Last reviewed 2026-05-27 · How we verify

Keishibukuryogan

Timothy Welty, PharmD · Phase 2 active Small molecule ✓ Verified May 2026

Keishibukuryogan is a Small molecule drug developed by Timothy Welty, PharmD. It is currently in Phase 2 development.

Keishibukuryogan is a Japanese herbal supplement that has been studied as an adjunctive treatment for catamenial epilepsy in adults. It has also been investigated for its potential to alleviate hot flashes and symptoms associated with menopause.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	Keishibukuryogan
Sponsor	Timothy Welty, PharmD
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Catamenial Epilepsy Treatment (PHASE2)
TU 025 Keishi Bukuryo Gan for Post-menopausal Hot Flash Management (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:

Keishibukuryogan CI brief — competitive landscape report
Keishibukuryogan updates RSS · CI watch RSS
Timothy Welty, PharmD portfolio CI

Frequently asked questions about Keishibukuryogan

What is Keishibukuryogan?

Keishibukuryogan is a Small molecule drug developed by Timothy Welty, PharmD.

Who makes Keishibukuryogan?

Keishibukuryogan is developed by Timothy Welty, PharmD (see full Timothy Welty, PharmD pipeline at /company/timothy-welty-pharmd).

What development phase is Keishibukuryogan in?

Keishibukuryogan is in Phase 2.

Manufacturer: Timothy Welty, PharmD — full pipeline
Therapeutic area: All drugs in Other

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