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Label indication Use estrogen, alone or in combination with a progestogen, at the lowest effective dose and the shortest duration consistent with treatment goals and risks for the individual woman. Re-evaluate postmenopausal women periodically as clinically appropriate to determine whether treatment is still necessary. FDA label
Angeliq · 2 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| Arm 2 | PLACEBO_COMPARATOR | - |
| Arm 1 | EXPERIMENTAL | - |
| Arm 3 | EXPERIMENTAL | - |
| Arm 4 | EXPERIMENTAL | - |
| Arm 5 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) | DRUG | Treatments will be administered daily, orally during the whole treatment period of 16 weeks without a treatment-free interval. |
| Placebo | DRUG | Placebo treatments will be administered daily, orally during the whole treatment period of 16 weeks without a treatment-free interval. |
Inclusion Criteria: * Postmenopausal Korean women suffering from hot flushes Exclusion Criteria: * Standard exclusion criteria for HRT clinical trials had to be obeyed, including current or history of hormone dependent malignant disease, thromboembolic disorders, abnormal cervical smear, undiagno...
Top 9 of 16 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 5 | PHASE3 | Baxdrostat |
| Eli Lilly and Company | LLY | 4 | PHASE3 | Orforglipron, Clazakizumab |
| Alnylam Pharmaceuticals, Inc | ALNY | 2 | PHASE3 | Zilebesiran, ALN-AGT01 RVR |
| Mineralys Therapeutics, Inc. | MLYS | 1 | PHASE3 | lorundrostat |
| United Therapeutics Corporation | UTHR | 1 | PHASE3 | Ralinepag |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE2 | QCZ484, HJB647 |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE2 | iloperidone |
| Opus Genetics, Inc. | IRD | 1 | PHASE1 | OPGx-BEST1 |
| CRISPR Therapeutics AG | CRSP | 1 | PHASE1 | CTX340 |
Angeliq is a small molecule therapy studied in postmenopausal women for vasomotor symptoms and for hypertension. Its clinical program includes a Phase 3 trial in Korean postmenopausal women with vasomotor symptoms and a Phase 3 trial of its effect on blood pressure in postmenopausal hypertensive women.
Angeliq combines drospirenone and 17-beta-estradiol. Drospirenone is a progestin with antimineralocorticoid activity, and 17-beta-estradiol is an estrogen. Together these hormonal components act on estrogen and progesterone receptors, with drospirenone also affecting mineralocorticoid receptor signaling relevant to blood pressure.
Angeliq is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer is the sponsor of the clinical trials evaluating Angeliq in postmenopausal women.
Angeliq is in Phase 3 development. Its clinical program includes completed Phase 3 trials in vasomotor symptoms and in hypertension in postmenopausal women. It is an investigational therapy in these settings and remains in clinical development.
Angeliq has been studied in two completed Phase 3 trials. NCT00651599 evaluated treatment of vasomotor symptoms in Korean postmenopausal women, enrolling 90 participants. NCT00102141 evaluated the effect of Angeliq on blood pressure in postmenopausal hypertensive women, enrolling 750 participants in a randomized, double-blind, placebo-controlled design.