Mobic, Zynrelef(meloxicam)
Mobic, Zynrelef (meloxicam) is a small molecule pharmaceutical. Meloxicam was first approved as Mobic on 2000-04-13. It is used to treat osteoarthritis and rheumatoid arthritis in the USA. It has been approved in Europe to treat postoperative pain. The pharmaceutical is active against prostaglandin G/H synthase 2. In addition, it is known to target prostaglandin G/H synthase 1.
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Commercial
Trade Name
FDA
EMA
Mobic (generic drugs available since 2006-07-19, discontinued: Anjeso, Qmiiz, Vivlodex)
CombinationsZynrelef
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Bupivacaine
+
Meloxicam
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ZYNRELEF KIT | Heron Therapeutics | N-211988 PEND | 2021-05-12 | 4 products, RLD |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| anjeso | New Drug Application | 2020-11-11 |
| meloxicam | ANDA | 2023-06-19 |
| trepoxicam-7.5 | unapproved drug other | 2011-08-01 |
| vivlodex | New Drug Application | 2020-06-24 |
| zynrelef | New Drug Application | 2021-05-21 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| osteoarthritis | EFO_0002506 | D010003 | M15-M19 |
| rheumatoid arthritis | EFO_0000685 | D001172 | M06.9 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
BUPIVACAINE / MELOXICAM, ZYNRELEF KIT, HERON THERAPS INC | |||
| 2024-05-12 | NP | ||
MELOXICAM, ANJESO, BAUDAX | |||
| 2023-02-20 | NP | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Meloxicam, Anjeso, Baudax | |||
| 10881663 | 2039-03-08 | U-3038 | |
| 11458145 | 2039-03-08 | U-3318 | |
| 9974746 | 2030-05-26 | DP | |
| 10709713 | 2030-05-26 | U-2750 | |
| 11253478 | 2030-05-26 | DP | U-3318 |
| 10463673 | 2024-02-24 | DP | U-2750 |
| 10471067 | 2024-02-24 | DP | U-2750 |
| Bupivacaine / Meloxicam, Zynrelef Kit, Heron Theraps Inc | |||
| 9694079 | 2035-04-20 | DP | U-3118 |
| 9801945 | 2035-04-20 | DP | U-3118 |
| 10098957 | 2035-04-20 | U-3118 | |
| 10213510 | 2035-04-20 | DP | U-3118 |
| 10632199 | 2035-04-20 | DP | U-3118 |
| 10898575 | 2035-04-20 | DP | U-3118 |
| 10980886 | 2035-04-20 | DP | |
| 11083730 | 2035-04-20 | DP | U-3118 |
| 11083797 | 2035-04-20 | DP | U-3118 |
| 11413350 | 2035-04-20 | U-3417 | |
| 9592227 | 2034-03-13 | DP | U-3118 |
| 9744163 | 2034-03-13 | DP | |
| 9913909 | 2034-03-13 | U-3118 | |
| 10398686 | 2034-03-13 | DP | |
| 11253504 | 2034-03-13 | U-3118 | |
| Meloxicam, Vivlodex, Iceutica Operations | |||
| 9649318 | 2035-03-31 | DP | |
| 9808468 | 2035-03-31 | U-2160, U-2165 | |
| 9526734 | 2033-03-31 | DP | |
| Meloxicam, Qmiiz Odt, Tersera | |||
| 8545879 | 2030-08-31 | DP | |
ATC Codes
M: Musculo-skeletal system drugs
— M01: Antiinflammatory and antirheumatic products
— M01A: Antiinflammatory and antirheumatic products, non-steroids
— M01AC: Oxicams, antiinflammatory and antirheumatic drugs
— M01AC06: Meloxicam
— M01AC56: Meloxicam, combinations
N: Nervous system drugs
— N01: Anesthetics
— N01B: Local anesthetics
— N01BB: Amide local anesthetics
— N01BB59: Bupivacaine and meloxicam
Clinical
Clinical Trials
103 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 20 | — | — | 1 | — | 21 | ||
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | 1 | 5 | 3 | 1 | 10 |
| Postoperative pain | D010149 | G89.18 | — | 1 | 5 | 2 | 1 | 9 | |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | 1 | 1 | 1 | 1 | 4 |
| Ankylosing spondylitis | D013167 | EFO_0003898 | M45 | — | 1 | 2 | 1 | — | 3 |
| Radiculopathy | D011843 | M54.1 | — | — | — | 1 | 2 | 3 | |
| Pharyngitis | D010612 | R07.0 | — | 1 | — | 1 | — | 2 | |
| Anesthesia | D000758 | — | — | — | 1 | — | 1 | ||
| Biliary atresia | D001656 | EFO_0004217 | Q44.2 | — | — | — | 1 | — | 1 |
| Spinal cord diseases | D013118 | HP_0002196 | G95.9 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | — | 2 | — | 5 | 7 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | — | 3 | — | 1 | 4 |
| Shoulder pain | D020069 | HP_0030834 | M25.51 | — | — | 2 | — | — | 2 |
| Juvenile arthritis | D001171 | EFO_0002609 | M08 | — | — | 2 | — | — | 2 |
| Low back pain | D017116 | HP_0003419 | M54.5 | — | — | 2 | — | — | 2 |
| Dysmenorrhea | D004412 | HP_0100607 | N94.6 | — | 2 | 1 | — | — | 2 |
| Laparoscopy | D010535 | — | — | 1 | — | — | 1 | ||
| Postpartum period | D049590 | — | — | 1 | — | — | 1 | ||
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | — | — | 1 | — | — | 1 |
| Prostatic neoplasms | D011471 | C61 | — | — | 1 | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Intervertebral disc degeneration | D055959 | HP_0008419 | — | — | — | — | 5 | 5 | |
| Inflammation | D007249 | — | — | — | — | 2 | 2 | ||
| Headache | D006261 | HP_0002315 | R51 | — | — | — | — | 1 | 1 |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | — | — | — | — | 1 | 1 |
| Tendinopathy | D052256 | EFO_1001434 | M77.9 | — | — | — | — | 1 | 1 |
| Synovitis | D013585 | EFO_0008997 | M67.5 | — | — | — | — | 1 | 1 |
| Spasm | D013035 | M62.83 | — | — | — | — | 1 | 1 | |
| Gout | D006073 | EFO_0004274 | M10 | — | — | — | — | 1 | 1 |
| Ankle fractures | D064386 | S82.5 | — | — | — | — | 1 | 1 | |
| Bunion | D000071378 | M21.61 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | MELOXICAM |
| INN | meloxicam |
| Description | Meloxicam is a benzothiazine that is piroxicam in which the pyridin-2-yl group is replaced by a 5-methyl-1,3-thiazol-2-yl group. A non-steroidal anti-inflammatory drug and selective inhibitor of COX-2, it is used particularly for the management of rheumatoid arthritis. It has a role as a non-steroidal anti-inflammatory drug, an antirheumatic drug, a cyclooxygenase 2 inhibitor and an analgesic. It is a benzothiazine, a monocarboxylic acid amide and a member of 1,3-thiazoles. |
| Classification | Small molecule |
| Drug class | anti-inflammatory agents (isoxicam type) |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | Cc1cnc(NC(=O)C2=C(O)c3ccccc3S(=O)(=O)N2C)s1 |
Target
Agency Approved
PTGS2
PTGS2
Organism
Homo sapiens
Gene name
PTGS2
Gene synonyms
COX2
NCBI Gene ID
Protein name
prostaglandin G/H synthase 2
Protein synonyms
COX-2, cyclooxygenase 2, cyclooxygenase 2b, Cyclooxygenase-2, PGH synthase 2, PGHS-2, PHS II, Prostaglandin H2 synthase 2, Prostaglandin-endoperoxide synthase 2, prostaglandin-endoperoxide synthase 2 (prostaglandin G/H synthase and cyclooxygenase)
Uniprot ID
Mouse ortholog
Ptgs2 (19225)
prostaglandin G/H synthase 2 (Q543K3)
Alternate
PTGS1
PTGS1
Organism
Homo sapiens
Gene name
PTGS1
Gene synonyms
COX1
NCBI Gene ID
Protein name
prostaglandin G/H synthase 1
Protein synonyms
COX-1, Cyclooxygenase-1, PGH synthase 1, PGHS-1, PHS 1, Prostaglandin H2 synthase 1, Prostaglandin-endoperoxide synthase 1, prostaglandin-endoperoxide synthase 1 (prostaglandin G/H synthase and cyclooxygenase)
Uniprot ID
Mouse ortholog
Ptgs1 (19224)
prostaglandin G/H synthase 1 (P22437)
Variants
Clinical Variant
No data
Financial
Zynrelef - HERON THERAPEUTICS, INC. /DE/
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Trends
PubMed Central
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Additional graphs summarizing 11,879 documents
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Safety
Black-box Warning
Black-box warning for: Anjeso, Meloxicam, Trepoxicam-7.5, Vivlodex, Zynrelef
Adverse Events
Top Adverse Reactions
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854 adverse events reported
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