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ATB-346 low dose
ATB-346 low dose is a NSAID Small molecule drug developed by Antibe Therapeutics Inc.. It is currently in Phase 2 development for Treatment of osteoarthritis. Also known as: Active comparator.
ATB-346 low dose is a nonsteroidal anti-inflammatory drug (NSAID) that selectively targets COX-2 to reduce gastrointestinal toxicity.
ATB-346 is a small molecule being studied as a potential treatment for osteoarthritis. It is being investigated in a double-blind, placebo-controlled Phase 2B study to assess its efficacy and safety in patients with osteoarthritis.
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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 | ATB-346 low dose |
|---|---|
| Also known as | Active comparator |
| Sponsor | Antibe Therapeutics Inc. |
| Drug class | NSAID |
| Target | COX-2 |
| Modality | Small molecule |
| Therapeutic area | Pain |
| Phase | Phase 2 |
Mechanism of action
By selectively inhibiting COX-2, ATB-346 low dose aims to reduce inflammation and pain while minimizing the risk of gastrointestinal side effects associated with traditional NSAIDs. This is achieved through a proprietary prodrug that is rapidly converted to its active form, allowing for targeted COX-2 inhibition.
Approved indications
- Treatment of osteoarthritis
Common side effects
- Gastrointestinal upset
Key clinical trials
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:
- ATB-346 low dose CI brief — competitive landscape report
- ATB-346 low dose updates RSS · CI watch RSS
- Antibe Therapeutics Inc. portfolio CI
Frequently asked questions about ATB-346 low dose
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Related
- Drug class: All NSAID drugs
- Target: All drugs targeting COX-2
- Manufacturer: Antibe Therapeutics Inc. — full pipeline
- Therapeutic area: All drugs in Pain
- Indication: Drugs for Treatment of osteoarthritis
- Also known as: Active comparator
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing