Last reviewed 2026-05-26 · How we verify

TollB-001 tablets

Toll Biotech Co. Ltd. (Beijing) · Phase 1 active Small molecule ✓ Verified May 2026 Quality 0/100

TollB-001 tablets is a Small molecule drug developed by Toll Biotech Co. Ltd. (Beijing). It is currently in Phase 1 development. Also known as: TollB-001.

TollB-001 tablets are a small molecule being studied for the treatment of moderate to severe Rheumatoid Arthritis. The tablets are being tested in a multicenter, randomized, double-blind study with doses of 100mg, 200mg, and 400mg once daily.

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	TollB-001 tablets
Also known as	TollB-001
Sponsor	Toll Biotech Co. Ltd. (Beijing)
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

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:

TollB-001 tablets CI brief — competitive landscape report
TollB-001 tablets updates RSS · CI watch RSS
Toll Biotech Co. Ltd. (Beijing) portfolio CI

Frequently asked questions about TollB-001 tablets

What is TollB-001 tablets?

TollB-001 tablets is a Small molecule drug developed by Toll Biotech Co. Ltd. (Beijing).

Who makes TollB-001 tablets?

TollB-001 tablets is developed by Toll Biotech Co. Ltd. (Beijing) (see full Toll Biotech Co. Ltd. (Beijing) pipeline at /company/toll-biotech-co-ltd-beijing).

Is TollB-001 tablets also known as anything else?

TollB-001 tablets is also known as TollB-001.

What development phase is TollB-001 tablets in?

TollB-001 tablets is in Phase 1.

Manufacturer: Toll Biotech Co. Ltd. (Beijing) — full pipeline
Also known as: TollB-001

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