Approval Probability
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Also known as Olumacostat Glasaretil Gel, 7.5%, Olumacostat Glasaretil, Olumacostat Glasaretil Gel, 5.0%, Olumacostat Glasaretil, 5.0%
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, 7.5% is a topical small molecule gel being developed for the treatment of acne vulgaris. It is applied to the skin and is intended to reduce acne lesions. It is an investigational therapy and has not been approved for commercial use.
Olumacostat Glasaretil, 7.5% targets ACACA and ACACB, two acetyl-CoA carboxylase enzymes. It acts as an inhibitor of these targets. By inhibiting ACACA and ACACB, the drug is designed to reduce sebum production in the skin, which is relevant to acne vulgaris.
Olumacostat Glasaretil, 7.5% is being developed by Eli Lilly and Company, which trades under the ticker LLY. Lilly holds the development program for this topical acne candidate.
Olumacostat Glasaretil, 7.5% is in Phase 3 development for acne vulgaris. It is an investigational drug and is not FDA approved. Three clinical trials have been completed, and no trials are currently active.
Three completed trials have studied Olumacostat Glasaretil, 7.5% and related formulations in acne vulgaris. These include the Phase 3 study NCT03073486 with 744 participants, the Phase 2 dose-ranging study NCT02431052 with 420 participants, and the Phase 1 study NCT01936324 with 114 participants.
Yes. Olumacostat Glasaretil, 7.5% is also known as Olumacostat Glasaretil Gel, 7.5%. Related names include Olumacostat Glasaretil, Olumacostat Glasaretil Gel, 5.0%, and Olumacostat Glasaretil, 5.0%. These refer to the same topical gel program at different concentrations.