Last reviewed 2026-06-02 · How we verify

Allocetra - Safety run-in phase

Kaplan Medical Center · Phase 1 active Small molecule ✓ Verified Jun 2026

Allocetra - Safety run-in phase is a Small molecule drug developed by Kaplan Medical Center. It is currently in Phase 1 development.

Allocetra is being studied in a safety run-in phase as part of a Phase 1/2a clinical trial for the treatment of knee osteoarthritis. The study also involves the treatment of osteoarthritis of the thumb, although the safety run-in phase specifically focuses on knee osteoarthritis.

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	Allocetra - Safety run-in phase
Sponsor	Kaplan Medical Center
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Study of Intra-articular Allocetra in Knee Osteoarthritis (PHASE1, PHASE2)
Intra-articular Allocetra in Osteoarthritis of the 1st Carpo-metacarpal Joint (PHASE1, PHASE2)

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:

Allocetra - Safety run-in phase CI brief — competitive landscape report
Allocetra - Safety run-in phase updates RSS · CI watch RSS
Kaplan Medical Center portfolio CI

Frequently asked questions about Allocetra - Safety run-in phase

What is Allocetra - Safety run-in phase?

Allocetra - Safety run-in phase is a Small molecule drug developed by Kaplan Medical Center.

Who makes Allocetra - Safety run-in phase?

Allocetra - Safety run-in phase is developed by Kaplan Medical Center (see full Kaplan Medical Center pipeline at /company/kaplan-medical-center).

What development phase is Allocetra - Safety run-in phase in?

Allocetra - Safety run-in phase is in Phase 1.

Manufacturer: Kaplan Medical Center — full pipeline

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