Last reviewed 2026-05-29 · How we verify

TSD-001

Lipac Oncology LLC · Phase 1 active Small molecule ✓ Verified May 2026

TSD-001 is a Small molecule drug developed by Lipac Oncology LLC. It is currently in Phase 1 development. Also known as: Proliposomal Intravesical Paclitaxel.

TSD-001 is a small molecule intervention being studied for the treatment of bladder cancer, specifically low-grade, stage Ta, non-muscle invasive bladder cancer. The conditions being studied include bladder cancer cell transitional, non-muscle invasive bladder cancer, bladder cancer, urinary bladder, and transitional cell carcinoma of the bladder.

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	TSD-001
Also known as	Proliposomal Intravesical Paclitaxel
Sponsor	Lipac Oncology LLC
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Proliposomal Intravesical Paclitaxel for Treatment of Low-Grade, Stage Ta, Non Muscle Invasive Bladder Cancer (PHASE1, 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:

TSD-001 CI brief — competitive landscape report
TSD-001 updates RSS · CI watch RSS
Lipac Oncology LLC portfolio CI

Frequently asked questions about TSD-001

What is TSD-001?

TSD-001 is a Small molecule drug developed by Lipac Oncology LLC.

Who makes TSD-001?

TSD-001 is developed by Lipac Oncology LLC (see full Lipac Oncology LLC pipeline at /company/lipac-oncology-llc).

Is TSD-001 also known as anything else?

TSD-001 is also known as Proliposomal Intravesical Paclitaxel.

What development phase is TSD-001 in?

TSD-001 is in Phase 1.

Manufacturer: Lipac Oncology LLC — full pipeline
Also known as: Proliposomal Intravesical Paclitaxel

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