Last reviewed 2026-05-23 · How we verify

TTYP01 single ascending doses

Shanghai Auzone Biological Technology Co., Ltd. · Phase 1 active Small molecule ✓ Verified May 2026

TTYP01 single ascending doses is a Small molecule drug developed by Shanghai Auzone Biological Technology Co., Ltd.. It is currently in Phase 1 development. Also known as: edaravone tablet.

A Phase I study of TTYP01 in healthy adult subjects was conducted to evaluate the pharmacokinetics and safety of single ascending doses of TTYP01. The study involved administering TTYP01 at a dose of 60 mg to healthy adult subjects, in addition to a placebo, as part of a randomized, single-ascending dose study.

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	TTYP01 single ascending doses
Also known as	edaravone tablet
Sponsor	Shanghai Auzone Biological Technology Co., Ltd.
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Study of TTYP01 in Healthy Adult Subjects (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:

TTYP01 single ascending doses CI brief — competitive landscape report
TTYP01 single ascending doses updates RSS · CI watch RSS
Shanghai Auzone Biological Technology Co., Ltd. portfolio CI

Frequently asked questions about TTYP01 single ascending doses

What is TTYP01 single ascending doses?

TTYP01 single ascending doses is a Small molecule drug developed by Shanghai Auzone Biological Technology Co., Ltd..

Who makes TTYP01 single ascending doses?

TTYP01 single ascending doses is developed by Shanghai Auzone Biological Technology Co., Ltd. (see full Shanghai Auzone Biological Technology Co., Ltd. pipeline at /company/shanghai-auzone-biological-technology-co-ltd).

Is TTYP01 single ascending doses also known as anything else?

TTYP01 single ascending doses is also known as edaravone tablet.

What development phase is TTYP01 single ascending doses in?

TTYP01 single ascending doses is in Phase 1.

Manufacturer: Shanghai Auzone Biological Technology Co., Ltd. — full pipeline
Also known as: edaravone tablet

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