Ella, Ellaone(ulipristal)
Ella, Esmya, Logilia, 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
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| therapeutics | D013812 |
Trade Name
FDA
EMA
Ella, Logilia
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 | 2025-01-31 |
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
95 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 | — | D25 | 2 | 3 | 10 | 9 | 8 | 32 |
| Myofibroma | D047708 | — | — | 2 | 3 | 6 | 6 | 7 | 24 |
| Contraception | D003267 | — | — | 5 | 4 | 3 | 4 | 5 | 21 |
| Emergencies | D004630 | — | — | — | 1 | 4 | 3 | 7 | 14 |
| Hemorrhage | D006470 | MP_0001914 | R58 | 3 | 1 | 4 | 2 | 1 | 10 |
| Postcoital contraception | D044363 | — | — | — | 1 | 3 | 1 | 2 | 6 |
| Infertility | D007246 | EFO_0000545 | — | — | — | — | 1 | 4 | 5 |
| Uterine hemorrhage | D014592 | — | — | 1 | — | 2 | 1 | 1 | 5 |
| Menorrhagia | D008595 | EFO_0003945 | N92.0 | 1 | — | — | 3 | — | 4 |
| Contraception behavior | D003268 | — | — | 1 | — | — | 1 | 1 | 3 |
Show 12 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myoma | D009214 | — | D21 | — | — | 1 | — | 2 | 3 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | 1 | — | — | 1 |
| Fibrosis | D005355 | — | — | — | — | 1 | — | — | 1 |
| Esophageal and gastric varices | D004932 | EFO_0009545 | I85 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Nerve compression syndromes | D009408 | — | — | — | 1 | — | — | — | 1 |
| Charcot-marie-tooth disease | D002607 | EFO_0004148 | G60.0 | — | 1 | — | — | — | 1 |
| Hereditary sensory and motor neuropathy | D015417 | — | G60.0 | — | 1 | — | — | — | 1 |
| Ovulation inhibition | D034445 | — | — | 1 | 1 | — | — | — | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | — | 1 |
| Rupture | D012421 | — | — | — | 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 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pregnancy rate | D018873 | — | — | 1 | — | — | — | — | 1 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | — | N19 | 1 | — | — | — | — | 1 |
| Urogenital abnormalities | D014564 | — | — | 1 | — | — | — | — | 1 |
| Lung transplantation | D016040 | — | — | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pathologic constriction | D003251 | — | — | — | — | — | — | 3 | 3 |
| Biliary tract diseases | D001660 | EFO_0009534 | K83.9 | — | — | — | — | 3 | 3 |
| Female infertility | D007247 | EFO_0008560 | N97 | — | — | — | — | 3 | 3 |
| Stents | D015607 | — | — | — | — | — | — | 2 | 2 |
| Follow-up studies | D005500 | — | — | — | — | — | — | 1 | 1 |
| Pregnancy complications | D011248 | — | — | — | — | — | — | 1 | 1 |
| Chemical and drug induced liver injury | D056486 | EFO_0004228 | — | — | — | — | — | 1 | 1 |
| Endometrial hyperplasia | D004714 | — | N85.0 | — | — | — | — | 1 | 1 |
| Metrorrhagia | D008796 | — | N92.1 | — | — | — | — | 1 | 1 |
| Hyperplasia | D006965 | EFO_0000536 | — | — | — | — | — | 1 | 1 |
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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 | 159811-51-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2103846 |
| ChEBI ID | — |
| PubChem CID | 130904 |
| DrugBank | DB08867 |
| UNII ID | 6J5J15Q2X8 (ChemIDplus, GSRS) |
Target
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Trends
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Safety
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Adverse Events
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697 adverse events reported
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