Ella, Ellaone(ulipristal)
Ella, Esmya, ellaOne (ulipristal) is a small molecule pharmaceutical. Ulipristal was first approved as Ellaone on 2009-05-15. It has been approved in Europe to treat leiomyoma and postcoital contraception. The pharmaceutical is active against progesterone receptor.
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Commercial
Trade Name
FDA
EMA
Ella (generic drugs available since 2017-02-13)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ulipristal acetate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ELLA | HRA Pharma | N-022474 RX | 2010-08-13 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ella | New Drug Application | 2023-02-15 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ULIPRISTAL ACETATE, ELLA, LAB HRA PHARMA | |||
| 2024-06-24 | M-271 | ||
ATC Codes
G: Genito urinary system and sex hormones
— G03: Sex hormones and modulators of the genital system
— G03A: Hormonal contraceptives for systemic use
— G03AD: Emergency contraceptive drugs
— G03AD02: Ulipristal
— G03X: Other sex hormones and modulators of the genital system in atc
— G03XB: Progesterone receptor modulators, sex hormones and modulators of the genital system
— G03XB02: Ulipristal
HCPCS
No data
Clinical
Clinical Trials
67 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leiomyoma | D007889 | HP_0000131 | D25 | 1 | 3 | 5 | 9 | 3 | 21 |
| Contraception | D003267 | 4 | 4 | 2 | 2 | 3 | 15 | ||
| Postcoital contraception | D044363 | — | 1 | 3 | 1 | 1 | 5 | ||
| Infertility | D007246 | EFO_0000545 | — | — | — | 1 | 1 | 2 | |
| Adenomyosis | D062788 | EFO_1001757 | N80.0 | — | 1 | — | 1 | — | 2 |
| Menorrhagia | D008595 | N92.0 | — | — | — | 2 | — | 2 | |
| Contraception behavior | D003268 | — | — | — | 1 | 1 | 2 | ||
| Dysmenorrhea | D004412 | HP_0100607 | N94.6 | — | — | — | 1 | — | 1 |
| Endometriosis | D004715 | EFO_0001065 | N80 | — | — | — | 1 | — | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Uterine hemorrhage | D014592 | — | — | 2 | — | — | 2 | ||
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ovulation inhibition | D034445 | 1 | 1 | — | — | — | 1 | ||
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | — | 1 |
| Female genital diseases | D005831 | EFO_0009549 | N85 | — | 1 | — | — | — | 1 |
| Premenstrual dysphoric disorder | D065446 | F32.81 | — | 1 | — | — | — | 1 | |
| Premenstrual syndrome | D011293 | N94.3 | — | 1 | — | — | — | 1 | |
| Depression | D003863 | F33.9 | — | 1 | — | — | — | 1 | |
| Postmenopause | D017698 | — | 1 | — | — | — | 1 | ||
| Missed abortion | D000030 | O02.1 | — | 1 | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female infertility | D007247 | EFO_0008560 | N97 | — | — | — | — | 2 | 2 |
| Tracheal stenosis | D014135 | — | — | — | — | 1 | 1 | ||
| Unplanned pregnancy | D049168 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | ULIPRISTAL |
| INN | ulipristal |
| Description | Ulipristal acetate is a 20-oxo steroid obtained by acetylation of the 17-hydroxy group of (11beta,17alpha)-17-acetyl-11-[4-(dimethylamino)phenyl]-3-oxoestra-4,9-dien-17-ol (ulipristal). A selective progesterone receptor modulator, which is employed as an emergency contraceptive. It has a role as a contraceptive drug, a progestin and a progesterone receptor modulator. It is a 3-oxo-Delta(4) steroid, a steroid ester, an acetate ester, a 20-oxo steroid and a tertiary amino compound. It is functionally related to an estradiol. |
| Classification | Small molecule |
| Drug class | steriodal compounds acting on progesterone receptors (excluding-gest- compounds) |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CC(=O)[C@@]1(O)CC[C@H]2[C@@H]3CCC4=CC(=O)CCC4=C3[C@@H](c3ccc(N(C)C)cc3)C[C@@]21C |
Identifiers
| PDB | — |
| CAS-ID | 126784-99-4 |
| RxCUI | 1005920 |
| ChEMBL ID | CHEMBL2103846 |
| ChEBI ID | — |
| PubChem CID | 130904 |
| DrugBank | DB08867 |
| UNII ID | 6J5J15Q2X8 (ChemIDplus, GSRS) |
Target
Variants
Clinical Variant
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Financial
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Trends
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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6,985 adverse events reported
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