Segesterone
Annovera (segesterone) is a small molecule pharmaceutical. Segesterone was first approved as Annovera on 2018-08-10.
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Combinations
Annovera
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ethinyl estradiol
+
Segesterone acetate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ANNOVERA | Mayne Group | N-209627 RX | 2018-08-10 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| annovera | New Drug Application | 2021-01-13 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ETHINYL ESTRADIOL / SEGESTERONE ACETATE, ANNOVERA, MAYNE PHARMA | |||
| 2023-08-10 | NCE | ||
ATC Codes
No data
HCPCS
Code | Description |
|---|---|
| J7294 | Segesterone acetate and ethinyl estradiol 0.15mg, 0.013mg per 24 hours; yearly vaginal system, each |
Clinical
Clinical Trials
34 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pancreatitis | D010195 | EFO_0000278 | K85 | 1 | 1 | 1 | 1 | 1 | 5 |
| Sphincter of oddi dysfunction | D046628 | — | — | — | 1 | — | 1 | ||
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 2 | 1 | 1 | — | 6 | 9 |
| Autistic disorder | D001321 | EFO_0003758 | F84.0 | — | — | 3 | — | — | 3 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | 1 | 1 | — | 1 | 2 |
| Peutz-jeghers syndrome | D010580 | Q85.89 | — | — | 1 | — | 1 | 2 | |
| Irritable bowel syndrome | D043183 | EFO_0000555 | K58 | — | — | 1 | — | — | 1 |
| Abdominal pain | D015746 | R10.9 | — | — | 1 | — | — | 1 | |
| Hereditary nonpolyposis colorectal neoplasms | D003123 | EFO_0007354 | — | — | 1 | — | — | 1 | |
| Pancreatic diseases | D010182 | K86.9 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic pancreatitis | D050500 | EFO_0000342 | K86.1 | 5 | 2 | — | — | — | 5 |
| Healthy volunteers/patients | — | 1 | 1 | — | — | 1 | 2 | ||
| Dyspepsia | D004415 | EFO_0008533 | K30 | 1 | 1 | — | — | — | 1 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | 1 | — | — | — | 1 |
| Obsessive-compulsive disorder | D009771 | EFO_0004242 | F42 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pancreatic intraductal neoplasms | D000077779 | 1 | — | — | — | 1 | 2 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | — | — | — | — | 1 | 1 |
| Adiposity | D050154 | — | — | — | — | 1 | 1 | ||
| Endoscopic retrograde cholangiopancreatography | D002760 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | SEGESTERONE |
| INN | segesterone |
| Description | Segesterone (INN, USAN), also known as 17α-hydroxy-16-methylene-19-norprogesterone or as 17α-deacetylnestorone, is a steroidal progestin of the 19-norprogesterone group that was never marketed. An acetate ester, segesterone acetate, better known as nestorone or elcometrine, is marketed for clinical use. Segesterone acetate produces segesterone as a metabolite.
|
| Classification | Small molecule |
| Drug class | progestins; steroids (androgens, anabolics); antiandrogens |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | C=C1C[C@H]2[C@@H]3CCC4=CC(=O)CC[C@@H]4[C@H]3CC[C@]2(C)[C@@]1(O)C(C)=O |
Identifiers
| PDB | — |
| CAS-ID | 7690-08-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2107778 |
| ChEBI ID | — |
| PubChem CID | 11823650 |
| DrugBank | DB14584 |
| UNII ID | 09Q5UV3747 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
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Variants
Clinical Variant
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Financial
Annovera - TherapeuticsMD
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 81 documents
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Safety
Black-box Warning
Black-box warning for: Annovera
Adverse Events
Top Adverse Reactions
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12 adverse events reported
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