Table 3.
Evaluation of ChemAP’s approval prediction performance using drugs listed in an external dataset. ‘A’ denotes an ‘Approval’ and ‘U’ denotes an ‘Unapproval’.
| Name | Status | FDA-approved use or reason for clinical failure | ChemAP prediction |
|---|---|---|---|
| Ogsiveo | A | Adults with progressing desmoid tumors who require systemic treatment. | A |
| Agamree | A | To treat Duchenne muscular dystrophy. | A |
| Velsipity | A | Moderately to severely active ulcerative colitis in adults. | A |
| Exxua | A | To treat major depressive disorder. | A |
| Litfulo | A | Severe alopecia areata in both adults and adolescents as young as 12. | A |
| Miebo | A | Signs and symptoms of dry eye disease. | A |
| Veozah | A | Moderate to severe hot flashes caused by menopause. | A |
| Daybue | A | To treat Rett syndrome. | A |
| Zavzpret | A | To treat migraine. | A |
| Filspari | A | Proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression. | A |
| Orserdu | A | ER-positive, HER2-negative, ESR1-mutated, advanced/metastatic breast cancer with disease progression following at least one line of endocrine therapy. | A |
| Fabhalta | A | To treat paroxysmal nocturnal hemoglobinuria. | U |
| Truqap | A | Breast cancer that meets certain disease criteria. | U |
| Augtyro | A | ROS1-positive non-small cell lung cancer. | U |
| Vanflyta | A | Regimen for newly diagnosed acute myeloid leukemia that meets criteria. | U |
| Posluma | A | Positron emission tomography imaging in patients with prostate cancer. | U |
| Paxlovid | A | Mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19. | U |
| Joenja | A | Activated phosphoinositide 3-kinase delta syndrome. | U |
| Skyclarys | A | To treat Friedrich’s ataxia. | U |
| Jaypirca | A | Relapsed or refractory mantle cell lymphoma in adults who have had at least two lines of systemic therapy, including a BTK inhibitor. | U |
| Lufotrelvir | U | Clinical failure due to adverse events (NCT05780541). | U |
| Zandelisib | U | Clinical failure due to adverse events (NCT03768505). | U |
| Alpelisib | U | Clinical failure due to adverse events (NCT03601507). | U |
| AMG 337 | U | Clinical failure due to lack of efficacy (NCT03132155). | U |
| Evobrutinib | U | Clinical failure due to lack of efficacy (NCT02975349). | U |
| Linperlisib | U | Clinical failure due to lack of efficacy (NCT05676697). | U |
| H3B-8800 | U | Clinical failure due to lack of efficacy (NCT02841540). | A |
| Gamcemetinib | U | Clinical failure due to lack of efficacy (NCT04947579). | A |