Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY2452473 · 2 trials · 1 indication
The IIEF EF domain score was the sum of Questions (Q) 1 to Q5 and Q15 of the IIEF self-reported questionnaire. Q1 to Q5 were rated 0 (low/no EF) to 5 (high EF) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF.
| Arm | Type | Description |
|---|---|---|
| 1 milligram (mg) LY2452473 + 5 mg tadalafil | EXPERIMENTAL | - |
| 5 mg LY2452473 + 5 mg tadalafil | EXPERIMENTAL | - |
| 5 mg LY2452473 + placebo | EXPERIMENTAL | - |
| 10 mg tadalafil + placebo | ACTIVE_COMPARATOR | - |
| 5 mg tadalafil + placebo | ACTIVE_COMPARATOR | - |
| LY900010 (particle size #1) | EXPERIMENTAL | Single combination tablet containing 5 mg tadalafil and 5 mg LY2452473 with a smaller particle size (d90 = 10 microns), administered orally, once only. There will be a washout period of at least 7 days between doses of study drug. d90 is a measurement of the distribution of particle widths such that 90% of the particles have a diameter less than the specified value. |
| LY900010 (particle size #2) | EXPERIMENTAL | Single combination tablet containing 5 mg tadalafil and 5 mg LY2452473 with an intermediate particle size (d90 = 25 microns), administered orally, once only. There will be a washout period of at least 7 days between doses of study drug. d90 is a measurement of the distribution of particle widths such that 90% of the particles have a diameter less than the specified value. |
| LY900010 (particle size #3) | EXPERIMENTAL | Single combination tablet containing 5 mg tadalafil and 5 mg LY2452473 with a larger particle size (d90 = 40 microns), administered orally, once only. There will be a washout period of at least 7 days between doses of study drug. d90 is a measurement of the distribution of particle widths such that 90% of the particles have a diameter less than the specified value. |
| Name | Type | Description |
|---|---|---|
| LY2452473 | DRUG | Administered orally, once daily for 12 weeks |
| tadalafil | DRUG | Administered orally, once daily for 12 weeks |
| placebo (tadalafil) | DRUG | Administered orally, once daily for 12 weeks |
| placebo (LY2452473) | DRUG | Administered orally, once daily for 12 weeks |
| LY900010 | DRUG | Administered orally |
Inclusion Criteria include: * Ambulatory men * History of erectile dysfunction of at least 3 months duration * History of incomplete response to any phosphodiesterase type 5 inhibitor (PDE5i) at the maximum tolerated dose within the label * Anticipate having the same female sexual partner throughou...
LY2452473 is an investigational small molecule being studied for the treatment of erectile dysfunction. It has been evaluated in two completed clinical trials, including a Phase 2 study in men with erectile dysfunction. It is not approved for any indication and remains in clinical development.
LY2452473 targets the androgen receptor (AR) and acts as a modulator. By interacting with the androgen receptor, it is designed to influence androgen signaling pathways relevant to erectile function. This mechanism distinguishes it from phosphodiesterase type 5 inhibitors commonly used for erectile dysfunction.
LY2452473 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor of the clinical trials evaluating the drug in erectile dysfunction.
LY2452473 is in Phase 2 clinical development. Two trials have been completed: a Phase 1 bioavailability study and a Phase 2 study in erectile dysfunction. No active trials are currently listed, and the drug is investigational and not approved for any use.
LY2452473 has been studied in two completed trials. NCT01401543 was a Phase 1 bioavailability study of LY2452473 and tadalafil in 24 healthy male volunteers. NCT01160289 was a Phase 2 study of LY900010 in 410 men with erectile dysfunction. Both trials were conducted in the United States.
LY2452473 and LY900010 are related but distinct. LY2452473 is the androgen receptor modulator itself, while LY900010 was the combination product studied in the Phase 2 erectile dysfunction trial NCT01160289. The Phase 1 trial NCT01401543 evaluated LY2452473 with tadalafil.