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DAS181 COVID-19
DAS181 COVID-19 is a ACE2 receptor decoy / recombinant fusion protein Small molecule drug developed by Ansun Biopharma, Inc.. It is currently in Phase 3 development for COVID-19 (moderate to severe disease).
DAS181 is a recombinant fusion protein that blocks SARS-CoV-2 entry into human cells by targeting the ACE2 receptor on the cell surface.
DAS181 is a recombinant fusion protein that blocks SARS-CoV-2 entry into human cells by targeting the ACE2 receptor on the cell surface. Used for COVID-19 (moderate to severe disease).
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | DAS181 COVID-19 |
|---|---|
| Sponsor | Ansun Biopharma, Inc. |
| Drug class | ACE2 receptor decoy / recombinant fusion protein |
| Target | SARS-CoV-2 spike protein (via ACE2 binding domain) |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | Phase 3 |
Mechanism of action
DAS181 consists of the extracellular domain of human ACE2 fused to the Fc region of human IgG1, functioning as a decoy receptor. It binds to the spike protein of SARS-CoV-2, preventing the virus from attaching to and infecting host cells. This mechanism aims to reduce viral load and disease severity in COVID-19 patients.
Approved indications
- COVID-19 (moderate to severe disease)
Common side effects
- Infusion-related reactions
- Elevated liver enzymes
- Headache
Key clinical trials
- Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study (PHASE3)
- DAS181 for STOP COVID-19 (PHASE2, PHASE3)
- DAS181 for Patients With Severe Hospitalized Flu and SAD-RVs (COVID-19) (PHASE2)
- Worldwide Trends on COVID-19 Research After the Declaration of COVID-19 Pandemic
- DAS181 for Severe COVID-19: Compassionate Use (NA)
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:
- DAS181 COVID-19 CI brief — competitive landscape report
- DAS181 COVID-19 updates RSS · CI watch RSS
- Ansun Biopharma, Inc. portfolio CI
Frequently asked questions about DAS181 COVID-19
What is DAS181 COVID-19?
How does DAS181 COVID-19 work?
What is DAS181 COVID-19 used for?
Who makes DAS181 COVID-19?
What drug class is DAS181 COVID-19 in?
What development phase is DAS181 COVID-19 in?
What are the side effects of DAS181 COVID-19?
What does DAS181 COVID-19 target?
Related
- Drug class: All ACE2 receptor decoy / recombinant fusion protein drugs
- Target: All drugs targeting SARS-CoV-2 spike protein (via ACE2 binding domain)
- Manufacturer: Ansun Biopharma, Inc. — full pipeline
- Therapeutic area: All drugs in Infectious Disease / Virology
- Indication: Drugs for COVID-19 (moderate to severe disease)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing