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ATB-346 mid-dose
ATB-346 mid-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 mid-dose is a nonsteroidal anti-inflammatory drug (NSAID) that selectively targets COX-2 to reduce gastrointestinal toxicity.
ATB-346 mid-dose is a nonsteroidal anti-inflammatory drug (NSAID) that selectively targets COX-2 to reduce gastrointestinal toxicity. Used for Treatment of 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 mid-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
ATB-346 mid-dose works by inhibiting the COX-2 enzyme, which is responsible for producing prostaglandins that cause inflammation and pain. By selectively targeting COX-2, ATB-346 mid-dose aims to reduce gastrointestinal toxicity associated with traditional NSAIDs. This mechanism is intended to provide analgesic and anti-inflammatory effects while minimizing the risk of gastrointestinal side effects.
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 mid-dose CI brief — competitive landscape report
- ATB-346 mid-dose updates RSS · CI watch RSS
- Antibe Therapeutics Inc. portfolio CI
Frequently asked questions about ATB-346 mid-dose
What is ATB-346 mid-dose?
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Is ATB-346 mid-dose also known as anything else?
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What does ATB-346 mid-dose target?
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