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TLC-2716 Dose 1
TLC-2716 Dose 1 is a Small molecule drug developed by OrsoBio, Inc. It is currently in Phase 2 development.
TLC-2716 is a small molecule being studied in a Phase 1 clinical trial for its safety, tolerability, and pharmacokinetics in healthy subjects, as well as its potential effects on hypertriglyceridemia and nonalcoholic fatty liver disease. The trial involves administering TLC-2716 Dose 1 to participants, in addition to a placebo, to evaluate its effects.
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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).
| 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 | TLC-2716 Dose 1 |
|---|---|
| Sponsor | OrsoBio, Inc |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Phase 2a Study of Safety, Tolerability, and Efficacy of TLC-2716 in Subjects With Hypertriglyceridemia and NAFLD (PHASE2)
- A Study to Evaluate Single and Multiple Doses of TLC-2716 in Healthy Participants (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:
- TLC-2716 Dose 1 CI brief — competitive landscape report
- TLC-2716 Dose 1 updates RSS · CI watch RSS
- OrsoBio, Inc portfolio CI
Frequently asked questions about TLC-2716 Dose 1
What is TLC-2716 Dose 1?
Who makes TLC-2716 Dose 1?
What development phase is TLC-2716 Dose 1 in?
Related
- Manufacturer: OrsoBio, Inc — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing