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Drug ReportsPalovarotene
Palovarotene
Sohonos (palovarotene) is a small molecule pharmaceutical. Palovarotene was first approved as Sohonos on 2023-08-16. It is used to treat heterotopic ossification in the USA. The pharmaceutical is active against retinoic acid receptor gamma.
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Variants
Financial
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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Sohonos
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Palovarotene
Tradename
Company
Number
Date
Products
SOHONOSIpsenN-215559 RX2023-08-16
5 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
sohonosNew Drug Application2023-08-24
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
heterotopic ossification—D009999—
Agency Specific
FDA
EMA
Expiration
Code
PALOVAROTENE, SOHONOS, IPSEN
2030-08-16ODE-439
2028-08-16NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Palovarotene, Sohonos, Ipsen
108641942037-06-08U-3676
116229592037-06-08U-3676
93144392031-08-31U-3676
97890742031-08-31U-3676
102929542031-08-31U-3676
ATC Codes
M: Musculo-skeletal system drugs
— M09: Other drugs for disorders of the musculo-skeletal system in atc
— M09A: Other drugs for disorders of the musculo-skeletal system in atc
— M09AX: Other drugs for disorders of the musculo-skeletal system in atc
— M09AX11: Palovarotene
HCPCS
No data
Clinical
Clinical Trials
11 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myositis ossificansD009221—M61.1132—28
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multiple hereditary exostosesD005097—Q78.6—1———1
ExostosesD005096—M27.8—1———1
OsteophyteD054850—M25.7—1———1
OsteochondromaD015831———1———1
OsteochondromatosisD018216———1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Dry eye syndromesD015352—H04.121————1
Eye diseasesD005128EFO_0003966H441————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePalovarotene
INNpalovarotene
Description
Palovarotene is a stilbenoid.
Classification
Small molecule
Drug classarotinoid derivatives
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC1(C)CCC(C)(C)c2cc(Cn3cccn3)c(/C=C/c3ccc(C(=O)O)cc3)cc21
Identifiers
PDB—
CAS-ID410528-02-8
RxCUI—
ChEMBL IDCHEMBL2105648
ChEBI ID—
PubChem CID10295295
DrugBankDB05467
UNII ID28K6I5M16G (ChemIDplus, GSRS)
Target
Agency Approved
RARG
RARG
Organism
Homo sapiens
Gene name
RARG
Gene synonyms
NR1B3
NCBI Gene ID
Protein name
retinoic acid receptor gamma
Protein synonyms
Nuclear receptor subfamily 1 group B member 3, RAR-gamma
Uniprot ID
Mouse ortholog
Rarg (19411)
retinoic acid receptor gamma (P18911)
Alternate
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 406 documents
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Safety
Black-box Warning
Black-box warning for: Sohonos
Adverse Events
Top Adverse Reactions
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10 adverse events reported
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