Delving into the Latest Updates on Cinacalcet Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

(R)-α-methyl-N-[3-[3-(trifluoromethyl)phenyl]propyl]-1-naphthalenemethane amine, cinacalcet, Cinacalcet HCL

+ [18]

Target

CaSR

Action

agonists

Mechanism

CaSR agonists(Calcium sensing receptor agonists)

Therapeutic Areas

NeoplasmsEndocrinology and Metabolic DiseaseOther Diseases

Active Indication

HyperparathyroidismHyperparathyroidism, PrimaryParathyroid Neoplasms+ [2]

Inactive Indication-

Originator Organization

Amgen, Inc.

Active Organization

Arrotex Pharmaceuticals Pty Ltd.

Amgen Ltd.

Amgen, Inc.

+ [4]

Inactive Organization

Kyowa Hakko Kogyo Co., Ltd.

Mylan NV

Dompe Biotec SpA

+ [3]

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (08 Mar 2004),

HypercalcemiaHyperparathyroidism, Secondary

RegulationOrphan Drug (United States), Priority Review (China), Orphan Drug (Japan)

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Structure/Sequence

Molecular FormulaC22H23ClF3N

InChIKeyQANQWUQOEJZMLL-PKLMIRHRSA-N

CAS Registry364782-34-3

Biofilm-associated infections present a major therapeutic challenge due to reduced antibiotic susceptibility, altered bacterial physiology, and protection by the extracellular polymeric substance (EPS) matrix. In this study, liquid crystalline nanoparticles (LCNPs) were developed as a co-delivery platform for gentamicin (GEN) and the biofilm-modulating quorum sensing inhibitor cinnamaldehyde (CIN) to enhance antibiofilm activity against Pseudomonas aeruginosa PAO1. LCNPs were successfully fabricated using a hydrotrope dilution method, producing nanoparticles with mean diameters of approximately 200-230 nm and negative surface charge. Co-loading of GEN and CIN resulted in high encapsulation efficiency, particularly for CIN (∼90%), although increasing hydrophobic CIN loading influenced nanostructural organisation, particle size distribution, and colloidal stability. Release/recovery studies demonstrated distinct behaviours for the two compounds: GEN showed rapid initial release followed by a plateau in the recovered fraction, whereas CIN showed a non-linear apparent filtrate recovery profile, consistent with its hydrophobicity and association with lipid domains. Antimicrobial evaluation demonstrated that LCNP encapsulation enhanced GEN activity against planktonic P. aeruginosa PAO1 compared with unformulated GEN. CIN reduced biofilm formation at sub-inhibitory concentrations, supporting its role as a biofilm-modulating agent. GEN-CIN co-loaded LCNPs, particularly at a 1:100 ratio, produced enhanced antibiofilm activity compared with individual treatments and unformulated combinations, including marked reductions in biofilm biomass and viable biofilm-associated bacteria. This improved performance may arise from the complementary roles of GEN as a bactericidal antibiotic and CIN as a biofilm-modulating compound, together with LCNP-mediated co-delivery that supports concurrent presentation of both agents within the biofilm treatment environment. Overall, GEN-CIN co-loaded LCNPs improved antibiofilm activity against P. aeruginosa PAO1 under the tested conditions, supporting the potential of LCNP-mediated antibiotic-biofilm modulator co-delivery. However, the study was limited to a single laboratory strain, and higher CIN loading was associated with structural disruption and reduced colloidal stability. Further formulation optimisation, cytotoxicity and biocompatibility assessment, and evaluation against clinical and antibiotic-resistant P. aeruginosa isolates are required to establish broader translational relevance.

01 Aug 2026·PEST MANAGEMENT SCIENCE

Functionalized Fe ₃ O ₄ nanoparticles for mitigating drought and disease in crops and reducing non‐target biotoxicity

Article

Author: Li, Xiang ; Sun, Shaoyang ; Meng, Xiaohan ; Feng, Jianguo ; Wu, Ziyi ; Zhang, Yan

Abstract:

BACKGROUND:

Global agricultural sustainability faces considerable challenges owing to abiotic and biotic stresses, currently developing functional nanomaterials is an important way to alleviate the above stresses. Herein, ferrosoferric oxide (Fe 3 O 4 ) nanoparticles are modified with L‐arginine (Arg) and grafted with cinnamaldehyde (Cin) to prepare smart Fe–Arg–Cin nanoparticles (NPs) for alleviating drought and disease stresses.

RESULTS:

The structure and properties of Fe–Arg–Cin were characterized. Results revealed that the nanoparticles exhibit a uniform size distribution with 6.8% Cin loading. Fe–Arg–Cin NPs can effectively mitigate the inhibitory effects of drought stress on seed germination and seedling growth for rice and wheat. In addition, the in vitro and in vivo antifungal assays demonstrated that Fe–Arg–Cin NPs has potent antifungal activity against rice sheath blight ( Rhizoctonia solani ) and wheat sharp eyespot ( Rhizoctonia cerealis ). Moreover, biosafety evaluation showed that compared with Cin treatment, Fe–Arg–Cin NPs treatment remarkably reduces toxicity to zebrafish, human liver cells and soil microbial communities.

CONCLUSION:

The Fe–Arg–Cin NPs could not only improve the resistance of rice and wheat to drought stress and enhance the control effect against agricultural pathogens, but also ensures safety for non‐target organisms. This platform provides a promising strategy for improving crop resistance under drought and disease conditions. © 2026 Society of Chemical Industry.

01 Aug 2026·LUMINESCENCE

A Sustainable Hybrid (NH ₄ ) ₂ SO₄‐Driven SALLE–Fluorimetric On–Off Integrated Platform for the Determination of Cinacalcet HCl: A Calcium Receptors Sensing Drug in Different Matrices

Article

Author: Saleh, Safaa F. ; Al‐Farhan, Badriah Saad ; Ghazwani, Norah A. ; Hamad, Ahmed Abdulhafez ; Chaudhary, Anis Ahmad ; Ali, Mohamed A. M. ; Mawkili, Wedad ; Ibrahim, Angum M. M.

ABSTRACT:

A sustainable analytical platform was established through the combination of salting‐out assisted liquid–liquid extraction (SALLE) with fluorescence quenching for the trace‐level quantification of cinacalcet hydrochloride (CC•HCl). Ammonium sulfate (approved as a safe food additive) was utilized as the phase‐separating reagent, whereas eosin Y (EY), a biologically safe fluorescent dye, was selected as the sensing probe. Under acetate buffer conditions (pH 4.6), a stable, nonfluorescent ion pair complex was formed between CC•HCl and EY, producing concentration‐dependent quenching responses ( λem = 555 nm). A linear working range of 0.06–1.10 μg/mL was obtained ( r = 0.9998), with detection and quantitation limits reaching 0.0166 and 0.0503 μg/mL, respectively. Full validation was carried out per ICH Q2(R1) guidelines, confirming acceptable accuracy, specificity, and precision. Kinetic characterization was performed through Stern–Volmer modeling ( KSV = 29.13 × 10 12 L·mol −1 ·s −1 and dissociation constant, Kd = 6.90 × 10 −6 M), double logarithmic plots (association constant, Ka = 1.45 × 10 5 L·mol −1 ), Scatchard analysis ( K(Scatchard) = 4.32 × 10 5 M −1 ), and the Langmuir adsorption isotherm ( K(Langmuir) = 8.51 × 10 4 ng/mL), all of which verified a specific, high‐affinity drug–probe interaction. The platform was further applied to tablet uniformity testing and CC•HCl determination in human biological fluids.

44

News (Medical) associated with Cinacalcet Hydrochloride

08 Jul 2026

·www.biospace.com

Amgen recalls almost 1 million bottles of heart failure drug over quality issue

Anamarija Mrkic /Getty Images The discovery of a foreign substance prompted Amgen to voluntarily recall batches of the medicine Corlanor made in Italy. Amgen has recalled almost 1 million bottles of its chronic heart failure drug Corlanor in response to a contamination concern. The FDA attributed Amgen’s action to the presence of a foreign substance. Amgen began the voluntary recall of 934,577 bottles of the 5-mg Corlanor tablets last month. The recalled products are a mix of 14- and 60-tablet bottles of Corlanor. Amgen also recalled an undisclosed number of bottles of 7.5-mg tablets. Expiry dates for the recalled 5- and 7.5-mg tablets range from July 2026 to December 2028. California-based Amgen listed Italy as the country where the medicines were made. The company has international manufacturing facilities in Ireland, the Netherlands and Singapore, but it also works with third-party contract manufacturers. The FDA categorized the action as a Class II recall, indicating that the drug may cause temporary health consequences but the probability of a serious health issue is small. The recall notice lacks information about whether adverse events are linked to the recalled products. Manufacturing FDA rejects Unicycive and Sobi filings over contract manufacturing deficiencies Unicycive Therapeutics and Sobi received complete response letters for kidney disease and gout filings, respectively, after the FDA found fault with their manufacturing partners. June 30, 2026 · 2 min read · Nick Paul Taylor Read more Amgen won FDA approval for Corlanor in 2015. The drug, which Amgen licensed from Servier, reduces the spontaneous pacemaker activity of the cardiac sinus node to slow the patient’s heart rate. In doing so, Corlanor cuts the risk of hospitalization for worsening heart failure. Corlanor represents a minor revenue stream for Amgen. In its first-quarter results, Amgen grouped the medicine with 12 other drugs that generated sales of $315 million collectively. Corlanor was too small a product even early in its lifecycle to have its own line on Amgen’s financial results. The FDA shared details of the Corlanor recall alongside information about issues with another Amgen drug, Sensipar. Amgen has recalled 9,565 bottles of the chronic kidney disease (CKD) drug made in Japan over deviations from current good manufacturing practices. The FDA approved Sensipar in 2004, clearing the drug for use in treating secondary hyperparathyroidism in CKD patients on dialysis. Sensipar is among the products that Amgen grouped with Corlanor in its first-quarter results. The drug, which Amgen sells as Mimpara in Europe, was once among the company’s best-selling products. Sensipar sales exceeded $1 billion in 2013 and peaked close to $1.8 billion in 2018, only to decline significantly after generic copies came to market.

Drug ApprovalAccelerated Approval

06 Jul 2026

·www.fiercepharma.com

Amgen issues recall for close to 1M heart med bottles due to contamination

Amgen has issued a voluntary recall for nearly 1 million bottles of the heart medication Corlanor (ivabradine) due to possible contamination. The nationwide recall was issued by the company on June 4 and was classified by the FDA as a Class II recall on June 23. Amgen took action after a possible foreign substance was discovered, according to FDA records. Two separate notices concerning the action were issued by the regulatory agency, with one citing 934,577 5-mg bottles of Corlanor in 14-tablet and 60-tablet containers. The company also issued a recall for an undisclosed number of 7.5 mg 60-count bottles . All the recalled heart pills were produced in Italy. The drug is typically used to treat chronic heart failure in adults and for children 6 months or older experiencing stable heart failure symptoms caused by an enlarged heart. The company also initiated a nationwide recall of 9,565 bottles of 30-mg, 30-count bottles of Sensipar (cinacalcet), used to treat hyperparathyroidism in dialysis patients and high blood calcium that can be triggered by parathyroid cancer or severe primary hyperparathyroidism. The California drugmaker also issued recalls due to manufacturing deviations for an undisclosed number of 90-mg , 30-count bottles and 60-mg , 30-count bottles of Sensipar, which the FDA has classified as a Class II action. The recalled Sensipar tablets were all manufactured in Japan, and the dates for those recalls posted on the agency’s website are the same as for Corlanor. The recalls fell at the same time Amgen got bad news that European Union regulators recommended its ANCA-associated vasculitis drug Tavneos lose its authorization in the wake of a review that found the drug’s benefits were “no longer proven to outweigh its risks.” A final decision by the European Commission was expected to be handed down soon. Amgen is also bracing for an FDA hearing to address efficacy and safety concerns regarding Tavneos.

13 May 2026

·www.prnewswire.com

U.S. Renal Care Associate Chief Medical Officer Geoffrey A. Block, MD, FASN Awarded 2026 AAKP Medal of Excellence for Lifetime Contributions to Kidney Care

PLANO, Texas, May 13, 2026 /PRNewswire/ -- U.S. Renal Care, the largest privately held and fastest-growing dialysis provider in the nation, proudly announces that its Associate Chief Medical Officer & Senior Vice President of Clinical Research & Medical Affairs, Geoffrey A. Block, MD, FASN, has been awarded the 2026 American Association of Kidney Patients (AAKP) Medal of Excellence, one of the Association's highest honors for kidney healthcare professionals. Founded in 1969 by kidney patients, AAKP is the largest independent kidney patient organization in the nation. Continue Reading AAKP Dr. Geoffrey A. Block, MD, FASN The AAKP Medal of Excellence recognizes local, national, and international leaders who have been at the forefront of advancing kidney care, innovation, and patient care choice. The award honors individuals whose careers reflect an enduring commitment to improving and extending the lives of people living with kidney disease through advocacy, research, innovation, and quality driven treatments that uphold patient dignity and align with patient aspirations. "Dr. Geoffrey Block's career exemplifies the kind of leadership that advances not only clinical care but also the policies shaping kidney health nationwide," said Edward V. Hickey, III, President of the AAKP. "Dr. Block understands that patient interests are the True North in kidney care. Through his contributions to clinical research, global guidelines, and public policy, he has helped bridge the gap between innovation and real-world patient care. His work has strengthened the foundation of evidence-based practice while ensuring that both patient voice and patient insight data remain central to decision-making. AAKP is proud to honor Dr. Block with the Medal of Excellence for his lasting impact on kidney care systems and the patients they serve." This recognition reflects Dr. Block's devotion to transforming how kidney care is delivered and experienced, evidenced by his career spanning more than three‑decades. A physician scientist and internationally renowned leader in nephrology, Dr. Block has authored or contributed to more than 140 peer reviewed studies and has played a pivotal role in bringing some of the most impactful therapies in kidney disease from early research to patient care. Notably, Dr. Block has been among the first nephrologists to enroll patients in several landmark clinical trials and therapeutic innovations, including enrolling the earliest patients in Phase 2 and Phase 3 clinical trials for Cinacalcet, Parsabiv®, Tenapanor, and VAFSEO, while also designing and conducting randomized trials of other practice- changing therapeutics like HIF-PHIs, Sevelamer, and Ferric citrate. The impact of his work is immeasurable. "I'm deeply grateful to the AAKP for this recognition," commented Dr. Block. "Any accomplishments I've been part of are the result of the support and dedication of many people, especially my research team, which has been led by Martha Block for more than 20 years." Today, Dr. Block continues to shape the future of kidney care through his leadership at U.S. Renal Care. In close partnership with Dr. Mary Dittrich, Chief Medical Officer, U.S. Renal Care, and the other esteemed leaders of the organizations Medical Office—including Drs. Gopa Green, Thao Pascual, Michael Rocklin, and Gregory Schlessinger—he is leading industry‑wide efforts to accelerate the safe and effective adoption of innovative therapies for end‑stage kidney disease including VAFSEO, Cinacalcet, and DefenCath and continuing to support the development of novel therapeutics which address important clinical needs. "Dr. Block's career exemplifies what it means to put patients first—advancing science, translating research into compassionate practice, and continuously raising the standard of care," said Mark Caputo, Chairman and CEO, U.S. Renal Care. "We are honored that his lifelong contributions have been recognized by the AAKP and proud to have his leadership within the U.S. Renal Care family." About U.S. Renal Care U.S. Renal Care is the nation's largest privately held and fastest-growing dialysis provider. In partnership with nephrologists, the company cares for more than 37,000 people living with kidney disease across 32 states, offering a range of treatment options, including in-center and home dialysis, to fit each patient's lifestyle and clinical needs throughout their kidney care journey. U.S. Renal Care leads the dialysis industry with the highest percentage of CMS 4- and 5-star rated centers for patient experience and quality of care. Since 2000, the company has advanced clinical excellence, innovation and operational leadership to improve outcomes and patient experience. Learn more at usrenalare.com. SOURCE U.S. Renal Care 21% more press release views with Request a Demo

Phase 3Executive Change

100 Deals associated with Cinacalcet Hydrochloride

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External Link

KEGG	Wiki	ATC	Drug Bank
D03505	Cinacalcet Hydrochloride	H05BX01	DB01012

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Hyperparathyroidism	China	Kyowa Kirin Co., Ltd.	27 Jun 2014
Hyperparathyroidism, Primary	European Union	Amgen Europe BV	22 Oct 2004
Hyperparathyroidism, Primary	European Union	Dompe Biotec SpA	22 Oct 2004
Hyperparathyroidism, Primary	Iceland	Dompe Biotec SpA	22 Oct 2004
Hyperparathyroidism, Primary	Iceland	Amgen Europe BV	22 Oct 2004
Hyperparathyroidism, Primary	Liechtenstein	Dompe Biotec SpA	22 Oct 2004
Hyperparathyroidism, Primary	Liechtenstein	Amgen Europe BV	22 Oct 2004
Hyperparathyroidism, Primary	Norway	Dompe Biotec SpA	22 Oct 2004
Hyperparathyroidism, Primary	Norway	Amgen Europe BV	22 Oct 2004
Hyperparathyroidism, Primary	United Kingdom	Amgen Ltd.	22 Oct 2004
Parathyroid Neoplasms	European Union	Amgen Europe BV	22 Oct 2004
Parathyroid Neoplasms	European Union	Dompe Biotec SpA	22 Oct 2004
Parathyroid Neoplasms	Iceland	Amgen Europe BV	22 Oct 2004
Parathyroid Neoplasms	Iceland	Dompe Biotec SpA	22 Oct 2004
Parathyroid Neoplasms	Liechtenstein	Dompe Biotec SpA	22 Oct 2004
Parathyroid Neoplasms	Liechtenstein	Amgen Europe BV	22 Oct 2004
Parathyroid Neoplasms	Norway	Dompe Biotec SpA	22 Oct 2004
Parathyroid Neoplasms	Norway	Amgen Europe BV	22 Oct 2004
Parathyroid Neoplasms	United Kingdom	Amgen Ltd.	22 Oct 2004
Hypercalcemia	United States	Amgen, Inc.	08 Mar 2004

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03994172 (Osteo-Men, CTgov)	Phase 4	Osteoporosis	40	human parathyroid hormone (PTH) 1-34+Teriparatide+Cinacalcet+Vitamin D3 (Combination Therapy Arm: Teriparatide (TPTD) + the Calcimimetic Cinacalcet)	xegbgrftbs(hxcspjppuu) = dvpbnxdhgx vparznsznw (qlseieacje, 4.6) View more	-	03 Sep 2026
				human parathyroid hormone (PTH) 1-34+Teriparatide+Vitamin D3 (Monotherapy Arm: Teriparatide (TPTD) + Placebo)	xegbgrftbs(hxcspjppuu) = ubdrdiqrlm vparznsznw (qlseieacje, 3.5) View more
NCT00415584 (CTgov)	Phase 1/2	Hypercalcemia \| Hyperparathyroidism, Secondary	4	Cinacalcet HCl	lgaetrehgu(xtxdvbyaea) = daalkjydak aakxhbwaaw (tumbgxnirp, rbqvplenpj - xupmhsjvrj) View more	-	29 Apr 2025
ISN WCN2025	Not Applicable	Hypercalcemia	27	Furosemide with IV fluids	rpizvajuaj(urrxostyot) = ehtdbgvrnh iwspxwyers (qqioycttjo ) View more	Positive	01 Feb 2025
				Salmon calcitonin	-
WCO_IOF_ESCEO2024	Not Applicable	Hyperparathyroidism, Primary	126	Cinacalcet	tgchqetaoa(czasikppoj) = xzusuastdp mkuwjywzrb (gkqoqzlywu ) View more	Positive	11 Apr 2024
NCT02525796 (CTgov)	Phase 2/3	Hyperparathyroidism, Primary	69	eplerenone+Cinacalcet (Eplerenone + Cinacalcet)	ccbmmqqwzk(dugtxcwome) = odcjsqzomv wxzfxeifjl (ynseijorni, raoekgxsff - qqdszyikqm) View more	-	03 May 2023
				amiloride+Cinacalcet (Amiloride + Cinacalcet)	ccbmmqqwzk(dugtxcwome) = ngqmnylfgv wxzfxeifjl (ynseijorni, qibguqgwpr - fodzyytugo) View more
ASN2022	Not Applicable	Hyperparathyroidism, Secondary	414	Cinacalcet (CIN)	pxqxrbnfem(vsxfirjgnl) = gqhpfanxns zqswzhitfn (wgygflxosv )	-	05 Nov 2022
ASN2021	Not Applicable	Hyperparathyroidism, Secondary Maintenance parathyroid hormone (PTH) \| calcium (Ca) \| phosphate (P)	974	Cinacalcet (CIN)	xowcddwldd(ngejqswmnj) = qembpmmqat qojohauzya (csvtetmixq ) View more	Positive	27 Oct 2021
				Etelcalcetide (ETEL)	xowcddwldd(ngejqswmnj) = gzzesehjsr qojohauzya (csvtetmixq ) View more
NCT03123406 (ACTIVE, ERA2021)	Phase 4	Hyperparathyroidism, Secondary \| Chronic Kidney Diseases Maintenance iPTH \| Ca 2+ \| P ... View more	750	Cinacalcet	htoeojahai(gvstffydvi) = decreased significantly compared with their baseline values syuiinftcg (cjkccakyga ) View more	Positive	29 May 2021
				Placebo
ERA2021	Not Applicable	Hyperparathyroidism, Secondary	-	Cinacalcet	olembjaaon(fiipkoxbxb) = regclpbthb rhykzwbftb (ygcqbouixn ) View more	Positive	29 May 2021
				Etelcalcetide	olembjaaon(fiipkoxbxb) = gnmvtpnguw rhykzwbftb (ygcqbouixn ) View more
NCT03027557 (DENOCINA, CTgov)	Phase 3	Hyperparathyroidism, Primary \| Parathyroid Adenoma \| Hyperplasia	46	Cinacalcet 30 mg Tablet+Denosumab Inj 60 mg/ml (Combined Treatment.)	dzlmynpmwr(ymkjkartrf) = fgdlxpbhcx rrdxdwheph (kztvbxfyue, 0.009) View more	-	25 May 2021
				Saline Injection (Placebo) (Placebo)	dzlmynpmwr(ymkjkartrf) = otikvdhwbt rrdxdwheph (kztvbxfyue, 0.007) View more