Last reviewed 2026-05-24 · How we verify

AlloRx Stem Cells®

Vitro Biopharma Inc. · Phase 1 active Biologic ✓ Verified May 2026 Quality 10/100

AlloRx Stem Cells® is a Biologic drug developed by Vitro Biopharma Inc.. It is currently in Phase 1 development.

AlloRx Stem Cells are a treatment being studied in a clinical trial for Pitt Hopkins Syndrome, a rare genetic disorder. The exact mechanism of AlloRx Stem Cells is unknown, as per the available information from ChEMBL.

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	AlloRx Stem Cells®
Sponsor	Vitro Biopharma Inc.
Modality	Biologic
Phase	Phase 1

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

Safety & Efficacy of AlloRx SC® in PTHS Patients (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:

AlloRx Stem Cells® CI brief — competitive landscape report
AlloRx Stem Cells® updates RSS · CI watch RSS
Vitro Biopharma Inc. portfolio CI

Frequently asked questions about AlloRx Stem Cells®

What is AlloRx Stem Cells®?

AlloRx Stem Cells® is a Biologic drug developed by Vitro Biopharma Inc..

Who makes AlloRx Stem Cells®?

AlloRx Stem Cells® is developed by Vitro Biopharma Inc. (see full Vitro Biopharma Inc. pipeline at /company/vitro-biopharma-inc).

What development phase is AlloRx Stem Cells® in?

AlloRx Stem Cells® is in Phase 1.

Manufacturer: Vitro Biopharma Inc. — full pipeline

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