Last reviewed 2026-05-27 · How we verify

Tolerogenic Fibroblasts

FibroBiologics · Phase 1 active Biologic ✓ Verified May 2026

Tolerogenic Fibroblasts is a Biologic drug developed by FibroBiologics. It is currently in Phase 1 development.

Tolerogenic Fibroblasts are being studied as a potential treatment for Multiple Sclerosis, specifically Relapsing-Remitting Multiple Sclerosis, as seen in clinical trials such as NCT05080270. The mechanism of Tolerogenic Fibroblasts is currently unknown, but they are related to fibroblast growth factors, which are involved in cell growth and development.

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	Tolerogenic Fibroblasts
Sponsor	FibroBiologics
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Feasibility Study of Tolerogenic Fibroblasts in Patients With Refractory Multiple Sclerosis (EARLY_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:

Tolerogenic Fibroblasts CI brief — competitive landscape report
Tolerogenic Fibroblasts updates RSS · CI watch RSS
FibroBiologics portfolio CI

Frequently asked questions about Tolerogenic Fibroblasts

What is Tolerogenic Fibroblasts?

Tolerogenic Fibroblasts is a Biologic drug developed by FibroBiologics.

Who makes Tolerogenic Fibroblasts?

Tolerogenic Fibroblasts is developed by FibroBiologics (see full FibroBiologics pipeline at /company/fibrobiologics).

What development phase is Tolerogenic Fibroblasts in?

Tolerogenic Fibroblasts is in Phase 1.

Manufacturer: FibroBiologics — full pipeline

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