Mechanistic and Pharmacokinetic Studies of Classical Chinese Formula Xiao Chai Hu Tang (XCHT) Against Irinotecan-Induced Gut Toxicities(Clinical Study Part:Randomized Controlled Trial)

Randomized double-blind placebo-controlled trial (RCT) study, to determine the impact of XCHT on irinotecan-induced severe delayed-onset diarrhea (SDOD), and to determine the feasibility of using plasma raloxifene-4'-glucuronide as a probe for intestinal UGT activity.

Start Date08 Mar 2024

Sponsor / Collaborator

Guangzhou University of Chinese Medicine

[+1]

CTR20213368 / CompletedNot Applicable

盐酸雷洛昔芬片在健康成年受试者中单次空腹及高脂餐后口服给药的随机、开放、两周期、两序列、交叉设计生物等效性试验方案

[Translation] A randomized, open-label, two-period, two-sequence, crossover bioequivalence study of raloxifene hydrochloride tablets in healthy adult subjects after single oral administration on an empty stomach or after a high-fat meal

研究重庆圣华曦药业股份有限公司生产的盐酸雷洛昔芬片（规格：60mg）在中国健康受试者中空腹及高脂餐后以口服途径单次给药的药代动力学特征，并以Eli Lilly Nederland B.V持有Lilly,S.A.生产的盐酸雷洛昔芬片（商品名：EVISTA®；规格：60mg）为参比制剂，进行生物等效性评价。考察盐酸雷洛昔芬片受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

The pharmacokinetic characteristics of raloxifene hydrochloride tablets (specification: 60 mg) produced by Chongqing Shenghuaxi Pharmaceutical Co., Ltd. were studied after a single oral administration in Chinese healthy subjects on an empty stomach and after a high-fat meal. The bioequivalence evaluation was performed using raloxifene hydrochloride tablets (trade name: EVISTA®; specification: 60 mg) produced by Lilly, S.A. owned by Eli Lilly Nederland B.V. as the reference preparation. The safety of the test preparation and reference preparation of raloxifene hydrochloride tablets in healthy subjects was investigated.

Start Date21 Dec 2021

Sponsor / Collaborator

Chongqing Shenghuaxi Pharmaceutical Co. Ltd.

EUCTR2021-002476-39-IT / Not yet recruitingPhase 4

Prospective study to evaluate the effects of Raloxifene therapy on SARS-CoV-2 immunity after COVID-19 vaccination - RALOXIVAXI

Start Date29 Jul 2021

Sponsor / Collaborator-

100 Clinical Results associated with Raloxifene Hydrochloride

100 Translational Medicine associated with Raloxifene Hydrochloride

100 Patents (Medical) associated with Raloxifene Hydrochloride

3,685

Literatures (Medical) associated with Raloxifene Hydrochloride

01 Feb 2025·COLLOIDS AND SURFACES B-BIOINTERFACES

Effect of co-loaded vitamin D3 on intravenous injectable raloxifene delivery system

Article

Author: Yang, Shu-Jyuan ; Chang, Chih-Hao ; Young, Tai-Horng ; Yao, Wei-Cheng

Owing to its promising advantages, including improved drug bioavailability and therapeutic efficiency at low doses and frequency, increased patient convenience and compliance, and prolonged storage life, nanomedicine has received heightened attention over conventional pharmaceuticals. Human serum albumin (HSA)-based nanoparticles have been used as drug carriers in injectable formulations, with great success and versatility. In this study, raloxifene and vitamin D3 were co-encapsulated in HSA-based nanoparticles (Ral/VitaD/HSA/PSS NPs) as an intravenously injected pharmaceutical formulation in order to enhance their availability in the body. The lyophilization-hydration method was utilized to develop the Ral/VitaD/HSA/PSS NPs. In addition, the characteristics and stability of the NP and the effect of the co-loading of vitamin D3 on raloxifene release in vitro and in vivo were discussed. The raloxifene and vitamin D3 molecules were successfully encapsulated and well dispersed in an amorphous state within Ral/VitaD/HSA/PSS NPs. The prepared Ral/VitaD/HSA/PSS NPs were lyophilized for long-term storage and were both biocompatible and hemocompatible, enhancing alkaline phosphtase activity in osteoblasts. Delivered via intravenous injection, Ral/VitaD/HSA/PSS NPs addressed the low bioavailability of raloxifene and vitamin D3 caused by oral administration, and improved their compatibility and residence time in the body. Overall, the established raloxifene-vitamin D3-co-loaded NPs may be a potential nanomedicine contender for treating postmenopausal osteoporosis.

01 Jan 2025·INTERNATIONAL ENDODONTIC JOURNAL

27‐Hydroxycholesterol contributes to hypercholesterolemia‐associated aggravation of apical periodontitis in ovariectomized rats and raloxifene counteracts its action

Article

Author: Wang, H.‐W. ; Lin, S.‐K. ; Wu, F.‐Y. ; Cheng, S.‐J. ; Lai, E. H.‐H. ; Hong, C.‐Y. ; Lin, H.‐Y. ; Shun, C.‐T. ; Kok, S.‐H. ; Yang, C.‐N.

Abstract:

Aim:

The influence of hypercholesterolemia on the development of apical periodontitis (AP) is inconclusive. Recent studies revealed that cholesterol metabolite 27‐hydoxycholesterol (27HC) can affect cellular responses to bacterial infections and oestrogen status and raloxifene may influence its action. Herein, we aimed to examine the impact of 27HC on production of inflammatory mediators by macrophages and the regulatory function of raloxifene. The contribution of 27HC to AP development and the therapeutic effect of raloxifene were evaluated in a rat model.

Methods:

Murine macrophages J774 cells were used. The expression of inducible nitric oxide synthase (iNOS) was examined by Western blot. The concentrations of C‐C motif chemokine ligand (CCL) 2 and 27HC were assessed by enzyme‐linked immunosorbent assay. Colorimetric assay was used to evaluate cholesterol levels. Experimental AP was induced in ovariectomized (OVX) or un‐operated rats receiving high‐fat/high‐cholesterol diet (HFHCD) or normal diet (ND). Micro‐computed tomography and immunohistochemistry were employed to evaluate disease severity and the therapeutic effect of raloxifene.

Results:

Cholesterol enhanced 27HC production in macrophages. 27HC induced iNOS and CCL2 synthesis by macrophages and estradiol suppressed the responses. In our animal model of AP, HFHCD plus OVX significantly augmented serum and lesion tissue levels of 27HC (p < .05 versus the ND group). Lesion size, infiltration of CD68+ cells, and iNOS+ monocytes were increased in parallel with 27HC accumulation. Raloxifene inhibited pro‐inflammatory effects of 27HC on macrophages and suppressed AP progression in HFHCD/OVX rats (p < .05 versus the vehicle control group).

Conclusions:

Our results suggested that 27HC contributes to AP aggravation associated with hypercholesterolemia. Oestrogen deficiency may both enhance 27HC production and exacerbate its downstream action.

01 Dec 2024·PROSTAGLANDINS & OTHER LIPID MEDIATORS

The effect of raloxifene supplementation on blood pressure and Apo-lipoproteins in postmenopausal women: A systematic review and meta-analysis

Review

Author: Noshadi, Nooshin ; Alipour, Beitullah ; Kazemi, Fatemeh ; Akhavan Tabib, Farzaneh ; Aghili, Sarehnaz ; Tabib, Farzaneh Akhavan ; Bonyadian, Atefeh ; Abbasalizad-Farhangi, Mahdieh ; Zarian, Salehe ; Darzi, Melika

INTRODUCTION:

Several studies indicated the ameliorating effects of raloxifene supplementation on apolipoproteins and blood pressure, although others have conflicting findings. Therefore, the present study was conducted in order to accurately and definitively understands the effect of raloxifene on apolipoprotein AI (Apo-AI), apolipoprotein B (APoB), lipoprotein (a) (Lp (a)), systolic blood pressure (SBP) and diastolic blood pressure (DBP) in postmenopausal women.

METHODS:

A systematic literature search was conducted using scientific databases including PubMed, Scopus, Embase, and Web of Science and the Cochrane Library, through May 2024. The quality of studies was assessed using Cochrane tool. Random-effects meta-analysis was used to pool standardized mean differences (SMD) and 95 % CI for the outcomes.

RESULTS:

Twenty trials, with interventions ranging from 6 to 144 weeks and 2825 participants, were included. Raloxifene supplementation demonstrated significant reductions in ApoB (SMD: -0.92; 95 % CI: -1.49 to -0.35; P = 0.001), and Lp (a) (SMD: -0.25; 95 % CI: -0.39 to -0.11; P < 0.001) while increasing Apo-AI levels (SMD: 0.29; 95 % CI: 0.22-0.36; P < 0.001). Conversely, no significant effects were observed on SBP (WMD: -0.49 mmHg; 95 % CI: -3.01-2.04; P = 0.706), and DBP (WMD: -0.81 mmHg; 95 % CI: -4.04-2.41; P = 0.621). Moreover, subgroup analysis indicated that raloxifene significantly decreased DBP in studies with intervention durations of >12 weeks.

CONCLUSIONS:

This meta-analysis has shown that raloxifene supplementation may have beneficial effects on apolipoproteins in postmenopausal women. Future studies are needed to investigate the effect of raloxifene on health status in in postmenopausal women.

News (Medical) associated with Raloxifene Hydrochloride

10 Sep 2024

·www.drugs.com

Review Weighs Treatments for Genitourinary Symptoms of Menopause

TUESDAY, Sept. 10, 2024 -- Vaginal estrogen, vaginal dehydroepiandrosterone (DHEA), oral ospemifene, and vaginal moisturizers may be beneficial for some genitourinary symptoms of menopause (GSM), according to a review published online Sept. 10 in the Annals of Internal Medicine . Elisheva R. Danan, M.D., M.P.H., from the University of Minnesota in Minneapolis, and colleagues examined the effectiveness and harms of vaginal estrogen, nonestrogen hormone therapies, and vaginal moisturizers for treatment of GSM in a systematic review of randomized controlled trials (RCTs). A total of 46 RCTs assessing vaginal estrogen, nonestrogen hormones, vaginal moisturizers, or multiple interventions were identified from 11,993 citations. The researchers found that vaginal estrogen may improve vulvovaginal dryness, dyspareunia , the most bothersome symptom, and treatment satisfaction compared with placebo or no treatment. Vaginal DHEA may improve dryness, dyspareunia, and distress, bother, or interference from genitourinary symptoms compared with placebo; oral ospemifene may improve dryness, dyspareunia, and treatment satisfaction; and dryness may also be improved by vaginal moisturizers (all low certainty of evidence [COE]). No benefit or uncertain effects (low and very low COE, respectively) may be provided by vaginal testosterone, systemic DHEA, vaginal oxytocin, and oral raloxifene or bazedoxifene. Reporting was limited by studies of short duration that were insufficiently powered to assess infrequent serious harms. "Future studies would be strengthened by standard definitions of symptoms and uniform diagnostic criteria for GSM, a common set of validated outcome measures and reporting standards, and attention to clinically relevant patient populations and intervention comparisons," the authors write.

Clinical Result

24 May 2023

·www.biospace.com

New Data Reveal Role of SARS-Cov-2 Spike Protein in Covid-19 Associated Coagulopathy

Unprecedented comprehension of the interaction between Spike and the Human Estrogen Receptor Alfa provides insights for a new generation of anti SARS-CoV-2 and pan-Coronavirus vaccines Italian and US researchers have revealed how the SARS-CoV-2 Spike protein interacts with human Estrogen Receptor-α (ERα) leading to severe coagulopathy observed in COVID-19 patients. The new data - published in Nature’s Signal Transduction and Targeted Therapy - shows that point mutations in the sequence of SARS-CoV-2 Spike (S)-protein eliminate its pro-coagulation effect without compromising immunogenicity. The findings provide actionable insights for designing vaccines lacking of estrogen-receptor mediated side effects for all coronavirus strains and other viral infections. MILAN & SAN MATEO, Calif.--(BUSINESS WIRE)-- Dompé farmaceutici announced today new peer-reviewed data demonstrating that small changes in the SARS-CoV-2 Spike (S)-protein sequence can eliminate its effect in inducing coagulation1. The tendency for the Spike protein to stimulate inflammatory and coagulation has been implicated in coagulopathy observed in the lungs, heart and kidneys of COVID-19 patients with a similar and extremely rare effects observed in a minority of patients who received COVID-19 vaccines. This press release features multimedia. View the full release here: Framework Dompé farmaceutici Biotech production (Photo: Business Wire) Data stemmed from the EXSCALATE supercomputing calculation predicted a potential function of Spike (S) as a co-factor for human ERα nuclear signalling. This interaction is mediated by a nuclear receptor co-regulator (NRC) LXD-like motif present on the viral protein S2 subunit, and the activation function 2 (AF-2) region on ERα2. This work builds on other recent studies3,4 showing that coagulopathy is clearly associated with the interaction of the SARS-CoV-2 Spike (S) protein with the human Erα. While circulating estrogens play a protective role by regulating the immune response to infection, modulation of ERα signalling in SARS-CoV-2-infected lung tissue stimulates proinflammatory signals leading to hypertrophy, vasoconstriction, and vessel obstruction. In the new article the scientists of the italo-american collaboration (encompassing Centro Cardiologico Monzino in Italy and the National Institute on Drug Abuse and the Johns Hopkins School of Medicine in the US) demonstrated that the interaction between the Spike protein and ERα leads to an increase in tissue factor (TF) and the overall pro-coagulation activity in two human endothelial cell lines. The results were further validated by overexpressing S-protein in mice. This pro-coagulative function of Spike in vitro and in vivo, was abolished or strongly reduced by the variants of the Spike proteins carrying mutations in the interaction domain with ERα (as predicted by EXSCALATE). “The value and benefits of vaccines in countering the COVID-19 pandemic remain unquestionable and overwhelming compared to the risks associated with infection from SARS-CoV-2” underscores Maurizio Pesce, a research Group Leader at the Monzino Cardiology Center in Milan, Italy, and initiator of the study in 2021 together with the leading Silvia Barbieri, another research Group Leader at Monzino, “We hope that our findings will be considered in the development of the next generation of vaccines reducing the residual side effects and risks. Our data also unravel a new function of the viral protein in direct regulation of thrombosis associated factors. This has general implications not only for COVID-19, but for other viral infections altering the coagulation pro patients”. “This continuing research is critical to understand the pathogenetic mechanisms associated with SARS-CoV2 infection and causal mechanisms of some rare COVID-19 vaccine side effects,” says Dompé farmaceutici Chief Scientific Officer Marcello Allegretti “Ongoing expanding data is revealing a well-conserved region with the same characteristics of the LXD-like motif present on the viral protein S2 subunit, also in other Coronaviruses. This evidence could open new scenarios in ‘pan-Coronavirus’ vaccination. We are excited to identify a path toward further refinement strategies to enable even more powerful benefits through future vaccination and booster initiatives”. ____________________________________________________________________________________ About Dompé Dompé is a private, rapidly scaling international biopharmaceutical company founded in Milan, Italy, with a 130-year legacy of medical innovation. The R&D department of the company is anchored by EXSCALATE, a structure-based virtual screening platform developed in-house that leverages one of the most powerful supercomputing and artificial intelligence platforms in the world. Today, Dompé employs more than 800 employees worldwide and maintains a US commercial operations hub in the San Francisco Bay Area as well as an R&D presence in Boston. Forward Looking Statements This press release refers to certain information that may not coincide with expected future results. Dompé firmly believes in the soundness and reasonableness of the concepts expressed. However, some of the information is subject to a certain degree of indetermination in relation to its research and development activities and the necessary verifications to be performed by regulatory bodies. Therefore, as of today, Dompé cannot guarantee that the expected results will be consistent with the information provided above. 1. SS Barbieri et al. Relevance of the viral Spike protein/cellular Estrogen Receptor-α interaction for endothelial-based coagulopathy induced by SARS-CoV-2 - Signal Transduction and Targeted Therapy - 2. Allegretti, M. et al. Repurposing the estrogen receptor modulator raloxifene to treat SARS-CoV-2 370 infection. Cell Death Differ. 29, 156-166 (2022). 371 - 3. Wilcox et al. Sex Differences in Thrombosis and Mortality in Patients Hospitalized for COVID-19, Am J Cardiol. 2022 May 1; 170: 112–117 - 4. Science Advances - The SARS-CoV-2 spike protein binds and modulates estrogen receptors - eadd4150 (2022) 30 November 2022 -

Vaccine

30 Nov 2022

·www.prnewswire.com

Dompé: New Published Data Point to Spike Protein Interactions with Estrogen Receptors as a cause for Coagulopathy in COVID-19 Patients, Signaling Sex Effects and a Path to Improved Vaccines

- A team of US and European researchers have released new findings in Science Advances showing how the SARS-CoV-2 Spike (S)-protein interacts with human Estrogen Receptor Alpha (ERα) in lung tissue - Data released as pre-print on bioRxiv reveals the interaction of SARS-CoV-2 (S) Spike proteins with ERα may increase the pro-coagulation activity of endothelial cells, enhancing the risk of thrombosis and shedding new light on the pathogenic mechanisms underlying SARS-CoV-2 infection and on its sex-specific differences - Additional data by the same research groups highlights the mechanism underlying some rare vaccine-associated coagulopathies, which may be prevented by small changes in the Spike sequence used to produce currently available vaccines MILAN and SAN MATEO, Calif., Nov. 30, 2022 /PRNewswire/ -- Dompé farmaceutici announced new data revealing a novel function of the SARS-CoV-2 Spike (S) protein interaction with the human Estrogen Receptor Alpha (ERα) that may lead to the severe coagulopathy observed in patients with COVID-19 and a minority of subjects receiving the SARS-CoV-2 vaccine. The data published today in Science Advances[1] is a collaboration between researchers from Dompé farmaceutici, the National Institute on Drug Abuse, part of the U.S. National Institutes of Health, Johns Hopkins University, The Scripps Institute, Stanford School of Medicine, and the University of L'Aquila, in Italy. Continue Reading A virtual working environment: Exscalate platform is capable of evaluating more than three million molecules per second drawing on a “chemical library” of trillion molecules. Related Documents View PDF Science Advances It is well understood that the SARS-CoV-2 virus can cause severe vasculopathy, which may, in turn, result in fatal thrombosis. The team's findings are consistent with the sex-specific differences in thrombosis observed in hospitalized patients with COVID-19, and in a minority of subjects receiving the SARS-CoV-2 vaccine, as reported earlier this year in the American Journal of Cardiology[2] by an unrelated team. The initial finding leading to the study emerged from the results of the Exscalate4CoV[3] (E4C) project, a group composed of 30 public and private institutions from seven countries and funded by EU Commission's in the frame of its Horizon 2020 Framework Programme[4], aimed at fighting Coronavirus with the latest European supercomputing resources and experimental facilities. The project leveraged the computational power of Exscalate, Dompé's supercomputing platform exploiting a database of 500 billion molecules to find those capable of targeting clinically relevant coronavirus variants. Due to its processing capacity of more than 3 million molecules per second, Exscalate is currently the most powerful intelligent supercomputing drug design platform running on Leonardo[5], the 4th most powerful supercomputer in the world. This processing power allowed the E4C researchers to rapidly select and repurpose a generic molecule (raloxifene) with known efficacy and tolerability as an estrogen modulator for treating osteoporosis. Using the Exscalate platform to identify Spike protein binding partners beyond the canonical ACE2 receptor, researchers identified prominent interactions between two human estrogen receptors (ERα, ERβ) and SARS-CoV-2 Spike protein. After an unbiased primary screen to profile the binding of full-length Spike protein against more than 9,000 human proteins, researchers found a consistent interaction with the human estrogen receptor alpha (ERα). Similarly, high ERα levels were measured in the damaged lungs of infected hamsters, as well as in human postmortem lung samples. The researchers suggest that, given the role of ERα in the coagulation cascade, S-protein could increase the pro-coagulation activity of endothelial cells leading to an enhanced risk of thrombosis. While circulating estrogens play a protective role by regulating the immune response to infection, it may be possible that the modulation of ER signaling in SARS-CoV-2-infected lung tissue can stimulate proinflammatory signals leading to hypertrophy, vasoconstriction, and vessel obstruction. This concept has been validated by a further set of experimental findings, which are currently released in a pre-print[6] and submitted to a peer-reviewed publication, demonstrating that the interaction between the Spike protein and ERα leads to an increase in tissue factor (TF) and overall pro-coagulation activity in a human endothelial cell line, a result further confirmed by overexpressing S-protein in mice. These findings are consistent with the researchers' demonstration that deletion of the appropriate point mutations in the Spike sequence abolished the binding of ERα and its effects without compromising its immunogenicity and pointing at a way to mitigate the rare side effects observed with the currently available vaccines. "Supercomputing has already demonstrated its capacity to find answers to questions we could not answer only a few years ago," underscored Roberto Viola, Director-General of the European Commission's Directorate-General for Communications Networks, Content and Technology (DG CONNECT) who last week inaugurated Leonardo supercomputer in Bologna, Italy. "And it will increasingly help us find solutions in all kinds of areas: from climate change with extreme weather forecasts and urban planning to understanding human brain and body. Medicine is the field where supercomputing is already giving concrete fruits. I am very proud of the support which the European Commission gave to the Exscalate4Cov consortium to discover promising leads for fighting COVID-19 more effectively." "Eventually, the overall evidence provides a solid rationale for some previously published results[7] obtained by our team," said Dompé farmaceutici's Chief Scientific Officer, Marcello Allegretti, "namely the beneficial role of Estrogen Receptor modulators, especially raloxifene, in preventing some of the infection side-effects and support raloxifene use for both therapy and vaccine side-effects mitigation." About Dompé Dompé is a private, rapidly scaling international biopharmaceutical company founded in Milan, Italy, with a 130-year legacy of medical innovation. The R&D department of the company is anchored by EXSCALATE, a structure-based virtual screening platform developed in-house that leverages one of the most powerful supercomputing and artificial intelligence platforms in the world. Today, Dompé employs more than 800 employees worldwide and maintains a US commercial operations hub in the San Francisco Bay Area as well as an R&D presence in Boston. Forward Looking Statements This press release refers to certain information that may not coincide with expected future results. Dompé firmly believes in the soundness and reasonableness of the concepts expressed. However, some of the information is subject to a certain degree of indetermination in relation to its research and development activities and the necessary verifications to be performed by regulatory bodies. Therefore, as of today, Dompé cannot guarantee that the expected results will be consistent with the information provided above. 1. Science Advances - The SARS-CoV-2 spike protein binds and modulates estrogen receptors - eadd4150 (2022) 30 November 2022 - . 2. Wilcox et al. Sex Differences in Thrombosis and Mortality in Patients Hospitalized for COVID-19, Am J Cardiol. 2022 May 1; 170: 112–117, . 3. The Exscalate4Cov () consortium, supported by the the EU's Horizon 2020 programme for research and innovation, was coordinated by Dompé farmaceutici, and composed by 18 member institutions from seven European countries: Politecnico di Milano (Dept. of Electronics, Information and Bioengineering), Consorzio Interuniversitario CINECA(Supercomputing Innovation and Applications), Università degli Studi di Milano (Department of Pharmaceutical Sciences), International Institute of Molecular and Cell Biology in Warsaw (Warsaw, Poland), KU Leuven, Elettra Sincrotrone Trieste, Fraunhofer Institute for Molecular Biology and Applied Ecology, BSC Barcelona Supercomputing Centre, Forschungszentrum Jülich, Università Federico II di Napoli, Università degli Studi di Cagliari, SIB Swiss Institute of Bioinformatics, KTH Royal Institute of Technology (Department of Applied Physics), Associazione Big Data, Istituto Nazionale di Fisica Nucleare (INFN), Istituto nazionale per le malattie infettive Lazzaro Spallanzani and Chelonia Applied Science. Part of E4C League were: ENI, SAS, Alfasigma, CFEL Center for Free-Electron Laser Science, MMV Medicines for Malaria Ventures, Esteve Pharmaceutical, University of Basel Biozentrum, University of Basel Innovation Office, University of Basel Department of Pharmaceutical Sciences, D-wave, Pierre fabre, Greenpharma, University of Sheffield - Sheffield Institute for Translational Neuroscience – SITraN, Dassault Systemes- Biovia, Institute of Food Science Research, CECAM Centre Européen de Calcul Atomique et Moleculaire, Nanome, Esteco, IT4Innovation, Università degli Studi della Tuscia, Sofia University "St. Kl. Ohridski," Faculty of Physics, Institut Cochin. 4. EXaSCale smArt pLatform Against paThogEns for Corona Virus / Grant agreement ID: 101003551 . 5. . 6. Silvia Barbieri et al. - Relevance of the viral Spike protein/cellular Estrogen Receptor-a interaction for endothelial-based coagulopathy induced by SARS-CoV-2; BioRxiv . 7. Allegretti, M. et al. Repurposing the estrogen receptor modulator raloxifene to treat SARS-CoV-2 370 infection. Cell Death Differ. 29, 156-166 (2022). 371. Photo - PDF - Logo - SOURCE Dompé farmaceutici S.p.A

Vaccine

100 Deals associated with Raloxifene Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D02217	Raloxifene Hydrochloride	G03XC01	DB00481

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Breast Cancer	US	Eli Lilly & Co.	13 Sep 2007
Osteoporosis, Postmenopausal	US	Eli Lilly & Co.	09 Dec 1997

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 3	FR	Dompe Farmaceutici SpA	22 Jan 2021
COVID-19	Phase 3	IT	Dompe Farmaceutici SpA	22 Jan 2021
COVID-19	Phase 3	ES	Dompe Farmaceutici SpA	22 Jan 2021
Cardiovascular Diseases	Phase 3	US	Eli Lilly & Co.	01 Jun 1998
Invasive Mammary Carcinoma	Phase 3	US	Eli Lilly & Co.	01 Jun 1998
Hemorrhagic Fever, Ebola	Phase 2	IT	Dompe Farmaceutici SpA	30 Jan 2022
Hepatitis B	Phase 2	IT	Dompe Farmaceutici SpA	30 Jan 2022
Hepatitis C, Chronic	Phase 2	IT	Dompe Farmaceutici SpA	30 Jan 2022
Zika Virus Infection	Phase 2	IT	Dompe Farmaceutici SpA	30 Jan 2022
Hot Flashes	Phase 2	US	Eli Lilly & Co.	01 Feb 2002

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


DDW2022	Not Applicable	Osteoporosis, Postmenopausal	-	Raloxifene	fnglghzuqw(yetrpkenpc): OR = 1.854 (95% CI, 1.643 - 2.092) View more	-	24 May 2022
				No Raloxifene
DDW2022	Not Applicable	Osteoporosis, Postmenopausal	-	Raloxifene	sezzpodalo(beeecsgarn): OR = 1.854 (95% CI, 1.643 - 2.092) View more	-	24 May 2022
				No Raloxifene
DDW2022	Not Applicable	Osteoporosis, Postmenopausal	-	Raloxifene	wsvetjthjg(ojdakhmmrx): OR = 1.854 (95% CI, 1.643 - 2.092) View more	-	24 May 2022
				No Raloxifene
DDW2022	Not Applicable	Osteoporosis, Postmenopausal	-	Raloxifene	ofsyzlvuai(awfgwfebiv): OR = 1.854 (95% CI, 1.643 - 2.092) View more	Negative	24 May 2022
				No Raloxifene
DDW2022	Not Applicable	Osteoporosis, Postmenopausal	-	Raloxifene	sfycwisxgb(ruruavyotf): OR = 1.854 (95% CI, 1.643 - 2.092) View more	Negative	24 May 2022
				No Raloxifene
P0903 (ERA2020)	Not Applicable	Chronic Kidney Diseases	39,128	Osteoporosis medications (bisphosphonates, raloxifene, teriparatide, or denosumab)	hroeyifjxy(tedvdhpgpw) = nabhyxnxfo sgeostukmr (odlyhfligd ) View more	Negative	06 Jun 2020
2020 ARVO Annual Meeting (ARVO2020)	Phase 2	Brain Injuries, Traumatic	-	Raloxifene 5 mg/kg	vlsmhzvsub(olypdqkrum) = reduced or eliminated dnbjzxlkep (tfnswbnrrj ) View more	Positive	01 Jun 2020
				Raloxifene 10 mg/kg
NCT00687102 (Co-STAR, CTgov)	Phase 3	Cognition	1,498	Tamoxifen (Star Participants Assigned to Tamoxifen)	exohvwkxcb(phldedcspc) = kcnaqzcyot wiadksqbzn (slndzgogvp, qkzbiunlhs - bjbjdiphkj) View more	-	23 Jan 2018
				raloxifene (Star Participants Assigned to Raloxifene)	exohvwkxcb(phldedcspc) = vcsjdsjdfd wiadksqbzn (slndzgogvp, rmxkprmoxu - faazrhhzej) View more
NCT01280305 (Pubmed \| J Clin Psychiatry)	Phase 3	Schizoaffective disorder \| Schizophrenia	200	Raloxifene 120 mg/d plus antipsychotics	znaskjqiyb(vfghmijnlf): P-Value = < .001	Negative	01 Jul 2017
				Placebo plus antipsychotics

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