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QLS-101 ophthalmic solution, 2.0 %
QLS-101 ophthalmic solution, 2.0 % is a Small molecule drug developed by Qlaris Bio, Inc.. It is currently in Phase 2 development. Also known as: QLS-101.
QLS-101 ophthalmic solution, 2.0%, is being studied for its safety and tolerability in treating Normal Tension Glaucoma (NTG), as well as other conditions such as Glaucoma, Ocular Hypertension, and Sturge-Weber Syndrome. QLS-101 is being compared to Timolol maleate PF 0.5% ophthalmic solution in clinical trials.
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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 | QLS-101 ophthalmic solution, 2.0 % |
|---|---|
| Also known as | QLS-101 |
| Sponsor | Qlaris Bio, Inc. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Study to Evaluate Safety and Tolerability of QLS-101 in NTG (PHASE2)
- Safety and Tolerability Study of QLS-101 in Adolescents With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP) (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:
- QLS-101 ophthalmic solution, 2.0 % CI brief — competitive landscape report
- QLS-101 ophthalmic solution, 2.0 % updates RSS · CI watch RSS
- Qlaris Bio, Inc. portfolio CI
Frequently asked questions about QLS-101 ophthalmic solution, 2.0 %
What is QLS-101 ophthalmic solution, 2.0 %?
Who makes QLS-101 ophthalmic solution, 2.0 %?
Is QLS-101 ophthalmic solution, 2.0 % also known as anything else?
What development phase is QLS-101 ophthalmic solution, 2.0 % in?
Related
- Manufacturer: Qlaris Bio, Inc. — full pipeline
- Also known as: QLS-101
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing