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Hyperphosphatemia

18
Pipeline Programs
12
Companies
40
Clinical Trials
6 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
0
5
0
9
3
Early DiscoveryClinical DevelopmentMarket

On Market (1)

Approved therapies currently available

Ardelyx
XPHOZAHApproved
tenapanor
Ardelyx
oral2023
1M Part D

Competitive Landscape

12 companies ranked by most advanced pipeline stage

Akebia Therapeutics
Akebia TherapeuticsCAMBRIDGE, MA
1 program
1
ferric citratePhase 42 trials
Active Trials
NCT05085275Completed289Est. Jan 2024
NCT04922645Completed214Est. Sep 2022
Ardelyx
ArdelyxCA - Fremont
1 program
1
XPHOZAH(tenapanor)Phase 45 trials
Active Trials
NCT07382167Recruiting692Est. Jun 2027
NCT06810167Recruiting25Est. Jun 2027
NCT06460038Recruiting30Est. Mar 2027
+2 more trials
Bayer
BayerLEVERKUSEN, Germany
10 programs
1
2
4
FosrenolPhase 31 trial
FosrenolPhase 31 trial
Lanthanum CarbonatePhase 31 trial
Lanthanum carbonatePhase 31 trial
BAY 77-1931Phase 21 trial
+5 more programs
Active Trials
NCT01955876Completed343Est. Aug 2016
NCT01412398Completed446Est. Sep 2016
NCT01419327Completed3,267Est. May 2019
+7 more trials
Alebund Pharmaceuticals
Alebund PharmaceuticalsChina - Shanghai
3 programs
2
1
AP301Phase 33 trials
AP301Phase 2
AP306Phase 21 trial
Active Trials
NCT06712654Not Yet Recruiting144Est. Dec 2025
NCT06100627Completed32Est. Feb 2024
NCT07030595Completed474Est. May 2025
+1 more trials
Panion & BF Biotech
Panion & BF BiotechTaiwan - Taipei City
2 programs
2
Ferric CitratePhase 31 trial
ferric citratePhase 31 trial
Active Trials
NCT03984760Completed240Est. Feb 2021
NCT01503736Completed183
Fortrea
FortreaDURHAM, NC
1 program
1
AP301Phase 31 trial
Active Trials
NCT06933472Recruiting264Est. Jan 2027
Sandoz
SandozAustria - Kundl
1 program
1
SBR759APhase 31 trial
Active Trials
NCT01069692Completed115
Astellas
AstellasChina - Shenyang
1 program
1
ASP1585Phase 21 trial
Active Trials
NCT00505037Completed156Est. Sep 2008
Baxter International
1 program
systemic dietary instructionN/A1 trial
Active Trials
NCT01329497Unknown50Est. Dec 2012
Baxter
BaxterCosta Rica - Cartago
1 program
systemic dietary instructionN/A
Daiichi Sankyo
Daiichi SankyoChina - Shanghai
1 program
DS-2330b PIBPHASE_11 trial
Active Trials
NCT03305471Completed40Est. Jan 2019
Chugai Pharma
Chugai PharmaJapan - Tokyo
1 program
EOS789PHASE_11 trial
Active Trials
NCT02965053Completed26Est. Aug 2018

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
Ardelyxtenapanor
Akebia Therapeuticsferric citrate
Ardelyxtenapanor
Ardelyxtenapanor
Ardelyxtenapanor
FortreaAP301
Ardelyxtenapanor
Alebund PharmaceuticalsAP301
Ardelyxtenapanor
Ardelyxtenapanor
Akebia Therapeuticsferric citrate
Panion & BF BiotechFerric Citrate
Ardelyxtenapanor
Ardelyxtenapanor
Ardelyxtenapanor

Showing 15 of 40 trials with date data

Clinical Trials (40)

Total enrollment: 12,449 patients across 40 trials

Effect of Tenapanor on the Metagenomics and Metabolomics of Patients With Irritable Bowel Syndrome With Constipation

Start: Feb 2024Est. completion: Dec 202536 patients
Phase 4Completed

Auryxia (Ferric Citrate) Therapy for In-Center and Home Dialysis Participants

Start: Jun 2021Est. completion: Sep 2022214 patients
Phase 4Completed

Study to Evaluate the Use of Tenapanor as Core Therapy in the Treatment of Hyperphosphatemia

Start: Nov 2020Est. completion: Dec 2021333 patients
Phase 4Completed

A Long-Term Study of Tenapanor Alone or in Combination With Sevelamer in Patients With CKD on Dialysis and HP

Start: Jun 2019Est. completion: Jul 2021172 patients
Phase 4Completed

A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in Adults

Start: Jan 2026Est. completion: Jun 2027692 patients
Phase 3Recruiting

A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China

Start: Jun 2025Est. completion: Jan 2027264 patients
Phase 3Recruiting

Assessing Tenapanor as a Treatment of CF-related Constipation.

Start: Jun 2025Est. completion: Jun 202725 patients
Phase 3Recruiting

AP301 Efficacy and Safety in Chinese Dialysis Patients With Hyperphosphatemia

Start: Jun 2023Est. completion: May 2025474 patients
Phase 3Completed

Safety Study of Tenapanor for the Treatment of Pediatric Patients (6 to Less Than 18 Years Old) With IBS-C

Start: Feb 2023Est. completion: Oct 2031150 patients
Phase 3Enrolling By Invitation

Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years

Start: Nov 2022Est. completion: Jun 2026180 patients
Phase 3Recruiting

Ferric Citrate for the Prevention of Renal Failure in Adults With Advanced Chronic Kidney Disease

Start: Mar 2022Est. completion: Jan 2024289 patients
Phase 3Completed

Ferric Citrate for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis

Start: Jun 2019Est. completion: Feb 2021240 patients
Phase 3Completed

A Phase 3 Study of Tenapanor to Treat Hyperphosphatemia in ESRD Patients on Dialysis

Start: Jan 2018Est. completion: Feb 20201,559 patients
Phase 3Completed

A Long-Term Safety Study of Tenapanor for the Treatment of IBS-C

Start: Mar 2016Est. completion: Oct 2017312 patients
Phase 3Completed

An 8-Week Study to Evaluate Tenapanor in the Treatment of Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD)

Start: Jan 2016Est. completion: Jan 2018219 patients
Phase 3Completed

A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C

Start: Dec 2015Est. completion: Oct 2017593 patients
Phase 3Completed

A 12-Week Study With a 4-Week Randomized Withdrawal Period to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of IBS-C

Start: Oct 2015Est. completion: Apr 2017606 patients
Phase 3Completed

Long-term Study in Chronic Kidney Disease (Extension From Study 14817)

Start: Sep 2010Est. completion: Apr 2013123 patients
Phase 3Completed

Study in Chronic Kidney Disease (CKD) Not on Dialysis

Start: Jun 2010Est. completion: Nov 2011143 patients
Phase 3Completed

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Effects of Ferric Citrate in Subjects With End Stage Renal Disease

Start: Jun 2010183 patients
Phase 3Completed

Placebo Versus SBR759 in Lowering Phosphate in Dialysis Patients

Start: Feb 2010115 patients
Phase 3Completed
NCT01514851BayerLanthanum carbonate

Phase III Double-blind Comparative Study of BAY77-1931 (Lanthanum Carbonate) With Calcium Carbonate

Start: Jan 2006Est. completion: May 2006259 patients
Phase 3Completed
NCT01518387BayerLanthanum Carbonate

Open Study of BAY77-1931 (Lanthanum Carbonate) in Continuous Ambulatory Peritoneal Dialysis Patients

Start: Jan 2006Est. completion: Jul 200643 patients
Phase 3Completed

Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy

Start: Feb 2019Est. completion: Jul 2019236 patients
Phase 2/3Completed

A Study to Evaluate Safety, Tolerability and Efficacy of AP306 At Fixed Doses in Patients with Hyperphosphatemia

Start: Apr 2025Est. completion: Dec 2025144 patients
Phase 2Not Yet Recruiting

Tenapanor in Synucleinopathy-Related Constipation

Start: Jan 2025Est. completion: Mar 202730 patients
Phase 2Recruiting

4-Week, Multi-center Dose-Ranging Study for the IBS-C in Pts. 6 to <12 Yrs

Start: Jul 2024Est. completion: Jun 202672 patients
Phase 2Recruiting

A Phase 2 Study to Evaluate the Safety and Efficacy of VS-505(AP301) to Treat Hyperphosphatemia in Hemodialysis Patients

Start: Oct 2020Est. completion: Oct 2022158 patients
Phase 2Completed

A Phase 2 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia on Hemodialysis

Start: Oct 2007Est. completion: Sep 2008156 patients
Phase 2Completed
NCT00767637BayerLanthanum Carbonate

Long-term Treatment on BAY77-1931 (Lanthanum Carbonate) to Measure Lanthanum Concentrations in Bone

Start: Jun 2005Est. completion: Oct 200814 patients
Phase 2Completed
NCT00769496BayerBAY 77-1931

BAY 77-1931 Long-term Extension From Phase II Study

Start: Jan 2005Est. completion: May 2008145 patients
Phase 2Completed

A Pharmacodynamic Effect Study of AP301 in Healthy Volunteers

Start: Jan 2024Est. completion: Feb 202432 patients
Phase 1Completed

An Open-label Study to Evaluate the Pharmacokinetics of Oral Tenapanor in Breast Milk of Lactating Females

Start: Nov 2023Est. completion: May 20247 patients
Phase 1Completed

DS2330b Alone and With Sevelamer in Patients on Chronic Hemodialysis

Start: Aug 2017Est. completion: Jan 201940 patients
Phase 1Completed

A Phase1 Study to Explore the Safety of EOS789 in Patients With Chronic Kidney Disease and Hyperphosphatemia on Hemodialysis

Start: Dec 2016Est. completion: Aug 201826 patients
Phase 1Completed
NCT01053676BayerLanthanum Carbonate

Bioequivalence Study of BAY77-1931 Granule

Start: Jan 2010Est. completion: Apr 201059 patients
Phase 1Completed
NCT01955876BayerLanthanum Carbonate

Fosrenol Post-marketing Surveillance in Japan

Start: Oct 2013Est. completion: Aug 2016343 patients
N/ACompleted
NCT01329497Baxter Internationalsystemic dietary instruction

The Effect of Systemic Dietary Instruction on Management of Plasma Phosphorus Levels in Peritoneal Dialysis (PD) Patients

Start: Jan 2011Est. completion: Dec 201250 patients
N/AUnknown
NCT01412398BayerLanthanum Carbonate

Fosrenol Post-marketing Surveillance for Continuous Cyclic Peritoneal Dialysis in Japan

Start: Apr 2009Est. completion: Sep 2016446 patients
N/ACompleted
NCT01419327BayerLanthanum Carbonate

Fosrenol Post-marketing Surveillance for Hemodialysis in Japan

Start: Mar 2009Est. completion: May 20193,267 patients
N/ACompleted

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

9 late-stage (Phase 3) programs, potential near-term approvals
6 actively recruiting trials targeting 12,449 patients
12 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.