Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Olumacostat Glasaretil, 7.5% · 3 trials · 1 indication
Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12
Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12
Percentage of subjects who achieved ≥ 2-grade improvement and a grade of 0 or 1 in the investigator global assessment of acne (IGA) from baseline to Week 12 Scoring Criteria for Investigator Global Assessment 0 - Clear skin with no inflammatory or noninflammatory lesions 1. \- Almost clear; rare noninflammatory lesions with no more than one small inflammatory lesion 2. \- Mild severity; greater than Grade 1; some noninflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions) 3. \- Moderate severity; greater than Grade 2; up to many noninflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion 4. \- Severe; greater than Grade 3; up to many noninflammatory and inflammatory lesions, but no more than a few nodular lesions
Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12 in Phase 2a
Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12 in Phase 2a
Percentage of subjects who achieved ≥ 2-grade improvement in the investigator global assessment of acne (IGA) from baseline to Week 12 in Phase 2a Scoring Criteria for Investigator Global Assessment 0 - Clear skin with no inflammatory or noninflammatory lesions 1. \- Almost clear; rare noninflammatory lesions with no more than one small inflammatory lesion 2. \- Mild severity; greater than Grade 1; some noninflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions) 3. \- Moderate severity; greater than Grade 2; up to many noninflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion 4. \- Severe; greater than Grade 3; up to many noninflammatory and inflammatory lesions, but no more than a few nodular lesions
| Arm | Type | Description |
|---|---|---|
| Olumacostat Glasaretil Gel, 5.0% | EXPERIMENTAL | Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks |
| Olumacostat Glasaretil Gel, Vehicle | PLACEBO_COMPARATOR | Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks |
| Olumacostat Glasaretil Gel, Vehicle QD | PLACEBO_COMPARATOR | Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks |
| Olumacostat Glasaretil Gel, Vehicle BID | PLACEBO_COMPARATOR | Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks |
| Olumacostat Glasaretil Gel, 4.0% QD | EXPERIMENTAL | Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks |
| Olumacostat Glasaretil Gel, 7.5% QD | EXPERIMENTAL | Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks |
| Olumacostat Glasaretil Gel, 7.5% BID | EXPERIMENTAL | Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks |
| Phase 1 | EXPERIMENTAL | Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 7 days in healthy volunteers |
| Phase 2a | EXPERIMENTAL | Olumacostat Glasaretil Gel, 7.5%, or Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks |
| Name | Type | Description |
|---|---|---|
| Olumacostat Glasaretil Gel, 5.0% | DRUG | Gel containing Olumacostat Glasaretil |
| Olumacostat Glasaretil Gel, Vehicle | OTHER | Vehicle (placebo) gel |
| Olumacostat Glasaretil | DRUG | - |
| Vehicle | OTHER | - |
| Olumacostat Glasaretil Gel, 7.5% | DRUG | Gel containing Olumacostat Glasaretil |
Inclusion Criteria: * Signed informed consent and, for subjects under legal adult age, signed assent * Age ≥ 9 years * Clinical diagnosis of facial acne vulgaris defined as: * At least 20 inflammatory lesions, and * At least 20 non-inflammatory lesions, and * Investigator Global Assessment o...
Olumacostat Glasaretil is an investigational small molecule being developed for the treatment of acne vulgaris. It is formulated as a 7.5% topical gel. The drug has completed clinical trials, including a Phase 3 study, but it is not approved and remains in clinical development.
Olumacostat Glasaretil is a small molecule that targets acetyl-CoA carboxylase, an enzyme involved in fatty acid synthesis. By inhibiting this enzyme, the drug aims to reduce sebum production, which is a key factor in the development of acne vulgaris.
Olumacostat Glasaretil is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The drug is currently in Phase 3 clinical development for acne vulgaris.
Olumacostat Glasaretil is in Phase 3 clinical development. It has completed three clinical trials, including a Phase 1 safety study, a Phase 2 dose-ranging study, and a Phase 3 efficacy study. The drug is investigational and has not been approved by regulatory authorities.
Olumacostat Glasaretil has completed three clinical trials. These include NCT01936324, a Phase 1 safety study in 114 participants; NCT02431052, a Phase 2 dose-ranging study in 420 participants; and NCT03073486, a Phase 3 study in 744 participants. All trials were conducted in patients with acne vulgaris.
Yes, Olumacostat Glasaretil is also known as DRM01. The drug was referred to as DRM01 in earlier clinical trials, including the Phase 1 study NCT01936324 and the Phase 2 study NCT02431052. The Phase 3 study NCT03073486 uses the name Olumacostat Glasaretil.