Last reviewed 2026-05-25 · How we verify

TLC599 HD group

Taiwan Liposome Company · Phase 2 active Small molecule ✓ Verified May 2026

TLC599 HD group is a Small molecule drug developed by Taiwan Liposome Company. It is currently in Phase 2 development. Also known as: 18 mg DSP with 150 µmol PL (1.5 mL).

TLC599 HD group was part of a Phase IIa clinical trial studying the treatment of Osteoarthritis of the Knee. The trial compared TLC599 HD group to TLC599 LD group and Normal Saline.

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	TLC599 HD group
Also known as	18 mg DSP with 150 µmol PL (1.5 mL)
Sponsor	Taiwan Liposome Company
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Phase IIa, Randomized, Double Blinded, Placebo Controlled, Dose Finding Study for TLC599 in OA Patients (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:

TLC599 HD group CI brief — competitive landscape report
TLC599 HD group updates RSS · CI watch RSS
Taiwan Liposome Company portfolio CI

Frequently asked questions about TLC599 HD group

What is TLC599 HD group?

TLC599 HD group is a Small molecule drug developed by Taiwan Liposome Company.

Who makes TLC599 HD group?

TLC599 HD group is developed by Taiwan Liposome Company (see full Taiwan Liposome Company pipeline at /company/taiwan-liposome-company).

Is TLC599 HD group also known as anything else?

TLC599 HD group is also known as 18 mg DSP with 150 µmol PL (1.5 mL).

What development phase is TLC599 HD group in?

TLC599 HD group is in Phase 2.

Manufacturer: Taiwan Liposome Company — full pipeline
Also known as: 18 mg DSP with 150 µmol PL (1.5 mL)

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