Last reviewed 2026-05-26 · How we verify

SyB C-0501

SymBio Pharmaceuticals · Phase 1 active Small molecule ✓ Verified May 2026

SyB C-0501 is a Small molecule drug developed by SymBio Pharmaceuticals. It is currently in Phase 1 development. Also known as: bendamustine hydrochloride.

SyB C-0501 is an oral bendamustine being studied in a multicenter, open-label, Phase I trial for patients with advanced solid tumors. The study aims to evaluate the safety and efficacy of SyB C-0501 in this patient population.

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	SyB C-0501
Also known as	bendamustine hydrochloride
Sponsor	SymBio Pharmaceuticals
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

SyB C-0501(Oral Bendamustine) in Patients With Advanced Solid Tumors (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:

SyB C-0501 CI brief — competitive landscape report
SyB C-0501 updates RSS · CI watch RSS
SymBio Pharmaceuticals portfolio CI

Frequently asked questions about SyB C-0501

What is SyB C-0501?

SyB C-0501 is a Small molecule drug developed by SymBio Pharmaceuticals.

Who makes SyB C-0501?

SyB C-0501 is developed by SymBio Pharmaceuticals (see full SymBio Pharmaceuticals pipeline at /company/symbio-pharmaceuticals).

Is SyB C-0501 also known as anything else?

SyB C-0501 is also known as bendamustine hydrochloride.

What development phase is SyB C-0501 in?

SyB C-0501 is in Phase 1.

Manufacturer: SymBio Pharmaceuticals — full pipeline
Also known as: bendamustine hydrochloride

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