Kiklin capsules

Astellas Pharma Inc · Phase 2 active Small molecule

Kiklin capsules is a Small molecule drug developed by Astellas Pharma Inc. It is currently in Phase 2 development. Also known as: ASP1585, ILY101, AMG223, bixalomer.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

• Baseline phase 2 → approval rate +15.3pp
  Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Kiklin capsules
Also known as	ASP1585, ILY101, AMG223, bixalomer
Sponsor	Astellas Pharma Inc
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

• Post-Marketing Surveillance on Long-Term Drug Use of Kiklin (Bixalomer)® Capsules in Patients With Hyperphosphatemia Receiving Peritoneal Dialysis
• Post-marketing Surveillance of Kiklin Capsules in Hemodialysis Patients
• A Study of ASP1585 to Evaluate the Bioequivalence Between ASP1585 Granules and ASP1585 Capsules (PHASE1)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Kiklin capsules CI brief — competitive landscape report
• Kiklin capsules updates RSS · CI watch RSS
• Astellas Pharma Inc portfolio CI

Frequently asked questions about Kiklin capsules

What is Kiklin capsules?

Kiklin capsules is a Small molecule drug developed by Astellas Pharma Inc.

Who makes Kiklin capsules?

Kiklin capsules is developed by Astellas Pharma Inc (see full Astellas Pharma Inc pipeline at /company/astellas).

Is Kiklin capsules also known as anything else?

Kiklin capsules is also known as ASP1585, ILY101, AMG223, bixalomer.

What development phase is Kiklin capsules in?

Kiklin capsules is in Phase 2.

Related

• Manufacturer: Astellas Pharma Inc — full pipeline
• Also known as: ASP1585, ILY101, AMG223, bixalomer