What Should Women Know About New Menopause Treatments?

Menopause symptoms can be persistent and disruptive. Research from the Study of Women’s Health Across the Nation found that frequent vasomotor symptoms lasted a median of 7.4 years, continuing for 4.5 years after the final menstrual period in women with an observable final period (3^✔ ✔Trusted Source
Duration of menopausal vasomotor symptoms over the menopause transition

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).

That long duration helps explain why researchers continue to look for treatments that can control hot flashes while offering different options for women who cannot use, or do not want, hormone therapy.

For women dealing with troublesome hot flashes, the practical message is straightforward: new treatments are being developed, but ABCL635 is not yet one that can be prescribed from a pharmacy. Established treatment options should be discussed with a healthcare professional based on symptoms, medical history and individual risks.

What you can do now:

• Discuss frequent or severe hot flashes with a healthcare professional rather than self-treating based on online claims
• Ask about established hormonal and non-hormonal treatment options that are appropriate for your health history
• Do not buy or use ABCL635 outside an authorized clinical trial
• Follow future clinical research on ABCL635 for longer-term effectiveness and safety data

The ABCL635 results add another potential direction to menopause research, but they are best viewed as an early clinical signal rather than a finished treatment story. For now, women have established options for managing hot flashes, while research into newer non-hormonal approaches continues.

References:

1. Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause
   – (https://clinicaltrials.gov/study/NCT07118891)
2. Systematic review of neurokinin-3 receptor antagonists for the management of vasomotor symptoms of menopause
   – (https://pubmed.ncbi.nlm.nih.gov/38471077/)
3. Duration of menopausal vasomotor symptoms over the menopause transition
   – (https://pubmed.ncbi.nlm.nih.gov/25686030/)

Source-Medindia