Last update 01 Nov 2024

Potassium citrate/Potassium bicarbonate

Last update 01 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Potassium bicarbonate/potassium citrate, Potassium citrate monohydrated/potassium hydrogen carbonate, Potassium hydrogen carbonate/potassium citrate monohydrated

+ [6]

Target-

Mechanism-

Therapeutic Areas

Congenital DisordersEndocrinology and Metabolic DiseaseUrogenital Diseases+ [1]

Active Indication

Acidosis, Renal TubularCystinuria

Inactive Indication-

Originator Organization

Advicenne SA

Active Organization

Advicenne SA

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

EU (30 Apr 2021),

Acidosis, Renal Tubular

RegulationOrphan Drug (EU)

Structure

Molecular FormulaCH2KO3

InChIKeyQNEFNFIKZWUAEQ-UHFFFAOYSA-N

CAS Registry298-14-6

View All Structures (2)

Clinical Trials associated with Potassium citrate/Potassium bicarbonate

NCT04137978 / WithdrawnPhase 2/3

Open Label, Multicentre Study, Evaluating the Safety, Tolerability, Efficacy, Compliance and Acceptability of Alkalising Treatments at Long-term in Patients With Cystinuria

This is an open label, multicentre study, evaluating the safety, tolerability, efficacy, compliance and acceptability of alkalising treatments at long-term in patients with cystinuria.

Start Date01 May 2024

Sponsor / Collaborator

Advicenne SA

NCT04147871 / Not yet recruitingPhase 2/3

A Multicentre, Randomized, Controlled Versus Placebo, Double-blinded, 4 Parallel Arms, Dose-ranging Main Study, to Evaluate the Efficacy, Safety and Tolerability and Acceptability of Repeated Doses of ADV7103, After 7 Days of Treatment, in Patients With Cystinuria, and an Efficacy and Safety Exploratory Study in the Youngest Children.

This is a multicenter, randomized, controlled versus placebo, double-blinded, 4 parallel arms, dose-ranging main study, to evaluate the efficacy, safety and tolerability, and acceptability of repeated doses of ADV7103, after 7 days of treatment, in patients with cystinuria, and an efficacy and safety exploratory study in the youngest children.

Start Date01 Mar 2024

Sponsor / Collaborator

Advicenne SA

NCT03831152 / WithdrawnPhase 3

A Phase 3B Open-Label Extension Of Study B23CS (ARENA 2) Evaluating The Continued Safety And Efficacy Of ADV7103 In Subjects With Primary Distal Renal Tubular Acidosis

Open-label study involving longitudinal assessment of the continued safety, tolerability, and efficacy of ADV7103 in maintaining targeted serum bicarbonate levels, preventing metabolic acidosis, and preventing hypokalemia in the following groups of subjects with primary dRTA:
subjects who participated in Study B23CS and were adherent to the protocol;
subjects ≥ 6 months of age who are living in Europe and did not participate in Study B23CS; and
infants younger than 6 months of age

Start Date20 Dec 2023

Sponsor / Collaborator

Advicenne SA

100 Clinical Results associated with Potassium citrate/Potassium bicarbonate

100 Translational Medicine associated with Potassium citrate/Potassium bicarbonate

100 Patents (Medical) associated with Potassium citrate/Potassium bicarbonate

Literatures (Medical) associated with Potassium citrate/Potassium bicarbonate

01 Nov 2024·Pediatric Drugs

Recent Developments in the Treatment of Pediatric Distal Renal Tubular Acidosis

Review

Author: Boyer, Olivia ; Ould Rabah, Mélissa ; Preka, Evgenia

Distal renal tubular acidosis (dRTA) is characterized by a primary defect in proton secretion by α-intercalated cells of the collecting duct, leading to impaired urine acidification and resulting in metabolic acidosis, hypokalemia, and hypercalciuria. Inherited forms of dRTA are currently associated with variants in five genes (SLC4A1, ATP6V1B1, ATP6V0A4, FOXI1, and WDR72), each being associated with specific extra-renal manifestations. Acquired forms can result from autoimmune diseases or drug side effects. Classical complications include nephrolithiasis, nephrocalcinosis, reduced glomerular filtration rate (GFR), bone demineralization, and growth failure. Treatment focuses on correcting the acid-base imbalance through alkali supplementation (potassium, sodium, or magnesium bicarbonate or citrate) to reduce renal disease progression and promote normal growth and mineralization. Traditional treatments (alkali and potassium supplementation) often suffer from poor adherence due to frequent day and night administrations, gastrointestinal discomfort, and unpleasant taste. A novel investigational drug, ADV7103, which contains potassium citrate and potassium bicarbonate in an extended-release formulation, has recently been approved by the European Medicine Agency (EMA) for dRTA. Recent studies support its use as a first-line treatment, given its efficacy and safety profile.

01 Jul 2023·Nefrología (English Edition)

Bone mineral density and growth changes in patients with distal renal tubular acidosis after two-years treatment with a new alkalizing drug (ADV7103)

Article

Author: Rodriguez Portillo, Mariano ; Guittet, Catherine ; Boyer, Olivia ; Joukoff, Sophie ; Granier, Luc-André ; Bertholet-Thomas, Aurélia ; Manso-Silván, Maria A ; Bacchetta, Justine ; Navas-Serrano, Victor

BACKGROUND AND OBJECTIVESADV7103 is a new prolonged-release treatment for distal renal tubular acidosis (dRTA), containing potassium citrate and potassium bicarbonate. Since acidosis may affect bone mineral contents, the effects of ADV7103 on bone mineral density (BMD) and growth in patients with dRTA over 24 months were evaluated.PATIENTS AND METHODSThirty patients (24 paediatric patients and 6 adults) were included in an open-label extension study after a phase II/III trial. BMD, measured by densitometry, was assessed at baseline and at 24 months. Growth was evaluated throughout the study. Plasma bicarbonate, parathyroid hormone, 25-hydroxy vitamin D, 1,25-dihydroxy vitamin D, bone alkaline phosphatase, calciuria and citraturia, were also determined. Safety and treatment compliance were evaluated as well.RESULTSAfter 24 months of treatment with ADV7103, mean spine BMD z-score values significantly increased as compared with baseline (p=0.024). In adults, spine and whole-body densitometry z-scores showed a significant correlation with plasma bicarbonate levels (r_S=0.82 and r_S=0.97, respectively, p<0.005). There was an increase>0.5 units in z-scores for height and weight in 18% and 36% of the paediatric patients, respectively. With treatment, plasma bicarbonate concentration and calciuria at the different visits were normal in 69-86% and 93-96% patients, respectively. Only nine treatment-related gastrointestinal AEs of mild/moderate severity, were reported in five patients.CONCLUSIONSTwo years of ADV7103 treatment improved growth and increased spine BMD. These results suggest that control of acidosis by ADV7103 treatment improves bone parameters.

01 Dec 2022·Orphanet Journal of Rare DiseasesQ2 · MEDICINE

Lived experiences of patients with distal renal tubular acidosis treated with ADV7103 and of their caregivers: a qualitative study

Q2 · MEDICINE

ArticleOA

Author: Bertholet-Thomas, Aurélia ; Manso-Silván, Maria A ; Acquadro, Michaël ; Guittet, Catherine ; Joukoff, Sophie ; Marrel, Alexia

AbstractBackgroundConsequences of distal renal tubular acidosis (dRTA) on growth, bone and kidney, sometimes associated with hearing loss, may significantly affect quality of life (QoL). This descriptive qualitative study explores QoL linked to dRTA and gathers the impressions of patients with this rare disease (and caregivers) 5 years after enrolment in a clinical study, during which patients were treated with ADV7103, a prolonged-release granule formulation combining potassium citrate and potassium bicarbonate. Semi-structured, one-hour interviews with 6 adult and 13 paediatric patients with a confirmed diagnosis of dRTA and with parents of paediatric patients were performed using an interview guide. Qualitative analysis of anonymized interview transcripts based on grounded theory was conducted.ResultsThe main QoL domains impacted by dRTA and its treatment were education/work, social/family life, and emotional and physical well-being. ADV7103 (administered twice daily) was compared with the standard of care (SoC) taken before study entry (more than twice daily). Patients/parents reported that switching from previous SoC to ADV7103 had changed their lives:

Difficulties at school due to burdensome administrative issues and need to explain disease and treatment affecting all families of paediatric patients (n = 13) disappeared, facilitating parents who had stopped working (to deal with their child’s treatment) to return to work,

Family functioning was improved (n = 18), as travel and holidays became easier to organise and patients/parents stopped thinking about managing treatment daily/nightly, reducing tension in the family or couple,

The emotional burden of disease perceived was relieved (n = 12) in the absence of treatment-related invasive questions from others,

Gastro-intestinal adverse events and taste problems improved with ADV7103 (n = 18) and better compliance led to milder physical impacts and less need to be hospitalised.

The mean satisfaction score with ADV7103 compared to SoC was 9 out of 10 (10 = very satisfied). ADV7103 exceeded or met the expectations of 14 out of 17 patients that commented on that.ConclusionsQualitative interviews show that dRTA and its treatment have a significant impact on QoL of patients and parents and that ADV7103 helps improve daily-life and reduces treatment burden, resulting in greater overall satisfaction of the patients and their families.Trial registrationEU Clinical Trials Register, EudraCT 2013-003828-36 on the 3rd of September 2013.

News (Medical) associated with Potassium citrate/Potassium bicarbonate

03 Jun 2024

·www.biospace.com

Avanzanite Bioscience Reports AKANTIOR® Received Positive CHMP Opinion and Announces Corporate Expansion Into 26 European Countries

CHMP opinion paves the way for Marketing Authorisation approval by the European Commission, currently anticipated in early August 2024. When approved, AKANTIOR will be the first licensed medicinal product for the treatment of acanthamoeba keratitis, a rare, severe eye infection that often results in blindness and eye loss. Phase III ODAK study demonstrated 87% of patients receiving AKANTIOR were cured within a median time of 4 months. AKANTIOR will be Avanzanite’s second commercialized orphan medicine, expanding the company’s pan-European footprint to 26 countries. AMSTERDAM--(BUSINESS WIRE)-- Avanzanite Bioscience B.V. (“Avanzanite” or the “Company”), a commercial-stage specialty pharmaceutical company, solely focused on medicines for rare diseases, announced today that the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) issued a positive opinion recommending Marketing Authorisation of AKANTIOR® (polihexanide) for the treatment of acanthamoeba keratitis (“AK”) in adults and children from 12 years of age. This press release features multimedia. View the full release here: Adam Plich, Founder & CEO, Avanzanite Bioscience B.V. (Photo: Business Wire) Today’s announcement follows Avanzanite’s licensing and supply agreement with SIFI, a leading Italian ophthalmic healthcare company, that was announced in January 2023, granting Avanzanite the exclusive rights to commercialize AKANTIOR in 26 countries in the European Economic Area and Switzerland. Avanzanite’s Founder and CEO, Adam Plich, stated, “Avanzanite is a purpose-driven company whose sole mission is to ensure novel medicines reach patients suffering from rare diseases in every market across Europe and beyond. As such, the CHMP positive opinion takes us one step further in our unwavering pursuit of this important goal. No one facing such a monstrous disease should be left behind.” Mr. Plich added, “Through this strategic partnership, Avanzanite is unlocking access to a potential new treatment for those affected by AK in 26 European countries previously unavailable to SIFI.” This CHMP opinion represents the culmination of more than 15 years of research by SIFI based on a comprehensive data package demonstrating AKANTIOR’s quality, safety, and efficacy. In March 2024, results of the Orphan Drug for Acanthamoeba Keratitis (ODAK) pivotal 135-patient Phase III study were reported and published in Ophthalmology. The trial showed that 86,7% of patients receiving AKANTIOR were cured with a median time to cure of 4,1 months. Furthermore, 66,7% of patients treated with AKANTIOR achieved full vision restoration and only 7,5% required a cornea transplant. Following the CHMP’s recommendation to approve AKANTIOR for the treatment of AK, the European Commission (EC) will make its final Marketing Authorisation approval decision within approximately 2 months (currently expected in early August 2024). Meanwhile, AKANTIOR remains available through a pre-authorisation distribution program which, to date, has facilitated treatment access to more than 180 patients across 12 European countries. Following the successful commercialization of Sibnayal®, AKANTIOR will be the second rare disease medicine commercialized by Avanzanite, expanding the company’s footprint across 26 European countries. In February 2023, Avanzanite announced its exclusive distribution agreement with Paris-based specialty pharmaceutical company Advicenne for Sibnayal, approved in the European Union for the treatment of children and adults with distal renal tubular acidosis (dRTA), a rare genetic or acquired kidney disease. Avanzanite’s dedicated team supplies Sibnayal across 8 countries. ABOUT AVANZANITE BIOSCIENCE: Founded in 2022, Avanzanite is a privately-funded, commercial-stage, specialty pharmaceutical company solely focused on medicines for rare diseases. At Avanzanite we believe all patients should benefit from novel orphan or niche medicines regardless of where they live. Our vision is that no one is left behind when facing a debilitating rare disease. We also believe the people who have dedicated their careers to the research & development of novel orphan or niche medicines deserve to witness their tremendous efforts impacting patients’ lives – the work of these heroes should not lie in vain. We make this happen by acquiring, licensing, or distributing approved or late-stage medicines for rare diseases and commercializing them even where nobody else will. Headquartered in Amsterdam in the Netherlands, Avanzanite has commercial infrastructure and technical operations across Europe. Please visit for additional information. ABOUT ACANTHAMOEBA KERATITIS (AK): AK is a rare, severe, and progressive parasitic corneal infection caused by Acanthamoeba, a free-living amoeba. Urgent medical intervention is required as the disease often leads to blindness and eye loss. AK often requires single or multiple corneal transplant procedures with comparably low graft survival rates. Patients report unbearable pain and extreme light sensitivity and can rarely work or lead normal lives until symptoms resolve, leaving patients with trauma for life. While still very rare, the incidence of AK has grown rapidly in recent years. AK primarily affects contact lens wearers, accounting for 50% of blindness among them. ABOUT AKANTIOR®: AKANTIOR (polihexanide) is an anti-amoebic polymer that has been granted Orphan Drug Designation (ODD) by both the European Medicines Agency ("EMA") and Food and Drug Administration ("FDA") for AK. It acts on both the trophozoites and cysts of the protozoan Acanthamoeba. It is formulated at a unique high 0.8 mg/ml dose strength which makes it possible to administer through a validated and standardized, day-only protocol as monotherapy eye drops in single-dose containers. Polihexanide is also being developed by SIFI for the treatment of fungal keratitis for which indication it also has FDA ODD. View source version on businesswire.com: Contacts Adam Plich, Founder & CEO Avanzanite Bioscience B.V. +31 20 301 21 13 media@avanzanite.com Source: Avanzanite Bioscience B.V. Smart Multimedia Gallery Logo Video My journey with Acanthamoeba Keratitis, Juliette Vila Sinclair Spence, Founder of the Acanthamoeba Keratitis Eye Foundation. Photo Adam Plich, Founder & CEO, Avanzanite Bioscience B.V. (Photo: Business Wire) View this news release and multimedia online at:

Clinical ResultLicense out/inPhase 3Orphan DrugDrug Approval

03 Jun 2024

·www.pharmaceutical-technology.com

CHMP approves backing for first acanthamoeba keratitis treatment

Akantior’s commercialisation rights were acquired by Netherlands-based Avanzanite in January this year. Image credit: Shutterstock / Kateryna Kon. The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has backed approval for Akantior (polihexanide), a potential first medicine to treat acanthamoeba keratitis. Recommended Buyer's Guides Buyer's Guide Leading Guide to Packaging Materials, Containers and Containment Services for the Pharmaceutical Industry Buyer's Guide Leading Guide to Clinical Packaging Companies in contract Manufacturing for the Pharmaceutical Industry The CHMP will now send their recommendation of marketing authorisation – for patients aged 12 years and older with the infection – to the European Commission, with a decision expected in August 2024, according to a 3 June press release. Developed by Italian ophthalmic healthcare company SIFI , Akantior’s commercialisation rights were acquired by Netherlands-based Avanzanite in January this year. The licensing and supply agreement includes 26 countries in the European Economic Area and Switzerland. Acanthamoeba keratitis is an eye infection caused by an Acanthamoeba amoeba. The microorganism infects the cornea, leading to possible vision loss and blindness. The infection, which usually affects contact lens wearers, is treated off-label via various combinations of antiseptic and antifungal agents and, according to Avanzanite, by conducting corneal transplants. Akantior is an anti-amoebic polymer that works on both forms of Acanthamoeba in the eye – the mobile trophozoites and the infective cysts. The drug is administered as monotherapy eye drops at 0.8mg/ml dose. Akantior’s active substance is polyhexanide. See Also: The tiny pills that may send shockwaves across immunology Roche’s PI3K inhibitor secures breakthrough status in breast cancer The positive CHMP opinion was based on more than 15 years of data, Avanzanite said. This includes a Phase III trial involving 135 patients with the infection. Results from the trial (NCT03274895) showed that 86.7% of participants receiving the drug were cured with a median time to cure of 4.1 months. Only 7.5% of patients required a cornea transplant, with 66.7% regaining full vision after treatment with Akantior. Avanzanite’s CEO Adam Plich said the positive CHMP opinion takes the company “one step closer” to delivering the medicine to patients with the rare disease. Akantior has been awarded orphan drug status by both the EMA and the US Food and Drug Administration (FDA) – meaning the company has enjoyed a suite of pre-market benefits and could be eligible for market exclusivity in the regions if approved. In February 2023, Avanzanite announced an exclusive distribution agreement with French pharma company Advicenne for distal renal tubular acidosis (dRTA) treatment Sibnayal (potassium hydrogen carbonate / potassium citrate).

Phase 3License out/inOrphan DrugDrug ApprovalClinical Result

28 Feb 2023

·www.biospace.com

Avanzanite Bioscience Partners With Advicenne to Commercialize Sibnayal® For the Treatment of Rare Kidney Disease in Germany, Austria, Switzerland and Greece

Advicenne agreement further validates Avanzanite’s unique business model and establishes it as the go-to commercialization partner for medicines treating rare diseases across Europe Avanzanite now transitioning to sales execution with the first anticipated commercial launch in Germany mid 2023 AMSTERDAM--(BUSINESS WIRE)-- Avanzanite Bioscience B.V. (“Avanzanite” or the “Company”), a specialty pharmaceutical company offering end-to-end commercialization and distribution partnerships with research-based biopharmaceutical originators, announced today that it has signed an exclusive distribution agreement with Paris-based specialty pharmaceutical company Advicenne for a medicinal product approved by the European Commission for the treatment of distal Renal Tubular Acidosis (dRTA). This press release features multimedia. View the full release here: Adam Plich, CEO & Founder (Photo: Business Wire) Avanzanite’s Founder and CEO, Adam Plich, stated, “Today’s announcement is in lock-step with our purpose – both ethical and economic – of delivering novel medicines to patients suffering from rare diseases into markets across Europe and unlocking revenue potential for Advicenne.” Mr. Plich continued, “Since our formal corporate launch just a couple months ago, today’s announcement with Advicenne further validates our unique business model. With this partnership, we are now safely moving beyond platform validation, into a phase of execution and gaining critical mass through pipeline expansion.” dRTA is a rare and serious kidney disease in which acid builds up in the blood. This leads to a range of symptoms including hearing loss and stunted growth in children, as well as vomiting, kidney stones and lack of alertness. The disease also causes levels of potassium in the blood to fall, which can lead to muscle weakness and paralysis. “We too are on a mission of delivering this important new medicine to as many dRTA patients across Europe as possible,” stated Didier Laurens, Chief Executive Officer of Advicenne. “We consider that Avanzanite’s business model is tailor made for companies like Advicenne and will surely help us successfully commercialize our product in European markets where it would have taken time to build expertise with regard to pricing and reimbursement, physician engagement and distribution footprint,” Mr. Laurens concluded. Avanzanite is advancing discussions with several other biopharmaceutical companies seeking to enter the European market to expand its portfolio breadth. Given the high number of investigational drugs in development for rare diseases, Avanzanite envisions significant opportunity to expand patient access and optimize value creation for originators. Avanzanite sees its near-term growth opportunity in late-stage or approved ultra- or other overlooked orphan medicines. Mr. Plich concluded, “We’ve cracked the code in deciphering this tricky landscape, and now, with Advicenne as a partner, in addition to our initial strategic partnership with SIFI, we are ready to take our transformational model to the next level by bringing new medicines to patients with rare diseases.” ABOUT AVANZANITE BIOSCIENCE: Avanzanite is a commercial-stage pharmaceutical company on a mission to redefine the commercialization of orphan medicines to improve patient access across Europe and beyond. Derived from the word ‘Tanzanite’ – one of the rarest and most underappreciated gemstones on earth – Avanzanite was formed to capitalize on two primary objectives, one economic, and one humanitarian. The economic goal is to offer end-to-end commercialization and distribution partnerships to research-based biopharmaceutical originators to unlock the full value of their orphan medicines in European markets; this is the unique expertise and core competency of the Avanzanite team through its decades of operating experience navigating this area. Equally important, the Company's humanitarian goal stems from its commitment to enabling access to novel medicines for patients who suffer from orphan diseases regardless of where in Europe they live. Go to for additional information. ABOUT ADVICENNE. Advicenne (Euronext: ALDVI) is a specialty pharmaceutical company founded in 2007, specializing in the development of innovative treatments in Nephrology. Its lead product (ADV 7103) has received its Marketing Approval for distal renal tubular acidosis in EU and the UK. ADV 7103 is currently in late-stage development in cystinuria in Europe and in dRTA and cystinuria in the US. Headquartered in Paris, Advicenne, listed on the Euronext Paris stock exchange since 2017, has now been listed on Euronext Growth Paris since its transfer on March 30, 2022. For additional information see: View source version on businesswire.com: Contacts Avanzanite Bioscience B.V. +31 20 301 21 13 investors@avanzanite.com media@avanzanite.com Source: Avanzanite Bioscience B.V. Smart Multimedia Gallery Logo Photo Adam Plich, CEO & Founder (Photo: Business Wire) View this news release and multimedia online at:

License out/inDrug Approval

100 Deals associated with Potassium citrate/Potassium bicarbonate

External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Acidosis, Renal Tubular	EU	Advicenne SA	30 Apr 2021
Acidosis, Renal Tubular	NO	Advicenne SA	30 Apr 2021
Acidosis, Renal Tubular	IS	Advicenne SA	30 Apr 2021
Acidosis, Renal Tubular	LI	Advicenne SA	30 Apr 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Cystinuria	Phase 3	FR	Advicenne SA	01 Mar 2024
Cystinuria	Phase 3	BE	Advicenne SA	01 Mar 2024
Acidosis, Renal Tubular	Preclinical	CA	Advicenne SA	20 Sep 2021
Acidosis, Renal Tubular	Preclinical	US	Advicenne SA	20 Sep 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ERA2023	Not Applicable	Acidosis, Renal Tubular	-	Sibnayal ®	mfcpicpayv(xuahvnhgrx) = -0.6±1.0 to -0.3±0.9 p = 0.04 gdiuotcjur (baglcrhqpx ) View more	-	14 Jun 2023
NCT03644706 (ARENA2, ASN2021)	Phase 3	Acidosis, Renal Tubular	3	ADV7103	(ijdnwmdfdm) = One patient reported dyspepsia at 8 months on ADV7103 but resolved with symptomatic treatment sgdzcwvgii (fuwdyepdte )	Positive	27 Oct 2021
NCT03644706 (ARENA2, ASN2021)	Phase 3	Acidosis, Renal Tubular	3	ADV7103		Positive	27 Oct 2021
ERA2020	Not Applicable	Acidosis, Renal Tubular	-	ADV7103	(euoicqnsgz) = rtuatoxjdf uwaotkthph (xdopygfebd ) View more	-	06 Jun 2020

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