Last reviewed 2026-05-25 · How we verify

Xepol

Calliditas Therapeutics AB · Phase 1 active Small molecule ✓ Verified May 2026

Xepol is a Small molecule drug developed by Calliditas Therapeutics AB. It is currently in Phase 1 development.

Xepol is a human immunoglobulin being studied for its efficacy and safety in treating Post Polio Syndrome (PPS). The clinical trial, NCT00160082, is a randomized, two-arm study investigating the effects of Xepol in subjects with PPS.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% 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	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+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	Xepol
Sponsor	Calliditas Therapeutics AB
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Efficacy and Safety of Xepol (Human Immunoglobulin) in Subjects With Post-Polio Syndrome (PPS) (NA)

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:

Xepol CI brief — competitive landscape report
Xepol updates RSS · CI watch RSS
Calliditas Therapeutics AB portfolio CI

Frequently asked questions about Xepol

What is Xepol?

Xepol is a Small molecule drug developed by Calliditas Therapeutics AB.

Who makes Xepol?

Xepol is developed by Calliditas Therapeutics AB (see full Calliditas Therapeutics AB pipeline at /company/calliditas-therapeutics-ab).

What development phase is Xepol in?

Xepol is in Phase 1.

Manufacturer: Calliditas Therapeutics AB — full pipeline
Therapeutic area: All drugs in Other

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing