Last update 06 Jan 2025

Pindolol

Last update 06 Jan 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

1-(1H-indol-4-yloxy)-3-(isopropylamino)propan-2-ol, 1-(1H-indol-4-yloxy)-3-(propan-2-ylamino)-propan-2-ol, 1-(1H-indol-4-yloxy)-3-[(1-methylethyl)amino]propan-2-ol

+ [8]

Target

β-adrenoceptors

Mechanism

β-adrenoceptors antagonists(Beta adrenergic receptors antagonists)

Therapeutic Areas

Nervous System DiseasesCardiovascular DiseasesOther Diseases

Active Indication

Arrhythmias, CardiacHypertensionAngina Pectoris+ [2]

Inactive Indication-

Originator Organization

Alfresa Pharma Corp.

Active Organization

Nichi-Iko Pharmaceutical Co., Ltd.

Alfresa Pharma Corp.

Inactive Organization

Novartis Pharmaceuticals Corp.

Drug Highest PhaseApproved

First Approval Date

JP (26 Aug 1972),

Tachycardia, Sinus

Regulation-

Structure

Molecular FormulaC14H20N2O2

InChIKeyJZQKKSLKJUAGIC-UHFFFAOYSA-N

CAS Registry13523-86-9

Clinical Trials associated with Pindolol

NCT06028321 / CompletedPhase 1

Two Part Study to Assess Comparative Bioavailability, Pharmacokinetics of a Single Dose of ACM-001.1, Two Single Doses of Pindolol (Part1) Followed by Evaluation of Steady State Pharmacokinetics, Pharmacodynamics of ACM-001.1 in HV (Part2)

The aim of this early phase two-part study was to compare the bioavailability (BA) pharmacokinetics (PK) and pharmacodynamics (PD) of racemic pindolol with the benzoate salt of the S-enantiomer of pindolol (ACM-001.1) and provide safety information. A total of 51 healthy male and female subjects were enrolled, and 48 healthy subjects completed the study.
Part 1 consisted of two Groups to compare BA and PK, Group 1 received two treatment sequences of a single dose of ACM-001.1 versus racemic pindolol; Group 2 ran in parallel with Group 1 and assessed the PK of a single dose of racemic pindolol in a single period.
Part 2 consisted of four groups, to evaluate the steady state PK and PD of ACM-001.1 with multiple ascending doses over 4 days.

Start Date26 Nov 2021

Sponsor / Collaborator

Actimed Therapeutics Ltd.Startup

[+1]

NCT01950520 / CompletedPhase 2IIT

The Mechanism of Human Non-Shivering Thermogenesis and Basal Metabolic Rate

Background:
- Changes in how a person's body burns energy or calories can affect their weight over time. The lowest level of energy the body needs to function is called basal metabolic rate. In the cold, we burn extra energy, even before we start to shiver. This is called non-shivering thermogenesis and it occurs in different types of tissue such as muscle and fat. Researchers want to learn more about this type of energy burning and how it is regulated. They hope this will help treat obesity in the future.
Objectives:
* Sub-study 1: to better understand how non-shivering thermogenesis works.
* Sub-study 2: to measure the effects of anti-obesity drugs on basal metabolic rate.
* Sub-study 3: to better understand the effects of mirabegron, a beta-3 adrenergic receptor agonist, on brown fat activity.
Eligibility:
- Healthy, lean adult males ages 18 to 35.
Design:
* Participants will be screened with medical history, physical exam, blood test, and EKG.
* For sub-studies 1 and 2:
* Participants will receive one X-ray scan.
* Each day, all participants will:
* Have height and weight measured, and have urine collected.
* Spend 4 hours in a temperature-controlled room with furniture, toilet area, phone, and computer. They will wear small non-invasive devices to monitor activity, heart rate, temperature, and shivering.
* Walk for 30 minutes.
* For sub-study 3:
* Participants will receive one DXA scan and up to 4 PET/CT scans and 4 MRIs
* Each stay, all participants will:
* Have height and weight measured, and have urine collected.
* Spend 6 hours in a temperature-controlled room with furniture, toilet area, phone, and computer. They will wear small non-invasive devices to monitor activity, heart rate, temperature, and shivering.
* Participants will be compensated for their time and participation at the end of the study

Start Date07 Feb 2014

Sponsor / Collaborator

National Institute of Diabetes & Digestive & Kidney Diseases

NCT01778686 / CompletedNot ApplicableIIT

Evaluation of [11C]Cimbi-36 as an Agonist PET Radioligand for Imaging of 5-HT2A Receptors

The serotonin 2A (5-HT2A) receptor is the most abundant excitatory serotonin (5-HT, 5-hydroxytryptamine) receptor in the human brain, and multiple positron emission tomography (PET) studies have investigated the 5-HT2A receptors in the human brain using antagonist radioligands. However, the currently available antagonist PET radioligands bind the total pool of 5-HT2A receptor receptors whereas a 5-HT2A receptor agonist binds the high-affinity subgroup of the receptors which are also G-protein coupled, and thus hypothesized to be the functional relevant population of receptors. At the Center for Integrated Molecular Brain Imaging (CIMBI), a novel agonist PET radioligands for brain imaging of 5-HT2A receptors was recently validated in animals (Ettrup et al. 2011, EJNMMI). In the human brain, [11C]Cimbi-36 was validated as a selective 5-HT2A receptor agonist PET radioligand through a blocking study with the 5-HT2A receptor antagonist pharmaceutical ketanserin. In this validation study, the biodistribution and kinetic modelling of [11C]Cimbi-36 binding in the human brain was also validated. With these studies, investigators will test the most promising of these, [11C]Cimbi-36, in clinical trials, where it will provide a novel method for detecting dysfunction in the 5-HT system. The specific aim of this clinical trial is:
- To examine the effect of acute alterations in 5-HT levels on cerebral [11C]Cimbi-36 binding in healthy volunteers who will be PET-scanned at baseline and after pharmacological or dietary interventions that either increase or decrease cerebral 5-HT levels.
It is hypothesized that this novel agonist radioligand will provide both a more physiological relevant measure of the 5-HT2A receptors and also reflect levels of cerebral 5-HT in humans, more specifically:
BP will decrease after pindolol and selective serotonin reuptake inhibitor (SSRI) treatment and increase after acute tryptophan depletion (ATD). Placebo will leave binding potential (BP) unchanged.

Start Date01 Jan 2013

Sponsor / Collaborator

Rigshospitalet

100 Clinical Results associated with Pindolol

100 Translational Medicine associated with Pindolol

100 Patents (Medical) associated with Pindolol

2,972

Literatures (Medical) associated with Pindolol

01 Feb 2025·Journal of Cachexia Sarcopenia and Muscle

Pharmacokinetics, Pharmacodynamics and Bioavailability of ACM‐001.1 (S‐Pindolol Benzoate) in Healthy Volunteers

Article

Author: Whitaker, Gareth ; Wohlfeil, Stefan ; Henderson, Dennis ; Morten, Elaine ; McDermott, John ; Menakuru, Somasekhara R. ; Misselwitz, Frank ; Roe, Chris

ABSTRACT:

Background:

S‐pindolol has metabolic effects of potential benefit in cancer cachexia: reduced catabolism through nonselective β‐blockade; increased anabolism through partial β2 receptor agonism; and increased appetite and reduced fatigue through central 5‐hydroxytryptamine/serotonin receptor activity. A Phase 2a clinical trial demonstrated that S‐pindolol can reverse weight loss and improve fat‐free mass in patients with cancer‐related weight loss. A comparative phase I bioavailability study of S‐pindolol and racemic pindolol was performed to support the development of S‐pindolol in cancer cachexia.

Methods:

This two‐part study assessed the comparative bioavailability and pharmacokinetics of single doses of S‐pindolol benzoate (ACM‐001.1) or pindolol (Part 1) and the steady‐state pharmacokinetics and pharmacodynamics of multiple doses of ACM‐001.1 and pindolol (Part 2) in healthy volunteers (NCT06028321). ACM‐001.1 5, 10 and 15 mg and pindolol 15, 20 and 30 mg were tested. In Part 1, subjects were randomised to ACM‐001.1 15 mg followed after a 48‐h washout period by pindolol 30 mg, or the reverse sequence; another group received pindolol 15 mg. Subjects in Part 2 were randomised to pindolol 20 mg twice‐daily or ACM‐001.1 5, 10 or 15 mg twice‐daily for 4 days. Bioavailability, pharmacokinetics, pharmacodynamics, potential for and extent of stereoconversion, and tolerability were assessed.

Results:

Parts 1 and 2 included 24 and 27 healthy volunteers, respectively. ACM‐001.1 had predictable pharmacokinetics up to a dose of 15 mg twice daily, with low intersubject variability, after single and multiple doses (Tmax 1 vs. 1.5 h; Cmax 74 vs. 73.6 ng/mL; AUC(0−t) 440 vs. 414 ng·h/mL; t1/2 4.042 vs. 3.566 h). The bioavailability of S‐pindolol after equivalent doses of pindolol (20 mg) and ACM‐001.1 (10 mg) was comparable, and formal bioequivalence margins were met (90% CI for Cmax, AUC(0−t) and AUC(0–inf) within 80%–125% bioequivalence acceptance criteria). No evidence of stereoconversion of the S‐enantiomer into the R‐enantiomer, no accumulation, dose linearity and dose proportionality of S‐pindolol over a range of doses were demonstrated; we also show indirectly that there was no food effect. ACM‐001.1 was generally well tolerated, with no apparent relationship of side effects to dose, no serious adverse events, severe treatment‐emergent adverse events (TEAEs) or deaths, and similar incidences of TEAEs (fatigue, dizziness, somnolence, nausea and headache) with ACM‐001.1 10 and 15 mg and pindolol 20 mg.

Conclusions:

Data from this bridging study of enantiomerically pure ACM‐001.1 and its parent racemic drug, pindolol, support clinical trials of ACM‐001.1 for the treatment of cancer cachexia.

01 Nov 2024·Heliyon

Machine learning in obsessive-compulsive disorder medications

Article

Author: Mehrabani, Mitra ; Sabahi, Abdolreza ; Bakhshinejad, Behnaz ; Shafiee, Mehdi ; Rukerd, Mohammad Rezaei Zadeh ; Jafarzadeh, Abdollah ; Khazaneha, Mahdiyeh ; Nakhaie, Mohsen ; Khaksari, Mohammad ; Mehrbani, Mehrzad

Obsessive-compulsive disorder (OCD) is the fourth most common psychiatric disorder with a significant morbidity rate. Despite various treatment modalities and medications, some patients show no definitive response. The aim of this study is to classify the medications of OCD with machine learning (ML) methods and to compare the classification performances of the decision tree (DT), chi-square automatic interaction detection (CHAID) algorithm, and linear model in ML methods. This research is a descriptive analytical study based on co-word and artificial intelligence methods. The DT models were created with a target (total weight link strength). For hyperparameter optimization, the Gini index was used as the weight total link strength. The performance of the DT model was evaluated based on the prediction model. A total of 116 drugs were extracted from 6574 articles based on co-word analysis, and 56 drugs were classified as the DT's root. These drugs were categorized into six groups in the EWKM diagram. The DT was constructed using the weight.total.link index, with 7 items in Label 3 and 42 items in Label 5 serving as DT leaves. The ML analysis provided valuable insights into the efficacy of various medications such as clomipramine, duloxetine, and pindolol, as well as supplements such as folate, in the treatment of OCD. Treating concomitant diseases, namely hypothyroidism and streptococcal infection could improve the efficacy of treatment.

01 Nov 2024·SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY

The molecular structure, vibrational spectra, solvation effect, non-covalent interactions investigations of psilocin

Article

Author: Raja, Murugesan ; Issaoui, Noureddine ; Holikulov, Utkirjon ; Kazachenko, Aleksandr S ; Al-Dossary, Omar M ; Kazachenko, Anna S ; Xiang, Zhouyang

Psilocin, or 4-HO-DMT (or 3-(2-dimethylaminoethyl)-1H-indol-4-ol), is a psychoactive alkaloid substance from the tryptamine family, isolated from Psilocybe mushrooms. This substance is being studied by various research groups because it has a clear therapeutic effect in certain dosages. In this work, the study of the structure and properties of psilocin was carried using theoretical methods: the effects of polar solvents (acetonitrile, dimethylsulfoxide, water, and tetrahydrofuran) on the structural parameters, spectroscopic properties (Raman, IR, and UV-Vis), frontier molecular orbital (FMO), molecular electrostatic potential (MEP) surface, and nonlinear optical parameters (NLO). Theoretical calculations were performed at the B3LYP/6-311++G(d,p) level by the density functional theory (DFT) method. IEFPCM was used to account for solvent effects. The types and nature of non-covalent interactions (NCI) between psilocin and solvent molecules were determined using Atoms in Molecules (AIM), the reduced density gradient method (RDG), the electron localization function (ELF), and the localization orbital locator (LOL). Experimental and calculated FT-IR, FT-Raman, and UV-Vis spectra were compared and found to be in good agreement.

News (Medical) associated with Pindolol

13 Dec 2024

·www.globenewswire.com

Actimed Therapeutics Announces Publication of Successful S-pindolol benzoate (ACM-001.1) Phase 1 Study in The Journal of Cachexia, Sarcopenia and Muscle

London, UK – 13th December 2024. Actimed Therapeutics Ltd (“Actimed”), a UK based clinical stage speciality pharmaceutical company focused on bringing innovation to the treatment of cancer cachexia and other muscle wasting disorders, announces that results from its Phase 1 pharmacokinetic (PK), pharmacodynamic (PD) and bioavailability study of S-pindolol benzoate (ACM-001.1) in healthy volunteers (NCT06028321) have been published in The Journal of Cachexia, Sarcopenia and Muscle. This was a two-stage Phase I study. The first stage assessed the comparative bioavailability and pharmacokinetics of a single dose of S-pindolol benzoate and two single doses of racemic pindolol. The second stage evaluated the steady-state pharmacokinetics and pharmacodynamics of multiple doses of S-pindolol benzoate in healthy volunteers. The study met all pre-defined endpoints, demonstrating that S-pindolol benzoate has predictable pharmacokinetics up to a dose of 15 mg twice daily, with low inter-subject variability after single and multiple doses. Moreover, bioavailability of S-pindolol after equivalent doses of racemic pindolol and S-pindolol benzoate was comparable, and although not a prespecified objective, formal bioequivalence margins were met. The study also showed: An absence of in vivo stereo-conversion of S-pindolol into R-pindololDose linearity and dose proportionality of S-pindolol benzoate over a wide range of doses S-pindolol benzoate was generally well tolerated A lack of food effect with S-pindolol benzoate - and an important consideration for use in cancer patients who have a high incidence of appetite loss Robin Bhattacherjee, Chief Executive Officer of Actimed Therapeutics commented “The anti-catabolic and pro-anabolic pharmacology of our lead compound S-pindolol benzoate position it as a novel and promising new therapy for cancer cachexia. These data demonstrate that S-pindolol benzoate is essentially bioequivalent to the S-pindolol present in racemic pindolol and provide strong support for the further clinical development of S-pindolol benzoate for the treatment of cancer cachexia and potentially other conditions associated with muscle wasting”. The publication may be accessed here: https://doi-org.libproxy1.nus.edu.sg/10.1002/jcsm.13651 *** About Actimed Therapeutics Actimed Therapeutics is a clinical stage speciality pharmaceutical company focused on bringing innovation to the treatment of muscle wasting disorders to transform the care of an underserved and vulnerable patient population. The lead area of focus for Actimed is specifically in cachexia. Cachexia is a wasting disease that is associated with cancer and other serious chronic illnesses and with significant morbidity and mortality. A significant number of cancer patients suffer from cachexia1 and it is estimated that cachexia is responsible for up to 20% of all cancer deaths2. A recent meta-analysis demonstrated that cachexia was associated with an 82% higher relative risk of mortality in patients with NSCLC versus no cachexia3. Despite its prevalence and devastating clinical effects, there is no globally approved drug for the treatment or prevention of cancer-related cachexia. The lead product of Actimed, S-pindolol benzoate (ACM-001.1) targets multiple pathways that drive cachexia and has generated promising proof of concept Phase 2a clinical data in cachexia patients. Actimed is currently preparing for further clinical studies in cancer cachexia having received an Investigational New Drug (IND) approval from FDA for S-pindolol benzoate in August 2023 for the treatment of cancer cachexia. Actimed also owns the global rights to its second asset, S-oxprenolol ACM-002), which is being developed by the Company for the muscle wasting seen in amyotrophic lateral sclerosis (ALS) where loss of body mass and muscle wasting may impact survival⁴. Actimed was granted Orphan Drug Designation to S-oxprenolol for the treatment of ALS by the FDA in 2024. Actimed has licensed the global rights to develop and commercialise S-oxprenolol for cancer cachexia and any other indications outside of ALS to US company Faraday Pharmaceuticals. FOR MORE INFORMATIONActimed Therapeuticswww.actimedtherapeutics.com MEDiSTRAVA Frazer Hall, Erica HollingsworthTel: +44 (0)203 928 6900Email: actimed@medistrava.com ___________________________[1] Anker M et al., J. Cachexia, Sarcopenia and Muscle; 2019: 10: 22 – 242 Argilés JM et al, Nat Rev Cancer 2014; 14:754-623 Bonomi P. et al. The mortality burden of cachexia in patients with non-small-cell lung cancer: A meta-analysis; International Conference of Sarcopenia, Cachexia and Wasting Disorders, June 17 – 18 2023, Stockholm, abstract 2-18, page 139⁴ Wolf J et al., PMID 28184974 DOI: 10.1007/s00115-117-0293

Phase 1Orphan DrugClinical ResultDrug ApprovalPhase 2

08 Sep 2023

·www.globenewswire.com

Actimed Therapeutics announces FDA approval of its Investigational New Drug application for Phase 2b/3 IMPACT clinical trials of S-pindolol benzoate to treat cancer cachexia

First Investigational New Drug (IND) approval for Actimed - a significant corporate milestone Approval granted for the IMPACT programme – IMProving cancer cachexia with ACTAs (Anabolic/Catabolic Transforming Agents): one study treating cachexia associated with colorectal cancer (CRC) and another in non-small cell lung cancer (NSCLC) Actimed to initiate this international clinical development programme for S-pindolol benzoate in cancer cachexia, pending completion of Series B financing, and plans to dose first patient in 2024 Actimed Therapeutics Ltd (“Actimed”), a UK based clinical stage specialty pharmaceutical company focused on bringing innovation to the treatment of cancer cachexia and other muscle wasting disorders, today announces that it has received approval from the US FDA for its IND application for one Phase 2b/3 clinical study of S-pindolol benzoate (the “IMPACT” clinical trial programme) to treat cachexia associated with colorectal cancer (IMPACT CRC) and another in patients with non-small cell lung cancer (IMPACT NSCLC). Cachexia has long been recognised as a secondary disease to cancer can lead to up to 20% of cancer deaths. Despite this, weight loss in patients with cancer is rarely assessed or managed actively. Other than supportive care, no globally approved products are available for this patient population so there remains an important unmet need for effective new treatments. S-pindolol has demonstrated promising results in a Phase 2a, proof of concept trial, the ACT-ONE trial¹, and Actimed has successfully completed a pharmacokinetic/pharmacodynamic (PK/PD) study with S-pindolol benzoate (ACM-001.1) that met all pre-defined objectives. These included demonstrating an absence of in vivo stereo-conversion (from S-pindolol to R-pindolol) and demonstrating that S-pindolol benzoate is essentially bioequivalent to the S-pindolol present in racemic pindolol with dose-proportional and dose-dependent pharmacokinetics after single and multiple doses. The anti-catabolic and pro-anabolic pharmacology of S-pindolol benzoate position it as a novel and promising new therapy for cancer cachexia. Actimed has designed the Phase 2b/3 IMPACT clinical trials programme to allow a full evaluation of the safety and efficacy of S-pindolol benzoate, with plans to dose the first trial participant in 2024. Jose Garcia MD, PhD, Professor of Medicine at the University of Washington School of Medicine, Director of the Geriatric Research Educational and Clinical Centre (GRECC) at the Puget Sound Veterans Affairs Healthcare System, and US Principal Investigator for the IMPACT trial programme commented “Despite the advances in cancer treatment over recent years, there are few treatment options and no new globally approved products for treating cancer cachexia. This places a tremendous burden on patients, their caregivers and families and can have a direct impact on mortality. I am therefore very pleased to be leading the IMPACT US clinical trial programme for this potential new treatment in this area of high unmet need”. Elaine Morten PhD, Head of Regulatory Affairs and Technical Development for Actimed Therapeutics commented “Approval of our first IND application is a significant corporate milestone for Actimed and will allow us to begin the critical next phase of our planned clinical studies for our lead compound, S-pindolol benzoate. It is our intention to obtain further clinical trial approvals in other major territories so that, with the necessary funding, we can complete the IMPACT studies as expeditiously as possible”. Earlier this year, Actimed commenced the preparations to formally launch its Series B financing round which is designed to fund the IMPACT clinical programme to completion. WG Partners, a London-based Life Sciences specialist advisory firm, is assisting Actimed in the Series B financing which is now well advanced. About Actimed Therapeutics Actimed Therapeutics is a clinical stage specialty pharmaceutical company focused on bringing innovation to the treatment of muscle wasting disorders to transform the care of an underserved and vulnerable patient population. Actimed was founded in 2017 by Stefan Anker and Andrew Coats, two eminent physicians in muscle wasting research, together with Yann Colardelle, a professional in communications and medical education who has been involved in research and education in cachexia for many years. The lead area of focus for Actimed is specifically in cachexia. Cachexia is a wasting disease that is associated with cancer and other serious chronic illnesses and with significant morbidity and mortality. A significant number of cancer patients suffer from cachexia² and it is estimated that cachexia is responsible for up to 20% of all cancer deaths³. A 2023 meta-analysis demonstrated that cachexia was associated with an 82% higher relative risk of mortality in patients with non-small cell lung cancer (NSCLC) versus no cachexia⁴. Despite its prevalence and devastating clinical effects, there is no globally approved drug for the treatment or prevention of cancer-related cachexia. The lead product of Actimed, S-pindolol benzoate (ACM-001.1) targets multiple pathways that drive cachexia and has generated promising proof of concept Phase 2a clinical data in cachexia patients. Actimed has received Investigational New Drug (IND) approval for its planned phase 2b/3 clinical studies (IMPACT programme) in cachexia in NSCLC and colorectal cancer (CRC). Actimed also owns the global rights to its second asset, S-oxprenolol, which is being developed by the Company for the muscle wasting seen in amyotrophic lateral sclerosis (ALS) where loss of body mass and muscle wasting may impact survival5. Actimed has licensed the global rights to develop and commercialise S-oxprenolol for cancer cachexia and any other indications outside of ALS to US company Faraday Pharmaceuticals. ¹A Coats et al Espindolol for treatment and prevention of cachexia: the ACT-ONE trial. J Cachexia Sarcopenia Muscle 2016; 7: 355–365 ²Anker M et al., J. Cachexia, Sarcopenia and Muscle; 2019: 10: 22 – 24 ³Argilés JM et al, Nat Rev Cancer 2014; 14:754-62 ⁴Bonomi P. et al. The mortality burden of cachexia in patients with non-small-cell lung cancer: A meta-analysis; International Conference of Sarcopenia, Cachexia and Wasting Disorders, June 17 – 18 2023, Stockholm, abstract 2-18, page 139 ⁵Wolf J et al., PMID 28184974 DOI: 10.1007/s00115-117-0293 The content above comes from the network. if any infringement, please contact us to modify.

Phase 2Clinical ResultIND

14 Dec 2021

·actimedtherapeutics.com

Actimed Therapeutics Achieves Major Corporate Milestone – Initiation of first clinical study of new salt of S-pindolol (ACM-001.1)

Actimed Therapeutics initiates the company’s first clinical study of the pharmacokinetics and pharmacodynamics (PK/PD) for a new salt of S-pindolol (ACM-001.1) This study is a prelude to the commencement of a Phase 2b clinical programme in patients ACM-001.1 has the potential to become the first globally approved drug to treat cancer cachexia London, UK – 14 December 2021. Actimed Therapeutics Ltd announces that following regulatory approval from the UK Regulatory Agency, it has commenced a clinical study in healthy subjects to evaluate the PK and PD of its lead compound, ACM-001.1, a new salt of S-pindolol that is under development as a treatment for cancer cachexia. The study will be conducted in healthy subjects in two parts. It will compare ACM-001.1 to pindolol and will investigate both single and multiple dose PK and assess a range of doses of ACM-001.1. Data from the study are expected in the first half of 2022 and will be used to inform the Phase 2b programme which is planned for late 2022. Robin Bhattacherjee, Actimed CEO, commented: “This is an exciting time in the development of our new salt form of S-pindolol. We have worked hard on the development of this formulation over the last 2 years given the considerable benefits it delivers including improved stability, scalability for commercial manufacture and the potential for significantly extended patent life. The PK/PD study is a key clinical development milestone towards our ultimate aim of securing the first global approval for the treatment of cancer cachexia, a hugely under-served disease which is estimated to affect 50-80% of all cancer patients.” About Actimed Therapeutics Actimed Therapeutics is a clinical stage biopharmaceutical company focused on bringing innovation to the treatment of muscle wasting disorders to transform the care of an underserved and vulnerable patient population. Actimed was founded in 2017 by Stefan Anker and Andrew Coats, two world leading physicians in muscle wasting research. The lead area of focus for Actimed is specifically in cachexia. Cachexia is a wasting disease that accompanies cancer and other serious chronic illnesses and is associated with significant morbidity and mortality. Despite its prevalence and devastating clinical effects, there is no globally approved drug for the treatment or prevention of cancer-related cachexia. It has been estimated that cachexia affects 50–80% of cancer patients and accounts for up to 20% of cancer deaths. Treating cancer cachexia successfully may increase both the length and quality of life for cancer patients1. The lead product of Actimed, S-pindolol (ACM-001.1), is an anabolic/catabolic transforming agent2 (ACTA). In nonclinical models, S-pindolol has been shown to target multiple pathways that drive cachexia and has generated promising proof of concept Phase II clinical data in cachexia patients3. Actimed is currently preparing for further clinical studies in cachexia in Non-Small Cell Lung Cancer (NSCLC) and Colorectal Cancer (CRC). Actimed has licensed the global rights to develop and commercialise S-oxprenolol, the Company’s second product, for cancer cachexia and any other indications outside of amyotrophic lateral sclerosis (ALS) to Faraday Pharmaceuticals. Actimed retains global rights to S-oxprenolol in ALS, where loss of body mass and muscle wasting may impact survival. 1 Argiles JM, Busquets S, Stemmler B, Lopez-Soriano FJ. Cancer cachexia: understanding the molecular basis. Nat Rev Cancer. 2014;14:754–62. 2 Pötsch MS, et al. The anabolic catabolic transforming agent (ACTA) espindolol increases muscle mass and decreases fat mass in old rats. J Cachexia Sarcopenia Muscle. 2014 Jun;5(2):149-58 3 Coats AJS, et al. Espindolol for the treatment and prevention of cachexia: a randomized, double‐blind, placebo‐controlled, international multicentre phase II study (the ACT‐ONE trial). J Cachexia Sarcopenia Muscle 2016 Jun; 7(3):355-365.

Phase 2Clinical Result

100 Deals associated with Pindolol

External Link

KEGG	Wiki	ATC	Drug Bank
D00513	Pindolol	C07AA03	DB00960

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Arrhythmias, Cardiac	CN	-	01 Jan 1995
Hypertension	US	Novartis Pharmaceuticals Corp.	03 Sep 1982
Angina Pectoris	JP	Nichi-Iko Pharmaceutical Co., Ltd.	19 Jun 1980
Essential Hypertension	JP	Alfresa Pharma Corp.	31 Aug 1976
Tachycardia, Sinus	JP	Alfresa Pharma Corp.	26 Aug 1972

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01778686 (CTgov)	Not Applicable	-	24	Pindolol+Citalopram (Citalopram and Pindolol)	ezzgvnjqxk(ezoxawsbfj) = jhrvlwyhic qtilrstuun (pdrzbwkyzl, gnqksjxekg - qkovepgnym) View more	-	09 Oct 2024
				Placebo (Placebo)	ezzgvnjqxk(ezoxawsbfj) = dbujxxfkqy qtilrstuun (pdrzbwkyzl, kavsqlsuzk - ghyzojqrio) View more
NCT00931775 (Pubmed \| J Clin Psychiatry)	Phase 2	Reactive depression	30	Citalopram + Pindolol	hgvcebyupt(zirpoebowe) = ngldgdomza jefhrlwczj (arkljkxmhr )	Positive	01 Jul 2011
				Citalopram + Placebo	hgvcebyupt(zirpoebowe) = ofghovlbkt jefhrlwczj (arkljkxmhr )

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