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  • ||||||||||  pavinetant (AZD4901) / AstraZeneca, Tempest Therap
    Journal:  NK3 receptor antagonist alters the centrally controlled perception of menopausal flushing - a pilot study. (Pubmed Central) -  Mar 14, 2025   
    Using functional magnetic resonance imaging (fMRI), this study investigated the central effect of the NK3R antagonist MLE4901 during a flush, particularly functional connectivity changes in the salience network...This pilot study demonstrates decreased connectivity in the salience network during NK3R antagonist treatment. This may indicate areas of interest for further targeted fMRI studies and mechanistic investigation of this novel treatment for flushing.
  • ||||||||||  nevanimibe (ATR-101) / Tempest Therap
    Review, Journal:  Current and novel treatment strategies in children with congenital adrenal hyperplasia. (Pubmed Central) -  Dec 7, 2023   
    It is not known what levels of adrenal androgens are optimal for normal growth, puberty, and bone health. The basis of using glucocorticoids and mineralocorticoids in the treatment of CAH remains, and in some individuals, it may be beneficial to add therapies to reduce the androgen load during certain life stages.
  • ||||||||||  nevanimibe (ATR-101) / Millendo Therap
    Journal:  Molecular structures of human ACAT2 disclose mechanism for selective inhibition. (Pubmed Central) -  Mar 23, 2022   
    Here, we report cryogenic electron microscopy structures of human ACAT2 bound to its specific inhibitor pyripyropene A or the general ACAT inhibitor nevanimibe...Enzymatic assays show that mutations within sites of cholesterol entry or allosteric activation attenuate ACAT2 activity in vitro. Together, these results reveal mechanisms for ACAT2-mediated esterification of cholesterol, providing a blueprint to design new ACAT2 inhibitors for use in the prevention of cardiovascular disease.
  • ||||||||||  pavinetant (AZD4901) / AstraZeneca, Millendo Therap
    Preclinical, Journal:  Neurokinin 3 receptor antagonism ameliorates key metabolic features in a hyperandrogenic PCOS mouse model. (Pubmed Central) -  Oct 22, 2021   
    Treatment with a NK3R antagonist (MLE4901) did not impact the observed reproductive defects...NK3R antagonism did not improve circulating serum triglyceride or fasted glucose levels. Collectively, these findings demonstrate that NK3R antagonism may be beneficial in the treatment of adverse metabolic features associated with PCOS and support neuroendocrine targeting in the development of novel therapeutic strategies for PCOS.
  • ||||||||||  dexamethasone / Generic mfg., abiraterone acetate / Generic mfg.
    Clinical, Clinical data, Journal:  Clinical outcomes in 21-hydroxylase deficiency. (Pubmed Central) -  Sep 29, 2021   
    Negative consequencies are to large extent the result of the unphysiological glucocorticoid replacement. Modern management with improved follow-up and future addition of new drugs may improve outcomes.
  • ||||||||||  pavinetant (AZD4901) / AstraZeneca, Tempest Therap, NN1213 / Novo Nordisk
    Enrollment change:  Neuropeptide Treatment for Hot Flushes During the Menopause (clinicaltrials.gov) -  May 3, 2021   
    P2,  N=37, Completed, 
    The current review provides a summary of the available evidences from current and recent clinical trials on CD, with a specific focus on preliminary data. N=67 --> 37
  • ||||||||||  nevanimibe (ATR-101) / Tempest Therap
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date:  Nevanimibe HCl for the Treatment of Classic CAH (clinicaltrials.gov) -  Jul 16, 2020   
    P2,  N=15, Terminated, 
    No abstract available N=24 --> 15 | Trial completion date: Dec 2020 --> Jul 2020 | Recruiting --> Terminated | Trial primary completion date: Dec 2020 --> Jun 2020; Following an interim data review, further investment in nevanimibe has been discontinued
  • ||||||||||  nevanimibe (ATR-101) / Millendo Therap
    Journal:  Structure of nevanimibe-bound tetrameric human ACAT1. (Pubmed Central) -  Jul 1, 2020   
    Each monomer contains nine transmembrane helices (TMs), six of which (TM4-TM9) form a cavity that accommodates nevanimibe and an endogenous acyl-coenzyme A. This cavity also contains a histidine that has previously been identified as essential for catalytic activity. Our structural data and biochemical analyses provide a physical model to explain the process of cholesterol esterification, as well as details of the interaction between nevanimibe and ACAT1, which may help to accelerate the development of ACAT1 inhibitors to treat related diseases.
  • ||||||||||  Livoletide (AZP-531) / Millendo Therap, Jazz
    Trial completion date, Trial termination, Trial primary completion date:  ZEPHYR: Effects of Livoletide (AZP-531) on Food-related Behaviors in Patients With Prader-Willi Syndrome (clinicaltrials.gov) -  May 31, 2020   
    P2b,  N=158, Terminated, 
    These exposures are >100-fold above the anticipated clinical exposures in the Phase 2b/3 ZEPHYR study, which is enrolling people ages 4 to 65 with PWS. Trial completion date: Mar 2021 --> May 2020 | Active, not recruiting --> Terminated | Trial primary completion date: Jun 2020 --> Feb 2020; Livoletide did not result in a statistically significant improvement in hyperphagia and food-related behaviors
  • ||||||||||  pavinetant (AZD4901) / AstraZeneca, Millendo Therap
    Clinical, Journal:  Neurokinin 3 Receptor Antagonists Do Not Increase FSH or Estradiol Secretion in Menopausal Women. (Pubmed Central) -  Apr 23, 2020   
    P2
    Single-center, randomized, double-blind, placebo-controlled, crossover trial of an oral NK3R antagonist (MLE4901) in 28 women aged 40 to 62 years, experiencing >7 hot flashes/24 h; some bothersome or severe (Clinicaltrials.gov, NCT02668185)...NK3R antagonists do not increase serum estradiol or FSH despite their reduction in hot flashes. This is clinically significant and highly reassuring for women who have a contraindication to conventional hormone therapy such as prior/existing breast cancer and/or thromboembolism.
  • ||||||||||  Livoletide (AZP-531) / Millendo Therap, Jazz
    Enrollment closed:  ZEPHYR: Effects of Livoletide (AZP-531) on Food-related Behaviors in Patients With Prader-Willi Syndrome (clinicaltrials.gov) -  Apr 7, 2020   
    P2b,  N=158, Active, not recruiting, 
    This is clinically significant and highly reassuring for women who have a contraindication to conventional hormone therapy such as prior/existing breast cancer and/or thromboembolism. Recruiting --> Active, not recruiting
  • ||||||||||  nevanimibe (ATR-101) / Tempest Therap
    Trial completion date, Trial primary completion date:  Nevanimibe HCl for the Treatment of Classic CAH (clinicaltrials.gov) -  Mar 11, 2020   
    P2,  N=24, Recruiting, 
    Recruiting --> Active, not recruiting Trial completion date: Mar 2020 --> Dec 2020 | Trial primary completion date: Mar 2020 --> Dec 2020
  • ||||||||||  nevanimibe (ATR-101) / Tempest Therap
    Enrollment change:  A Study of ATR-101 for the Treatment of Congenital Adrenal Hyperplasia (clinicaltrials.gov) -  Feb 23, 2020   
    P2,  N=10, Completed, 
    Trial completion date: Mar 2020 --> Dec 2020 | Trial primary completion date: Mar 2020 --> Dec 2020 N=15 --> 10
  • ||||||||||  AZD4901 / AstraZeneca
    Kisspeptin and neurokinin B interactions in modulating gonadotropin secretion in women with PCOS  () -  Dec 16, 2019 - Abstract #Fertility2020FERTILITY_42;    
    Women with PCOS (based on the Rotterdam criteria) were either administered NK3Ra (MLE4901) 40mg bd for 7 days on day 1-2 of induced menstruation (n=8) or received no treatment, acting as controls (n=7)... These data demonstrate the interactive regulation of GnRH/LH secretion by NKB and kisspeptin in PCOS, and that the NKB system mediates aspects of estrogenic feedback.
  • ||||||||||  nevanimibe (ATR-101) / Tempest Therap
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date:  A Study of ATR-101 for the Treatment of Endogenous Cushing's Syndrome (clinicaltrials.gov) -  Sep 19, 2019   
    P2,  N=4, Terminated, 
    These data demonstrate the interactive regulation of GnRH/LH secretion by NKB and kisspeptin in PCOS, and that the NKB system mediates aspects of estrogenic feedback. N=16 --> 4 | Trial completion date: Nov 2020 --> Aug 2019 | Recruiting --> Terminated | Trial primary completion date: Nov 2020 --> Jun 2019; Slow enrollment
  • ||||||||||  nevanimibe (ATR-101) / Tempest Therap
    Trial completion date, Trial primary completion date:  A Study of ATR-101 for the Treatment of Endogenous Cushing's Syndrome (clinicaltrials.gov) -  Oct 25, 2018   
    P2,  N=16, Recruiting, 
    Not yet recruiting --> Recruiting Trial completion date: Nov 2018 --> Nov 2020 | Trial primary completion date: Nov 2018 --> Nov 2020
  • ||||||||||  pavinetant (AZD4901) / AstraZeneca, Tempest Therap, NN1213 / Novo Nordisk
    Trial completion, Enrollment change:  Neuropeptide Treatment for Hot Flushes During the Menopause (clinicaltrials.gov) -  Jun 26, 2018   
    P2,  N=67, Completed, 
    Trial completion date: Nov 2018 --> Nov 2020 | Trial primary completion date: Nov 2018 --> Nov 2020 Active, not recruiting --> Completed | N=30 --> 67
  • ||||||||||  nevanimibe (ATR-101) / Tempest Therap
    Trial completion, Trial primary completion date, Metastases:  Phase 1 Study of ATR-101 in Subjects With Advanced Adrenocortical Carcinoma (clinicaltrials.gov) -  Nov 6, 2017   
    P1,  N=63, Completed, 
    Active, not recruiting --> Completed Recruiting --> Completed | Trial primary completion date: Feb 2019 --> Nov 2016
  • ||||||||||  pavinetant (AZD4901) / AstraZeneca, Tempest Therap
    Enrollment change, Trial termination, Trial primary completion date:  MLE4901 vs. Placebo for the Treatment of PCOS (clinicaltrials.gov) -  Oct 2, 2017   
    P2,  N=55, Terminated, 
    Recruiting --> Completed | Trial primary completion date: Feb 2019 --> Nov 2016 N=130 --> 55 | Active, not recruiting --> Terminated | Trial primary completion date: May 2018 --> Sep 2017; The risk/benefit profile no longer indicated continued development.
  • ||||||||||  pavinetant (AZD4901) / AstraZeneca, Tempest Therap
    Enrollment closed:  MLE4901 vs. Placebo for the Treatment of PCOS (clinicaltrials.gov) -  Jun 22, 2017   
    P2,  N=130, Active, not recruiting, 
    N=130 --> 55 | Active, not recruiting --> Terminated | Trial primary completion date: May 2018 --> Sep 2017; The risk/benefit profile no longer indicated continued development. Recruiting --> Active, not recruiting
  • ||||||||||  pavinetant (AZD4901) / AstraZeneca, Tempest Therap
    Enrollment change:  MLE4901 vs. Placebo for the Treatment of PCOS (clinicaltrials.gov) -  Apr 5, 2017   
    P2,  N=130, Recruiting, 
    Recruiting --> Active, not recruiting N=220 --> 130
  • ||||||||||  pavinetant (AZD4901) / AstraZeneca, Tempest Therap
    Enrollment closed:  Neuropeptide Treatment for Hot Flushes During the Menopause (clinicaltrials.gov) -  Mar 28, 2017   
    P2,  N=30, Active, not recruiting, 
    N=220 --> 130 Recruiting --> Active, not recruiting