Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ANA001
Niclosamide · 1 trial · 1 indication
Incidence of Treatment Emergent Adverse Events (TEAEs)
Incidence of Treatment Emergent Serious Adverse Events (TESAEs)
| Arm | Type | Description |
|---|---|---|
| ANA001 | EXPERIMENTAL | Subjects in the ANA001 treatment arm will receive 1,000 mg (4 capsules; 250 mg each) by mouth twice per day for 7 consecutive days with a meal. If the participant requires mechanical ventilation over the course of the study, ANA001 may be administered via nasogastric (NG), percutaneous endoscopic gastrostomy (PEG) or orogastric (OG) tube and, if possible, should be administered with a scheduled nasogastric (NG) or orogastric (OG) feeding. |
| Matching Placebo | PLACEBO_COMPARATOR | Subjects in the comparator arm will receive matching placebo (hydroxypropylmethylcellulose (HPMC)) (4 capsules, by mouth twice a day) for the 7-day treatment duration. |
| Name | Type | Description |
|---|---|---|
| Niclosamide | DRUG | Niclosamide is an antihelmintic with in-vitro antiviral activity |
| Placebo | DRUG | Matching hydroxypropylmethylcellulose HPMC capsules with no active ingredients |
Key Inclusion Criteria: 1. Provide written informed consent prior to performing study procedures 2. Hospitalized. 3. Male or female ≥18 years of age 4. Positive for severe acute respiratory syndrome coronavirus 2 5. Presence of symptoms of lower respiratory tract infection (LRTI) including at least...
Top 9 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | ibuzatrelvir, Nirmatrelvir/ ritonavir, BNT162b2/RIV |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Molnupiravir |
| Invivyd, Inc. | IVVD | 2 | PHASE3 | VYD2311 |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE3 | Tradipitant |
| Moderna, Inc. | MRNA | 2 | PHASE2 | mRNA-1283, mRNA-1273 |
| ImmunityBio Inc | IBRX | 2 | PHASE2 | Nogapendekin alfa inbakicept |
| Traws Pharma, Inc. | TRAW | 1 | PHASE2 | Ratutrelvir |
| GeoVax Labs, Inc. | GOVX | 1 | PHASE2 | GEO-CM04S1 |
| Gilead Sciences, Inc. | GILD | 1 | PHASE2 | Remdesivir |
Niclosamide is being developed by MetaVia Inc. as a small molecule treatment for COVID-19. It is in Phase 2 clinical development for moderate and severe hospitalized COVID-19 patients. The drug is investigational and has not been approved for this use.
MetaVia Inc. (ticker: MTVA) is developing Niclosamide for COVID-19. The company is the sponsor of the clinical program evaluating the drug in hospitalized patients with moderate and severe coronavirus-19.
Niclosamide is in Phase 2 clinical development for COVID-19. The Phase 2 trial has been completed. The drug remains investigational and is not approved for COVID-19.
Niclosamide has been studied in one Phase 2 clinical trial for COVID-19: NCT04603924, titled "Study of Niclosamide in Moderate and Severe Hospitalized Coronavirus-19 (COVID-19) Patients." The trial enrolled 49 participants in the United States and is completed.
No, Niclosamide is not FDA approved for COVID-19. It is an investigational small molecule in Phase 2 development. The Phase 2 trial has been completed, but the drug has not received regulatory approval for this indication.
The Phase 2 trial NCT04603924 was a randomized, double-blind, placebo-controlled study of Niclosamide in moderate and severe hospitalized COVID-19 patients. It enrolled 49 participants aged 18 years and older in the United States. The trial is completed.