Last reviewed 2026-04-20 · How we verify

Alpha-Yutac (BISARAMIL)

Phase 2 active Small molecule Quality 24/100

Alpha-Yutac (generic name: BISARAMIL) is a bisaramil drug. It is currently in Phase 2 development.

Alpha-Yutac works by binding to a specific target, but the exact mechanism is not well understood.

Alpha-Yutac (BISARAMIL) is a small molecule drug in the bisaramil class, but details about its target and approved indications are unknown. Its commercial status, including patent status and generic availability, is also unclear. The half-life of Alpha-Yutac is approximately 8.6 hours, but its bioavailability is unknown. Further information about this drug is limited. As a result, its clinical use and safety profile are not well established.

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	BISARAMIL
Drug class	bisaramil
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells have locks on them, and each lock has a unique key. Alpha-Yutac is like a key that fits into one of these locks, but we don't know which lock it is or what it does when it's inside. This binding action is thought to affect the way cells work, but the details are still unclear.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Establishment of Cessation Therapy by Clinical Trials for Subjects With Betel-quid Dependence and Oral Pre-cancer (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:

Alpha-Yutac CI brief — competitive landscape report
Alpha-Yutac updates RSS · CI watch RSS

Frequently asked questions about Alpha-Yutac

What is Alpha-Yutac?

Alpha-Yutac (BISARAMIL) is a bisaramil drug.

How does Alpha-Yutac work?

Alpha-Yutac works by binding to a specific target, but the exact mechanism is not well understood.

What is the generic name of Alpha-Yutac?

BISARAMIL is the generic (nonproprietary) name of Alpha-Yutac.

What drug class is Alpha-Yutac in?

Alpha-Yutac belongs to the bisaramil class. See all bisaramil drugs at /class/bisaramil.

What development phase is Alpha-Yutac in?

Alpha-Yutac is in Phase 2.

Drug class: All bisaramil drugs
Therapeutic area: All drugs in Other

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