Last reviewed 2026-06-02 · How we verify

Autologous thyTreg

Rafael Correa-Rocha · Phase 1 active Biologic ✓ Verified Jun 2026 Quality 0/100

Autologous thyTreg is a Biologic drug developed by Rafael Correa-Rocha. It is currently in Phase 1 development. Also known as: thyTreg cells.

Autologous thyTreg is a cell therapy intervention being studied in clinical trials for the prevention of complications in heart transplantation. The mechanism of action of autologous thyTreg is unknown, but it may promote the synthesis of hyaline-like cartilage repair tissue.

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	Autologous thyTreg
Also known as	thyTreg cells
Sponsor	Rafael Correa-Rocha
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Prevent Rejection in Heart Transplant Children (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:

Autologous thyTreg CI brief — competitive landscape report
Autologous thyTreg updates RSS · CI watch RSS
Rafael Correa-Rocha portfolio CI

Frequently asked questions about Autologous thyTreg

What is Autologous thyTreg?

Autologous thyTreg is a Biologic drug developed by Rafael Correa-Rocha.

Who makes Autologous thyTreg?

Autologous thyTreg is developed by Rafael Correa-Rocha (see full Rafael Correa-Rocha pipeline at /company/rafael-correa-rocha).

Is Autologous thyTreg also known as anything else?

Autologous thyTreg is also known as thyTreg cells.

What development phase is Autologous thyTreg in?

Autologous thyTreg is in Phase 1.

Manufacturer: Rafael Correa-Rocha — full pipeline
Also known as: thyTreg cells

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