Portal hypertension (an increase in blood pressure in the portal vein that carries the blood from the intestine and spleen to the liver) underlies most of the serious complications of liver cirrhosis. This randomised placebo controlled study in people with liver cirrhosis evaluates the acute effects serelaxin (RLX030) infusion on portal hypertension and liver blood flow.

Start Date18 Oct 2017

Sponsor / Collaborator

The University of Edinburgh

[+2]

NCT02625922

/ TerminatedPhase 2

A Multicenter, Randomized, Double-blind, Crossover Placebo-controlled Phase II Study to Assess the Effect of Serelaxin Versus Placebo on High-sensitivity Cardiac Troponin I (Hs-cTnI) Release in Patients With Chronic Heart Failure After Exercise When Used in Addition to Standard of Care

This was a multicenter, randomized, double-blind, crossover, placebo-controlled, Phase II clinical study that evaluated the effect of serelaxin versus placebo (both in addition to SoC) on the release of hs-cTnI, in patients with CHF after an exercise testing session.

Start Date05 Feb 2016

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

PER-023-15

/ CompletedPhase 3

A MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO- CONTROLLED PHASE IIIB STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SERELAXIN WHEN ADDED TO STANDARD THERAPY IN ACUTE HEART FAILURE PATIENTS

Start Date22 Oct 2015

Sponsor / Collaborator-

100 Clinical Results associated with Serelaxin

100 Translational Medicine associated with Serelaxin

100 Patents (Medical) associated with Serelaxin

287

Literatures (Medical) associated with Serelaxin

01 Apr 2026·Pakistan Journal of Pharmaceutical Sciences

Serelaxin Alleviates Ischemia Reperfusion-Induced Kidney Injury By Modulating Inflammatory Response And Inhibiting Of Notch-2/Hes-1 Signaling Pathway

Article

Author: R Tweij, Thu-Alfeqar ; Jasim Al-Zurfi, Atheer Mohammed ; Mohammed Rabeea, Shahad Ali ; A Alyasiry, Esraa

Background: Renal transplantation is the last standard option for the treatment of patients with end-stage renal failure. During renal transplantation, the renal damage occurs after a short time of warm ischemia after the harvest of the kidney from the donor, a long period of the cold ischemia through cryopreservation and a last phase of the warm ischemia through recipient implantation. Ischemia reperfusion (IR) complications are one of the challenges of transplantation. Objectives: The study aimed to diagnose the protective effect of serelaxin against kidney damage induced by IR and to understand the possible impact of the Notch-2/Hes-1 signaling pathway in this problem. Methods: Eighteen Sprague Dawley rats were divided into three groups: serelaxin group was treated with serelaxin (5?g/kg SC), while the control group was treated with distilled water and the sham group was not treated with serelaxin or D.W. The renoprotective effect of serelaxin was studied by assessing the kidney function by measuring of serum urea and creatinine. The anti-inflammatory impact, was evaluated by measurement of interleukin-1?. Also the effect of serelaxin on Notch-2/Hes-1 pathway in ischemia reperfusion injury was investigated. Results: The results disclosed that serelaxin pretreatment remarkably restored S.u, S.cr, and ameliorated kidney damage. Through IHC, the result showed that serelaxin produced a magic effect against IRI through downregulated the protein expression of cytoplasmic and nuclear cleaved Notch-2 in addition to nuclear Hes-1. Serelaxin also produced potent anti-inflammatory effect via the reduction in the protein expression of the IL-1?. Conclusion: These results highlight the nephroprotective effects of serelaxin against IRI by numerous pathways that also include Notch-2/Hes1. These novel findings uphold the use of serelaxin or serelaxin derived agents as a promising medication for those illnesses in which IRI is the main pathogen.

01 Dec 2025·EUROPEAN JOURNAL OF HEART FAILURE

Clinical Profiles and Prognostic Impact of Residual Intravascular and Tissue Congestion in Acute Heart Failure

Article

Author: Davison, Beth A. ; Felker, G. Michael ; O'Conner, Christopher M. ; Cleland, John G.F. ; Greenberg, Barry ; Voors, Adriaan A. ; Givertz, Michael M. ; Voordes, Geert H.D. ; Pang, Peter S. ; Gimpelewicz, Claudio ; Filippatos, Gerasimos ; Metra, Marco ; Teerlink, John R. ; ter Maaten, Jozine M. ; Ceelen, Daan C.H. ; Cotter, Gad

Abstract:

Aims:

Residual congestion (RC) is common at discharge after acute decompensated heart failure (ADHF) and is associated with early mortality and rehospitalization. The prognostic value of distinct RC phenotypes (i.e. intravascular and tissue congestion) remains unclear. This analysis investigated RC phenotypes and their outcomes.

Methods and results:

Patients with congestion at admission from two large ADHF trials, PROTECT (rolofylline; index) and RELAX-AHF-2 (serelaxin; replication), were classified based on clinical signs at day 7/discharge as intravascular (jugular venous pressure) or tissue (pulmonary rales/peripheral oedema) congestion, each alone, combined or neither. Cox regression assessed 180-day mortality after adjusting for risk factors. Overall, 1557 patients with predominantly combined (i.e. tissue and intravascular) congestion at admission were included, with a median age of 72 years. By day 7 or discharge, 580 (37%) patients had RC. In these patients, intravascular congestion (n = 260; 45%) was most common, followed by combined (n = 185; 32%) and tissue (n = 135; 23%) congestion. During hospitalization, patients with solely intravascular RC had greater diuretic responses, shorter hospital stays and received lower doses of intravenous loop diuretics than those with tissue or combined congestion (all p < 0.05). Residual intravascular and tissue congestion were independently associated with increased 180-day mortality (hazard ratio [HR] 1.69, 95% confidence interval [CI] 1.15–2.49, and HR 2.07, 95% CI 1.25–3.41, respectively) compared to decongested patients. In the RELAX-AHF-2 substudy (n = 476), similar findings were observed.

Conclusions:

Patients with intravascular RC had better diuretic responses and shorter hospital stays than those with tissue/combined RC, but worse outcomes than decongested patients. This study highlights the importance of RC assessment to identify at-risk patients. Future studies should evaluate phenotype-guided treatments.

01 Oct 2025·JACC-Heart Failure

Clinical Presentation, Biomarker Trajectories, and Outcomes in Women and Men Hospitalized for Acute Heart Failure

Article

Author: Voors, Adriaan A ; Felker, G Michael ; Teerkink, John R ; Metra, Marco ; Qin, Hailun ; Gimpelewicz, Claudio ; Ravera, Alice ; Adamo, Marianna ; Santema, Bernadet T ; Ter Maaten, Jozine M ; Cotter, Gad ; Filippatos, Gerasimos S ; Ponikowski, Piotr ; Pang, Peter S ; Greenberg, Barry H ; Davison, Beth A ; Severin, Thomas

BACKGROUND:

Previous studies have shown important but sometimes heterogeneous differences between women and men with heart failure (HF).

OBJECTIVES:

This study aims to investigate sex differences in the phenotype and journey of men and women in a large contemporary acute heart failure (AHF) cohort.

METHODS:

The authors analyzed 6,545 AHF patients (40% women) enrolled in RELAX-AHF-2 (Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF).

RESULTS:

Women were older (78 vs 72 years; P < 0.001) and had higher ejection fraction (45% vs 35%; P < 0.001). During hospitalization, women received lower diuretic doses (furosemide equivalent through day 5: 200 vs 240 mg intravenous; P < 0.001) and achieved lower weight loss (relative; P = 0.026), with slightly lower diuretic response (-0.33 vs -0.36 kg/40 mg furosemide at day 5; P = 0.011) and similar sign and symptom improvement by day 5 compared with men (all adjusted P > 0.05). More women experienced worsening renal function by day 5 (WRF; adjusted HR: 1.24 [95% CI: 1.06-1.46]; P = 0.009). Women experiencing WRF had increased risk of 180-day cardiovascular death and rehospitalizations for HF or renal failure (RF) and of rehospitalizations for HF/RF compared with men and women without WRF (adjusted P for interaction: P < 0.001). Incidence of other outcomes was similar in women and men (all P > 0.20).

CONCLUSIONS:

During an AHF hospitalization, women received lower doses of loop diuretic agents and achieved less weight loss with slightly lower diuretic response compared with men, despite similar symptom relief and postdischarge outcomes. Early incident WRF was more frequent in women and was associated with worse 180-day outcomes. (Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF [RELAX-AHF-2]; NCT01870778).

News (Medical) associated with Serelaxin

10 Feb 2026

·www.fiercebiotech.com

AstraZeneca relaxed about relaxin drug\'s poor efficacy in phase 2 heart failure trial

AstraZeneca shared news it cut AZD3427 from its pipeline alongside the removal of two other new molecular entities.\n AstraZeneca executives have told Fierce Biotech they still see potential in harnessing the relaxin hormone to treat heart failure despite abandoning work on one of two clinical-stage candidates. As part of its full-year 2025 financial results (PDF), the U.K.-based Big Pharma revealed that it removed a long-acting relaxin-2 analog called AZD3427 from its pipeline, citing underwhelming efficacy in a phase 2 trial.There is a history of studying relaxin in cardiovascular settings—Novartis started a phase 3 heart failure trial of a recombinant relaxin-2 peptide in 2013—but preclinical evidence of the molecule’s vasodilatory, anti‐inflammatory and antifibrotic effects has yet to translate into clinical success.AstraZeneca identified the short half-lives of earlier candidates as a potential cause of the failures. To fix the problem, the company created a relaxin-2 mimic fusion protein and attached a fragment to create a candidate with a half-life measured in days rather than hours. However, AstraZeneca has now stopped development of AZD3427 after completing a phase 2 trial in 260 people with heart failure. While AZD3427 has been sunk by efficacy, the company is continuing to develop the oral relaxin drug candidate AZD5462. AstraZeneca has called (PDF) the candidate the first small molecule targeting relaxin biology to enter clinical trials. Data from a phase 2b trial of stable patients with chronic heart failure are due in the second half of 2026.During a press conference this morning, Sharon Barr, Ph.D., executive vice president of biopharmaceuticals R&D at AstraZeneca, told Fierce the company is moving forward with AZD5462 “because we think this is a potentially important molecule.”“One of the things that we have learned from competitor studies is that dosing matters,” Barr continued. “You really have to find that perfect space between efficacy and congestion, and we think we\'ve put in the hard yards to really understand the posology there, and we\'re moving forward with our existing program.”AstraZeneca CEO Pascal Soriot also told Fierce during the call that work on the relaxin program is a case study of “what is so exciting in this industry at this present time.”Soriot pointed to the likes of ACE inhibitors and SGLT2 drugs as examples of the progress made in recent years to treat specific groups of cardiovascular patients.“There\'s more and more of those technologies, and we need just to pick the right products to really help patients with heart disease,” the CEO added. AstraZeneca disclosed its discontinuation of AZD3427 alongside the removal of two other new molecular entities from the pipeline. The drugmaker confirmed the removal of AZD0233, a CX3CR1 modulator that was in development as a treatment for dilated cardiomyopathy. AstraZeneca terminated a phase 1 trial of the candidate last month over an adverse finding in a nonclinical, chronic toxicology study.The company also revealed it had axed a COVID-19 vaccine program. AstraZeneca moved the mRNA viruslike particle vaccine program into phase 1 in late 2023. Recently, the company reported that a vaccine candidate was well tolerated compared to Pfizer and BioNTech’s Comirnaty and generated similar immunogenicity at one-third of the dosage.

$AstraZeneca relaxed about relaxin drug\'s poor efficacy in phase 2 heart failure trial$

VaccinePhase 2Phase 1Financial Statement

19 Nov 2025

·thryvtrx.com

Amy Rudolph, PhD, Joins Thryv Therapeutics’ Board of Directors to Support Portfolio Progression into Heart Failure

Montreal, Quebec – November 19, 2025 – Thryv Therapeutics Inc., a clinical-stage biotechnology company advancing a series of novel serum glucocorticoid inducible kinase 1 (SGK1) inhibitors for inherited cardiac arrhythmias, cardiometabolic diseases, and cardiomyopathies, today announced that new preclinical data will be presented at the American Heart Association’s Scientific Sessions 2025, taking place November 8–10 in New Orleans, Louisiana. The American Heart Association’s Scientific Sessions bring together global experts to exchange the latest advancements in cardiovascular science, clinical care, and research. Thryv Therapeutics is honored to contribute to this important dialogue with its recent research highlighting the potential of SGK1 inhibition as a novel therapeutic strategy for cardiovascular disease, including heart failure. Dr. Rudolph currently serves as Head of Global Medical Affairs and Cross-TA Medical Affairs at Boehringer Ingelheim, where she leads a global transformation to build a market-leading Medical Affairs organization focused on external engagement, digital/AI integration, evidence generation, advanced analytics, and learning. “We are thrilled to welcome Amy Rudolph to our Board of Directors,” said Paul Truex, Chairman and CEO of Thryv Therapeutics. “Her extensive experience in medical affairs, evidence generation, and cross-functional drug development will be invaluable as we progress our SGK1 inhibitor pipeline toward late-stage clinical studies.” “We are also deeply grateful to Scott Weiner for his many contributions to the Board of Directors,” added Truex. “We’re pleased that he will remain closely involved with Thryv in an advisory capacity.” Prior to joining Boehringer Ingelheim, Dr. Rudolph held leadership roles at Novartis Pharmaceutical Corporation, where she served as Head of HCS (Healthcare Systems) Partnerships in Global Drug Development and Head of Evidence and Launch Excellence in Global Medical Affairs. Earlier in her career, she held key positions at Pfizer Inc., where she was responsible for the atherosclerosis and stroke platforms, early development, and licensing/technology evaluations, and began her scientific career with G.D. Searle/Pharmacia/Pfizer. Over the course of her career, Dr. Rudolph has played key roles in the development and launch of multiple cardiovascular therapies, including Inspra, Eliquis, Lipitor, Diovan, Diovan/HCT, Exforge, Tekturna, and Entresto, as well as in the development of Serelaxin and Amturnide. Dr. Rudolph earned her Ph.D. in Biochemistry and Molecular Biology from Washington University in St. Louis and is an inventor on 13 patents and numerous scientific publications spanning preclinical research, drug development, and real-world evidence. “I am honored to join Thryv Therapeutics’ Board of Directors,” said Amy Rudolph. “Thryv’s science and patient-centered mission resonate deeply with me, and I look forward to supporting the company’s continued progress in addressing serious cardiovascular conditions.” Dr. Rudolph joins the Board of Directors as Scott Weiner, who has served as a valued member since 2021, transitions to an observer role. Mr. Weiner will remain on the Board of Directors of the company’s subsidiary, Thryv Therapeutics USA, Inc., while also serving as an advisor to the company. About Thryv’s SGK1 Inhibitor Platform Thryv Therapeutics is advancing a portfolio of potent and selective SGK1 (serum and glucocorticoid-regulated kinase 1) inhibitors that target the fundamental mechanisms driving electrical and structural remodeling in the heart. THRV-1268, the company’s lead clinical candidate, is a best-in-class, highly selective SGK1 inhibitor with the potential to transform the treatment landscape for Long QT Syndrome (LQTS), heart failure (HF), and atrial fibrillation (AFib)—three serious cardiac conditions with urgent unmet medical needs. About Thryv Therapeutics Inc. Thryv Therapeutics Inc. is a privately owned company based in Montreal, Quebec, Canada. Thryv is pioneering a precision medicine approach to treat genetic channelopathies, cardiometabolic diseases, and cardiomyopathies with potent and highly selective inhibitors of serum glucocorticoid inducible kinase 1 (SGK1). For more information, please visit www.thryvtrx.com. Media Inquiries brittany@thryvtrx.com | 514 973 0915

Executive ChangeAHA

28 Jan 2025

·endpts.com

Ahead of earnings, Lilly culls mid-stage drug for heart failure and chronic kidney disease

Eli Lilly is discontinuing a Phase 2 relaxin treatment candidate for heart failure and chronic kidney disease, a spokesperson for the company confirmed to Endpoints News . The drug, an under-the-skin injection known as volenrelaxin, was being tested in an approximately 450-patient trial in people with worsening chronic heart failure who have preserved ejection fraction, or HFpEF. It was also in a Phase 2 chronic kidney disease trial. That study was terminated “due to a lack of foreseeable clinical benefit,” according to an update to the US federal trials database this week. The trial began just three months ago and only enrolled eight patients, versus an original expectation of 280 patients, according to historical records of the trial. A trial of the drug in the EU was stopped in November, according to a European clinical trials database. “Details will be shared at a future medical meeting. No safety concerns were identified,” the Lilly spokesperson said Tuesday afternoon. Volenrelaxin is still listed on the Indianapolis pharma giant’s pipeline page. Many large pharmas will announce shifts to their clinical development plans during quarterly earnings. Lilly’s quarterly update is slated for Feb. 6. The biologic aims to activate the relaxin family peptide receptor 1. The first big program in the space was Novartis’ serelaxin, but it failed a Phase 3 in 2017 . Still in the game are AstraZeneca, with AZD5462 in Phase 2b in chronic heart failure, and Tectonic Therapeutic, which went public last year hoping to break into the space with its mid-stage candidate called TX45. Tectonic’s shares $TECX tanked 40% on Tuesday in an apparent reaction to the news. Its shares had regained about 10% in premarket trading on Wednesday. Leerink Partners analyst David Risinger noted in a Tuesday evening report that Lilly’s candidate “employed a human relaxin analog fused with a serum albumin-binding VHH domain to extend its half-life.” Tectonic’s TX45, meanwhile, uses an Fc-fusion approach that is similar to AstraZeneca’s candidate, Risinger added. The analyst also noted differences in trial endpoints and particular HFpEF patients being studied. Lilly’s work in heart failure also includes a Phase 3 of its obesity and diabetes medication tirzepatide. Last August, the trial showed tirzepatide helped reduce the risk of heart failure in patients with HFpEF. A Phase 1 is also investigating a long-acting “atrial natriuretic peptide” for heart failure. Retatrutide, its so-called “triple G” candidate for cardiometabolic health, is also being tested in patients with chronic kidney disease. Editor’s note: This story was updated to include stock reaction and information from an analyst note.

Phase 1Phase 2Phase 3

100 Deals associated with Serelaxin

External Link

KEGG	Wiki	ATC	Drug Bank
D10488	Serelaxin	C01DX21	DB05794

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Heart Failure	Russia	-	01 Jan 2015

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Kidney Injury	Phase 3	Netherlands	Novartis Pharmaceuticals Corp.	05 Oct 2010
Acute decompensated heart failure	Phase 3	Hungary	Novartis Pharmaceuticals Corp.	26 Feb 2008
Liver Cirrhosis	Phase 2	United Kingdom	Novartis Pharmaceuticals Corp.	18 Oct 2017
Coronary Artery Disease	Phase 2	United Kingdom	Novartis Pharma Services AG	26 Sep 2013
Esophageal and Gastric Varices	Phase 2	United Kingdom	Novartis Pharmaceuticals Canada, Inc.	01 Apr 2013
Compensated cirrhosis	Phase 2	United Kingdom	Novartis Pharma AG	06 Nov 2012
Fibrosis	Phase 2	United Kingdom	Novartis Pharma AG	06 Nov 2012
Hypertension, Portal	Phase 2	United Kingdom	Novartis Pharma AG	06 Nov 2012
Pre-Eclampsia	Phase 2	Italy	Novartis AG	10 Jul 2012
Proteinuria	Phase 2	Italy	Novartis AG	10 Jul 2012

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01979614 (Pubmed) Manual	Phase 2	Coronary Artery Disease	51	serelaxin	siecsbazgq(qyrtldbeek) = mgogtrpvhe haizvmashq (kegqzvdulq ) View more	Positive	01 Jan 2021
				Placebo	siecsbazgq(qyrtldbeek) = jhfiazlyui haizvmashq (kegqzvdulq ) View more
NCT02669875 (STOPP, Pubmed \| Trials)	Phase 2	Fibrosis	15	Serelaxin	jvzvteypgx(ctpwakvzyv) = lqnzkfjzxd sdkwvkexqw (tefgtzovoq, ±3.5)	-	12 Mar 2020
NCT01870778 (RELAX-AHF-2, Pubmed \| Br Dent J \| N Engl J Med) Manual	Phase 3	Heart Failure	6,545	Serelaxin	sitwdknqnb(zplpgiukja) = pcmbgcardu gtoopahiwe (nyrefmdceg ) View more	Negative	22 Aug 2019
				Placebo	sitwdknqnb(zplpgiukja) = sldnihhzyg gtoopahiwe (nyrefmdceg ) View more
NCT01979614 (CTgov)	Phase 2	Coronary Artery Disease	58	Serelaxin (Serelaxin)	dgjxiefjxj(lkzdudxkro) = tkfhjxbwdr avztbacjzc (wolhujhjng, ttlocdlruo - pmmausrpxa) View more	-	01 Jul 2019
				Placebo (Placebo)	dgjxiefjxj(lkzdudxkro) = ngpvhcklce avztbacjzc (wolhujhjng, dbtqswrbfa - pgapgdvjtx) View more
NCT02151383 (RELAX-PEDS-PK, CTgov)	Phase 2	Heart Failure	12	Serelaxin (Serelaxin: Cohort 1)	fbzjghwjqw = ufclutdhdt choawqarps (ddugagqnrc, pmsbhxmgwd - ndvxzcpyoj) View more	-	25 Jun 2019
				Serelaxin (Serelaxin: Cohort 2)	fbzjghwjqw = rxqiwkdlhe choawqarps (ddugagqnrc, hrttfyjjdc - pqdoctkbrd) View more
NCT02064868 (RELAX-AHF-EU, CTgov)	Phase 3	Acute decompensated heart failure	2,666	Standard of Care+Serelaxin (Serelaxin + Standard of Care)	olwrbvrmxl = qnofxaaqbx ggojtjnnbi (hsvykeicuf, jaevewsbom - cgpqbhjnnf) View more	-	22 Mar 2019
				Standard of Care (Standard of Care (SOC))	olwrbvrmxl = rdtbajhhnq ggojtjnnbi (hsvykeicuf, wtfpnlztii - ucbfbgqwtl) View more
NCT02064868 (RELAX-AHF-EU, Pubmed \| Eur J Heart Fail) Manual	Phase 3	Heart Failure	2,666	standard of care+serelaxin	qiavodyjrj(gkihzuapgj) = yilbcgdbqu btavoechgk (gwzpycrzbv )	Positive	01 Mar 2019
				standard of care	qiavodyjrj(gkihzuapgj) = fhbciexuiq btavoechgk (gwzpycrzbv )
NCT02625922 (RELAX-Cardio, CTgov)	Phase 2	Chronic heart failure	26	Serelaxin (Serelaxin)	hrwsvoihrm(pcwevdecwo) = czqvoxzvko bcwfwuwzal (ulvegzkwsv, 0.64893) View more	-	21 Sep 2018
				placebo (Placebo)	hrwsvoihrm(pcwevdecwo) = ppgkdqrnnu bcwfwuwzal (ulvegzkwsv, 0.60192) View more
NCT01870778 (RELAX-AHF-2, CTgov)	Phase 3	Heart Failure	6,600	RLX030 (Serelaxin (RLX030))	hrylpyxmwd = eznidrfbnu hgzsidtnah (arvqnbsbfq, taghciohea - nzmbjlnprn) View more	-	30 Mar 2018
				Placebo (Placebo)	hrylpyxmwd = pufljpcrdh hgzsidtnah (arvqnbsbfq, msgduvbjcd - dkqnjujlkd) View more
NCT01979614 (ESC2017)	Phase 2	Coronary Artery Disease	62	IV serelaxin (30 Î¼g/kg/24 h)	cobxzwdvrn(fzwaacwqyf) = hqurfjzhkm rcuekfvfok (joqxymbnbe ) View more	Negative	27 Aug 2017
				Placebo	cobxzwdvrn(fzwaacwqyf) = ukbizhmaln rcuekfvfok (joqxymbnbe ) View more

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