Asset profile
AP301 (fiber-iron phosphate binder)
Small molecule
Evidence outlook · lead readout
RESPOND-1 (NCT07030595) · ESRD (End Stage Renal Disease), Chronic Kidney Disease(CKD), Hyperphosphatemia,...
The completed lead evidence is positive, with design limits that temper confidence; the rationale below says which.
RESPOND-1 (NCT07030595): This Phase 3 trial randomly assigned 474 people on dialysis with high blood phosphate to AP301, to sevelamer carbonate, or to a low dose of AP301. It was open-label, so treatment assignment was known throughout. The primary comparison set the AP301 maintenance dose against the low dose over weeks 24 to 27, and serum phosphorus differed by 0.58 mmol/L in favour of the maintenance dose (95% CI 0.47 to 0.69, p<0.001), equivalent to 1.8 mg/dL.
Caveat: this result is taken from a company announcement or a news report of one, not from the trial registry or a peer-reviewed publication. Treat the figures as the sponsor's own statement, not as independently verified evidence.
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Competitive landscape
60 competitors in this universe: 0 direct rivals (same mechanism and indication), 0 same-class, 60 same-indication; 25 further along in development.
| Drug | Stage | Modality | Mechanism | Evidence signal | Reported efficacygraded featured trials |
|---|---|---|---|---|---|
| AP301 (fiber-Iron Phosphate Binder): this drug | Phase 3 | Small molecule | Iron-based intestinal phosphate binder | ||
| Atrasentan (Vanrafia) | Approved | Small molecule | Endothelin A receptor | ||
| Avacopan (Tavneos) | Approved | Small molecule | Complement C5a receptor 1 (C5aR1/CD88) | ||
| Baxdrostat (Baxfendy) | Approved | Small molecule | Aldosterone synthase (CYP11B2) | ||
| Budesonide (targeted-Release) (TARPEYO / Nefecon) | Approved | Small molecule | Glucocorticoid receptor | ||
| Canagliflozin (Invokana) | Approved | Small molecule | SGLT2 | ||
| Dapagliflozin (Farxiga / Forxiga) | Approved | Small molecule | SGLT2 | ||
| Daprodustat (Jesduvroq) | Approved | Small molecule | HIF prolyl hydroxylase (HIF-PH1/2/3) | ||
| Difelikefalin (Korsuva) | Approved | Peptide | Kappa-opioid receptor (agonist, peripherally restricted) | ||
| Empagliflozin (Jardiance) | Approved | Small molecule | SGLT2 | ||
| Etelcalcetide (Parsabiv) | Approved | Peptide | Calcium-sensing receptor (CaSR), allosteric agonist on parathyroid chief cells | ||
| Extended-Release Calcifediol (Rayaldee) | Approved | Small molecule | Vitamin D receptor (VDR), via conversion to calcitriol | ||
| Ferric Carboxymaltose (Injectafer / Ferinject) | Approved | Iron Complex (iv) | Iron repletion | ||
| Ferric Derisomaltose (Monoferric / Monofer) | Approved | Iron Complex (iv) | Iron repletion | ||
| Ferric Pyrophosphate Citrate (Triferic) | Approved | Small molecule | Iron-replacement therapy delivered via dialysate | ||
| Ferumoxytol (Feraheme) | Approved | Nanoparticle | IV iron replacement therapy |
…and 45 more. Research shows the complete landscape.
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Upcoming events
No upcoming readouts on record for this asset.
All registered studies
Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.