Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Danazol Capsules
Danazol · 1 trial · 1 indication
Change from baseline score to the week 12 score in the number of letters read on an eye chart in accordance with Early Treatment Diabetic Retinopathy Study (ETDRS) of the Intent to Treat (ITT) population of all treated subjects. A positive number indicates more letters could be read.
| Arm | Type | Description |
|---|---|---|
| Low Dose Danazol | EXPERIMENTAL | Capsules, 0.5 mg/BMI Danazol with dose determined by subject's BMI at baseline, 2 capsules (5 mg, 7.5 mg, or 10 mg) twice daily, for 12 weeks. |
| High Dose Danazol | EXPERIMENTAL | Capsules, 1.0 mg/BMI Danazol with dose determined by subject's BMI at baseline, 2 capsules (5 mg, 7.5 mg, or 10 mg) twice daily, for 12 weeks. |
| Placebo | PLACEBO_COMPARATOR | Gelatin capsules, identical in appearance to the active capsules, filled with pharmaceutical grade lactose and magnesium stearate. |
| Name | Type | Description |
|---|---|---|
| Danazol Capsules | DRUG | - |
| Placebo | DRUG | - |
Study Level Inclusion Criteria: 1. Subject is willing and able to provide informed consent for study participation 2. Male or female 18 years or older with Type 1 or 2 diabetes mellitus \[defined as a self-report of diabetes accompanied by treatment (insulin or diet) or a history of fasting plasma ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901 |
| 4D Molecular Therapeutics, Inc. | FDMT | 2 | PHASE3 | 4D-150, EYELEA |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE3 | Aflibercept |
| Hoffmann-La Roche | RHHBY | 6 | PHASE3 | Ranibizumab, Susvimo, RO7497372, RO7823653, Faricimab |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | MK-8748 |
| AbbVie, Inc. | ABBV | 2 | PHASE2 | Surabgene Lomparvovec |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | ONS-5010 |
| Kodiak Sciences, Inc. | KOD | 1 | PHASE3 | Tabirafusp tedromer |
| Alvotech | ALVO | 1 | PHASE3 | AVT29 |
| Kiora Pharmaceuticals, Inc. | KPRX | 1 | PHASE2 | KIO-104 |
| REGENXBIO, Inc. | RGNX | 1 | PHASE2 | RGX-314 |
| BioAge Labs, Inc. | BIOA | 1 | PHASE2 | BGE-102 |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU200 |
| Surrozen Inc | SRZN | 1 | PHASE1 | SZN-8141 |
| Adverum Biotechnologies, Inc. | ADVM | 1 | - | ADVM-022 |
| Bayer | BAYRY | 1 | - | Aflibercept |