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Drug ReportsAbaloparatide
Tymlos, Eladynos(abaloparatide)
Eladynos, Tymlos (abaloparatide) is a protein pharmaceutical. Abaloparatide was first approved as Tymlos on 2017-04-28. It is used to treat pasteurellaceae, postmenopausal osteoporosis, and postmenopausal osteoporosis in the USA. It has been approved in Europe to treat osteoporosis and postmenopausal osteoporosis. The pharmaceutical is active against parathyroid hormone/parathyroid hormone-related peptide receptor.
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5D
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3M
6M
YTD
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FDA approval date
EMA approval date
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Study first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
musculoskeletal diseasesD009140
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Tymlos
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Abaloparatide
Tradename
Company
Number
Date
Products
TYMLOSRadius HealthN-208743 RX2017-04-28
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
tymlosNew Drug Application2023-09-06
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration
Code
ABALOPARATIDE, TYMLOS, RADIUS
2025-12-19I-907
2024-09-20M-270
Patent Expiration
Patent
Expires
Flag
FDA Information
Abaloparatide, Tymlos, Radius
112558422040-01-10U-3322
116809422040-01-10U-3322
109962082038-04-30DP
117820412038-04-30DPU-2009, U-3543
RE494442031-04-28U-2009, U-3543
78037702031-04-28U-2009
81483332027-11-08DP
87483822027-10-03U-2009, U-3543
ATC Codes
H: Systemic hormonal preparations, excl. sex hormones and insulins
— H05: Calcium homeostasis
— H05A: Parathyroid hormones and analogues
— H05AA: Parathyroid hormones and analogues
— H05AA04: Abaloparatide
HCPCS
No data
Clinical
Clinical Trials
20 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Postmenopausal osteoporosisD015663EFO_0003854—114118
OsteoporosisD010024HP_0000939M81.01141—7
Femoral fracturesD005264—S72———1—1
Replacement arthroplasty kneeD019645—————1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Osteoporotic fracturesD058866————1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Intervertebral disc degenerationD055959HP_0008419——1———1
Spinal fusionD013123———1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myelodysplastic syndromesD009190—D461————1
Myelomonocytic leukemia chronicD015477—C93.11————1
Healthy volunteers/patients———1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAbaloparatide
INNabaloparatide
Description
Abaloparatide (brand name Tymlos) is a parathyroid hormone-related protein (PTHrP) analog drug used to treat osteoporosis. Like the related drug teriparatide, and unlike bisphosphonates, it is an anabolic (i.e., bone growing) agent.
Classification
Protein
Drug classpeptides: parathyroid hormone related peptide
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID247062-33-5
RxCUI—
ChEMBL IDCHEMBL3301581
ChEBI ID—
PubChem CID76943386
DrugBankDB05084
UNII IDAVK0I6HY2U (ChemIDplus, GSRS)
Target
Agency Approved
PTH1R
PTH1R
Organism
Homo sapiens
Gene name
PTH1R
Gene synonyms
PTHR, PTHR1
NCBI Gene ID
Protein name
parathyroid hormone/parathyroid hormone-related peptide receptor
Protein synonyms
Parathyroid hormone 1 receptor, parathyroid hormone receptor 1, parathyroid hormone/parathyroid hormone-related protein receptor, PTH/PTHr receptor, PTH/PTHrP type I receptor, PTH1 receptor, seven transmembrane helix receptor
Uniprot ID
Mouse ortholog
Pth1r (19228)
parathyroid hormone/parathyroid hormone-related peptide receptor (Q80WU8)
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 964 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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9,721 adverse events reported
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