S-pindolol benzoate (ACM-001.1)

S-pindolol has been described as an anabolic/catabolic transforming agent1. A clinical development programme for a new salt of S-pindolol (ACM.001.1) is underway with a Pharmacokinetic and Pharmacodynamic (PKPD) study which was initiated in December 2021. 

A Phase 2b/3 clinical development programme is in planning to confirm and expand upon the positive results demonstrated in a proof of concept Phase 2a trial, ACT-ONE2.


Mode of action

S-pindolol (ACM-001) is an anabolic/catabolic transforming agent with a multifunctional effect on three key pharmacological targets relevant for cancer cachexia:

  Reduction of catabolism by β-1receptor antagonism3,4,5

•  Increased anabolism and muscle growth, through partial β2 receptor agonism1

  Improvement in appetite and fatigue via central 5-HT1a antagonism6,7,8,9,10,11

This trio of anti-catabolic and pro-anabolic pharmacology makes S-pindolol (ACM-001) a unique candidate for development in cancer cachexia.

Clinical data

The ACT-ONE Phase II clinical study of S-pindolol (ACM-001) was a proof of concept exploratory, randomised, double-blind, placebo-controlled study in 87 patients with NSCLC (non-small-cell lung cancer) or colorectal cancer (CRC). The trial demonstrated that S-pindolol (ACM-001) was well-tolerated and that patients receiving high-dose S-pindolol (ACM-001) showed a median weight gain of 2.74kg compared to a median 1.09kg weight loss in patients receiving placebo over a 4-month period2.

Patients receiving S-pindolol (ACM-001) also demonstrated improved hand-grip strength.

Actimed initiated a pharmacokinetics and pharmacodynamics (PK/PD) study in December 2021 for S-pindolol benzoate (ACM-001.1). The study is being conducted in healthy subjects in two parts. It will compare S-pindolol benzoate to pindolol and will investigate PK across a range of doses of S-pindolol benzoate. This study will profile S-pindolol benzoate and is a prelude to the Phase 2b/3 clinical programme in patients with cancer cachexia which is in planning.


UK Patent

In May 2022, Actimed obtained a new UK patent (GB 2593902 B) covering new salts of S-pindolol for use in the treatment or prevention of cachexia with an expiry date in 2040. 

Additionally, an international patent application has been filed under the Patent Cooperation Treaty (PCT) and was published in October 2021, which seeks to extend patent protection for new S-pindolol salts to all relevant major international markets out to 2041.




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2A Coats et al Espindolol for treatment and prevention of cachexia: the ACT-ONE trial. J Cachexia Sarcopenia Muscle 2016; 7: 355–365

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