JPWO2021175857A5 - - Google Patents
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- JPWO2021175857A5 JPWO2021175857A5 JP2022552946A JP2022552946A JPWO2021175857A5 JP WO2021175857 A5 JPWO2021175857 A5 JP WO2021175857A5 JP 2022552946 A JP2022552946 A JP 2022552946A JP 2022552946 A JP2022552946 A JP 2022552946A JP WO2021175857 A5 JPWO2021175857 A5 JP WO2021175857A5
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- 239000008194 pharmaceutical composition Substances 0.000 claims 51
- UUSZLLQJYRSZIS-LXNNNBEUSA-N plitidepsin Chemical compound CN([C@H](CC(C)C)C(=O)N[C@@H]1C(=O)N[C@@H]([C@H](CC(=O)O[C@H](C(=O)[C@H](C)C(=O)N[C@@H](CC(C)C)C(=O)N2CCC[C@H]2C(=O)N(C)[C@@H](CC=2C=CC(OC)=CC=2)C(=O)O[C@@H]1C)C(C)C)O)[C@@H](C)CC)C(=O)[C@@H]1CCCN1C(=O)C(C)=O UUSZLLQJYRSZIS-LXNNNBEUSA-N 0.000 claims 36
- 229950008499 plitidepsin Drugs 0.000 claims 36
- 108010049948 plitidepsin Proteins 0.000 claims 36
- 150000003839 salts Chemical class 0.000 claims 31
- 241000711573 Coronaviridae Species 0.000 claims 24
- 206010061218 Inflammation Diseases 0.000 claims 23
- 230000004054 inflammatory process Effects 0.000 claims 23
- 208000015181 infectious disease Diseases 0.000 claims 18
- 239000003246 corticosteroid Substances 0.000 claims 17
- 238000001802 infusion Methods 0.000 claims 14
- 238000012423 maintenance Methods 0.000 claims 11
- 102000002689 Toll-like receptor Human genes 0.000 claims 10
- 108020000411 Toll-like receptor Proteins 0.000 claims 10
- 230000004913 activation Effects 0.000 claims 10
- 244000052769 pathogen Species 0.000 claims 10
- 230000001717 pathogenic effect Effects 0.000 claims 10
- 208000025721 COVID-19 Diseases 0.000 claims 9
- 229960003957 dexamethasone Drugs 0.000 claims 8
- UREBDLICKHMUKA-CXSFZGCWSA-N dexamethasone Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@@H](C)[C@@](C(=O)CO)(O)[C@@]1(C)C[C@@H]2O UREBDLICKHMUKA-CXSFZGCWSA-N 0.000 claims 8
- 230000001154 acute effect Effects 0.000 claims 7
- 206010052015 cytokine release syndrome Diseases 0.000 claims 7
- 208000024891 symptom Diseases 0.000 claims 7
- 206010035664 Pneumonia Diseases 0.000 claims 6
- 241000700605 Viruses Species 0.000 claims 6
- 230000002085 persistent effect Effects 0.000 claims 6
- 206010038687 Respiratory distress Diseases 0.000 claims 5
- 206010040047 Sepsis Diseases 0.000 claims 5
- 206010050685 Cytokine storm Diseases 0.000 claims 4
- 208000009329 Graft vs Host Disease Diseases 0.000 claims 4
- 208000036142 Viral infection Diseases 0.000 claims 4
- 239000002260 anti-inflammatory agent Substances 0.000 claims 4
- 230000003110 anti-inflammatory effect Effects 0.000 claims 4
- 239000003443 antiviral agent Substances 0.000 claims 4
- 208000024908 graft versus host disease Diseases 0.000 claims 4
- 208000027028 long COVID Diseases 0.000 claims 4
- 230000009385 viral infection Effects 0.000 claims 4
- 229940084971 dexamethasone 6 mg Drugs 0.000 claims 3
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 3
- 208000035475 disorder Diseases 0.000 claims 3
- 239000003814 drug Substances 0.000 claims 3
- 230000007774 longterm Effects 0.000 claims 3
- 208000011580 syndromic disease Diseases 0.000 claims 3
- 241001678559 COVID-19 virus Species 0.000 claims 2
- 241000725619 Dengue virus Species 0.000 claims 2
- 241000710842 Japanese encephalitis virus Species 0.000 claims 2
- 241000710771 Tick-borne encephalitis virus Species 0.000 claims 2
- 241000710886 West Nile virus Species 0.000 claims 2
- 241000710772 Yellow fever virus Species 0.000 claims 2
- 241000907316 Zika virus Species 0.000 claims 2
- 238000004113 cell culture Methods 0.000 claims 2
- 229940110544 diphenhydramine hydrochloride 25 mg Drugs 0.000 claims 2
- 229940079593 drug Drugs 0.000 claims 2
- 230000000116 mitigating effect Effects 0.000 claims 2
- 239000000203 mixture Substances 0.000 claims 2
- 229940048946 ondansetron 8 mg Drugs 0.000 claims 2
- 230000002265 prevention Effects 0.000 claims 2
- VMXUWOKSQNHOCA-LCYFTJDESA-N ranitidine Chemical compound [O-][N+](=O)/C=C(/NC)NCCSCC1=CC=C(CN(C)C)O1 VMXUWOKSQNHOCA-LCYFTJDESA-N 0.000 claims 2
- 229960000620 ranitidine Drugs 0.000 claims 2
- 229940051021 yellow-fever virus Drugs 0.000 claims 2
- FELGMEQIXOGIFQ-CYBMUJFWSA-N (3r)-9-methyl-3-[(2-methylimidazol-1-yl)methyl]-2,3-dihydro-1h-carbazol-4-one Chemical compound CC1=NC=CN1C[C@@H]1C(=O)C(C=2C(=CC=CC=2)N2C)=C2CC1 FELGMEQIXOGIFQ-CYBMUJFWSA-N 0.000 claims 1
- 241000712892 Arenaviridae Species 0.000 claims 1
- 241000894006 Bacteria Species 0.000 claims 1
- 241000714198 Caliciviridae Species 0.000 claims 1
- 241001502567 Chikungunya virus Species 0.000 claims 1
- 241000710777 Classical swine fever virus Species 0.000 claims 1
- 241000709687 Coxsackievirus Species 0.000 claims 1
- 102000004127 Cytokines Human genes 0.000 claims 1
- 108090000695 Cytokines Proteins 0.000 claims 1
- 241000710945 Eastern equine encephalitis virus Species 0.000 claims 1
- 241000709661 Enterovirus Species 0.000 claims 1
- 241001529459 Enterovirus A71 Species 0.000 claims 1
- 241000710781 Flaviviridae Species 0.000 claims 1
- 241000710198 Foot-and-mouth disease virus Species 0.000 claims 1
- 241000711549 Hepacivirus C Species 0.000 claims 1
- 241000700586 Herpesviridae Species 0.000 claims 1
- 241000700588 Human alphaherpesvirus 1 Species 0.000 claims 1
- 241000701074 Human alphaherpesvirus 2 Species 0.000 claims 1
- 241000369733 Lagovirus Species 0.000 claims 1
- 241000036626 Nebovirus Species 0.000 claims 1
- 241001263478 Norovirus Species 0.000 claims 1
- 241000714209 Norwalk virus Species 0.000 claims 1
- 241000712464 Orthomyxoviridae Species 0.000 claims 1
- 241000712910 Pichinde mammarenavirus Species 0.000 claims 1
- 241000709664 Picornaviridae Species 0.000 claims 1
- 206010037660 Pyrexia Diseases 0.000 claims 1
- 241000365416 Recovirus Species 0.000 claims 1
- 241000712907 Retroviridae Species 0.000 claims 1
- 241000713124 Rift Valley fever virus Species 0.000 claims 1
- 241000710799 Rubella virus Species 0.000 claims 1
- 241001135555 Sandfly fever Sicilian virus Species 0.000 claims 1
- 241000369757 Sapovirus Species 0.000 claims 1
- 241000710961 Semliki Forest virus Species 0.000 claims 1
- 241000580858 Simian-Human immunodeficiency virus Species 0.000 claims 1
- 241000710960 Sindbis virus Species 0.000 claims 1
- 241000710924 Togaviridae Species 0.000 claims 1
- 241000710959 Venezuelan equine encephalitis virus Species 0.000 claims 1
- 241000369696 Vesivirus Species 0.000 claims 1
- 241000710951 Western equine encephalitis virus Species 0.000 claims 1
- 210000003403 autonomic nervous system Anatomy 0.000 claims 1
- 239000008280 blood Substances 0.000 claims 1
- 210000004369 blood Anatomy 0.000 claims 1
- 210000000748 cardiovascular system Anatomy 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 229960001334 corticosteroids Drugs 0.000 claims 1
- 229960004833 dexamethasone phosphate Drugs 0.000 claims 1
- VQODGRNSFPNSQE-CXSFZGCWSA-N dexamethasone phosphate Chemical group C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@@H](C)[C@@](C(=O)COP(O)(O)=O)(O)[C@@]1(C)C[C@@H]2O VQODGRNSFPNSQE-CXSFZGCWSA-N 0.000 claims 1
- 241001492478 dsDNA viruses, no RNA stage Species 0.000 claims 1
- 241001493065 dsRNA viruses Species 0.000 claims 1
- 210000005095 gastrointestinal system Anatomy 0.000 claims 1
- 208000005252 hepatitis A Diseases 0.000 claims 1
- 206010022000 influenza Diseases 0.000 claims 1
- 238000002347 injection Methods 0.000 claims 1
- 239000007924 injection Substances 0.000 claims 1
- 210000002540 macrophage Anatomy 0.000 claims 1
- 230000002503 metabolic effect Effects 0.000 claims 1
- 210000002346 musculoskeletal system Anatomy 0.000 claims 1
- 210000000653 nervous system Anatomy 0.000 claims 1
- 229960005343 ondansetron Drugs 0.000 claims 1
- 229940048949 ondansetron 4 mg Drugs 0.000 claims 1
- 230000000770 proinflammatory effect Effects 0.000 claims 1
- 230000000069 prophylactic effect Effects 0.000 claims 1
- 230000007115 recruitment Effects 0.000 claims 1
- 210000005227 renal system Anatomy 0.000 claims 1
- 230000000241 respiratory effect Effects 0.000 claims 1
- 210000002345 respiratory system Anatomy 0.000 claims 1
- 230000028327 secretion Effects 0.000 claims 1
- 230000003612 virological effect Effects 0.000 claims 1
Claims (49)
前記注入が、1時間注入、1.5時間注入、2時間注入、又は3時間注入;好ましくは、1.5時間注入である、
請求項1から29のいずれか一項に記載の医薬組成物。 said plitidepsin or a pharmaceutically acceptable salt or stereoisomer thereof is administered by injection ; optionally,
the infusion is a 1 hour infusion, a 1.5 hour infusion, a 2 hour infusion, or a 3 hour infusion; preferably a 1.5 hour infusion;
30. A pharmaceutical composition according to any one of claims 1 to 29 .
投薬レジメンが、
1日目は2.5mgの負荷用量、その後の日には2mg/日の維持用量;
1日目は2.5mgの負荷用量、その後の日には1.5mg/日の維持用量;
1日目は2.5mgの負荷用量、その後の日には1mg/日の維持用量;
1日目は2.5mgの負荷用量、その後の日には0.5mg/日の維持用量;
1日目は2mgの負荷用量、その後の日には1.5mg/日の維持用量;
1日目は2mgの負荷用量、その後の日には1mg/日の維持用量;
1日目は2mgの負荷用量、その後の日には0.5mg/日の維持用量;
1日目は1.5mgの負荷用量、その後の日には1mg/日の維持用量;
1日目は1.5mgの負荷用量、その後の日には0.5mg/日の維持用量;又は
1日目は1mgの負荷用量、その後の日には0.5mg/日の維持用量である、
請求項1から31のいずれか一項に記載の医薬組成物。 said plitidepsin or a pharmaceutically acceptable salt or stereoisomer thereof is administered using a loading dose and a maintenance dose ; optionally,
The medication regimen is
2.5 mg loading dose on day 1, 2 mg/day maintenance dose on subsequent days;
2.5 mg loading dose on day 1 and 1.5 mg/day maintenance dose on subsequent days;
2.5 mg loading dose on day 1, 1 mg/day maintenance dose on subsequent days;
loading dose of 2.5 mg on day 1 and maintenance dose of 0.5 mg/day on subsequent days;
2 mg loading dose on day 1 and 1.5 mg/day maintenance dose on subsequent days;
2 mg loading dose on day 1, 1 mg/day maintenance dose on subsequent days;
2 mg loading dose on day 1 and maintenance dose of 0.5 mg/day on subsequent days;
Loading dose of 1.5 mg on day 1 and maintenance dose of 1 mg/day on subsequent days;
1.5 mg loading dose on day 1 and maintenance dose of 0.5 mg/day on subsequent days; or
loading dose of 1 mg on day 1 and maintenance dose of 0.5 mg/day on subsequent days ;
32. A pharmaceutical composition according to any one of claims 1 to 31 .
前記コルチコステロイドが、また、その後の日の1又は複数に投与されことができ;好ましくは、前記コルチコステロイドが、前記プリチデプシン又はその薬学的に許容される塩若しくは立体異性体と共に1~3日目に投与され、前記コルチコステロイドが、4~10日目のうちの1又は複数に更に投与され;任意選択で、
前記コルチコステロイドが、前記プリチデプシン又はその薬学的に許容される塩若しくは立体異性体を投与する日に静脈内投与されるが、その後の日に経口投与又はIVにより投与される、
請求項1から32のいずれか一項に記載の医薬組成物。 The plitidepsin or a pharmaceutically acceptable salt or stereoisomer thereof is administered in combination with a corticosteroid , and the corticosteroid is administered in combination with the administration of the plitidepsin or a pharmaceutically acceptable salt or stereoisomer thereof. administered on the same day ; optionally,
Said corticosteroid may also be administered on one or more subsequent days; preferably said corticosteroid is administered in combination with said plitidepsin or a pharmaceutically acceptable salt or stereoisomer thereof for 1 to 3 days. and the corticosteroid is further administered on one or more of days 4 to 10; optionally,
the corticosteroid is administered intravenously on the day of administering the plitidepsin or a pharmaceutically acceptable salt or stereoisomer thereof, but is administered orally or by IV on a subsequent day;
33. A pharmaceutical composition according to any one of claims 1 to 32 .
前記デキサメタゾンが、その後の日、好ましくは4、5、6、7、8、9、及び10日目のうちの1又は複数に6mg/日の用量で経口投与されか、又はIVで投与される、
請求項33に記載の医薬組成物。 said corticosteroid is dexamethasone, preferably dexamethasone is administered IV at a dose of 6.6 mg/day on the day that said plitidepsin or a pharmaceutically acceptable salt or stereoisomer thereof is administered; optionally ,
said dexamethasone is administered orally or IV at a dose of 6 mg/day on one or more of subsequent days, preferably days 4, 5, 6, 7, 8, 9, and 10. ,
34. A pharmaceutical composition according to claim 33 .
前記プリチデプシン又はその薬学的に許容される塩若しくは立体異性体が、1日目~3日目にデキサメタゾン6.6mg/日静脈内IVと組み合わせて、2.0mg/日で静脈内(IV)投与され、続いて、4日目から最長10日目まで(患者の臨床状態及び進展に応じた医師の判断に従って)、デキサメタゾン6mg/日が経口投与(PO)/IVされるか;又は
前記プリチデプシン又はその薬学的に許容される塩若しくは立体異性体が、1日目~3日目にデキサメタゾン6.6mg/日静脈内IVと組み合わせて、2.5mg/日で静脈内(IV)投与され、続いて、4日目から最長10日目まで(患者の臨床状態及び進展に応じた医師の判断に従って)、デキサメタゾン6mg/日が経口投与(PO)/IVされる、請求項1から34のいずれか一項に記載の医薬組成物。 said plitidepsin or a pharmaceutically acceptable salt or stereoisomer thereof is administered intravenously (IV) at 1.5 mg/day in combination with dexamethasone 6.6 mg/day IV on days 1 to 3; followed by dexamethasone 6 mg/ day orally (PO)/IV from day 4 until up to day 10 (as determined by the physician depending on the patient's clinical status and evolution); or
said plitidepsin or a pharmaceutically acceptable salt or stereoisomer thereof is administered intravenously (IV) at 2.0 mg/day in combination with dexamethasone 6.6 mg/day IV on days 1 to 3; followed by dexamethasone 6 mg/ day orally (PO)/IV from day 4 until up to day 10 (as determined by the physician depending on the patient's clinical status and evolution); or
said plitidepsin or a pharmaceutically acceptable salt or stereoisomer thereof is administered intravenously (IV) at 2.5 mg/day in combination with dexamethasone 6.6 mg/day IV on days 1 to 3; Any of claims 1 to 34 , wherein dexamethasone 6 mg/day is subsequently administered orally (PO)/IV from day 4 up to day 10 (according to the physician's judgment according to the patient's clinical condition and evolution). The pharmaceutical composition according to item 1.
オンダンセトロン8mg IV(又は同等物);
ジフェンヒドラミン塩酸塩25mg IV(又は同等物);及び
ラニチジン50mg IV(又は同等物)
を受ける、請求項1から36のいずれか一項に記載の医薬組成物。 Before said patient begins treatment with said plitidepsin or a pharmaceutically acceptable salt or stereoisomer thereof , preferably 20 to 30 minutes, the following drugs:
Ondansetron 8mg IV (or equivalent);
diphenhydramine hydrochloride 25 mg IV (or equivalent); and ranitidine 50 mg IV (or equivalent)
37. A pharmaceutical composition according to any one of claims 1 to 36 , wherein the pharmaceutical composition receives:
前記単回用量が、1~10mg、4~10mg、4.5~10mg;4mg、4.5mg、5mg、5.5mg、6mg、6.5mg、7mg、7.5mg、8mg、8.5mg、9mg、9.5mg又は10mg;より好ましくは4.5mg、5mg、6mg、7.5mg、8mg、9mg又は10mg;より好ましくは、5~9mg、6.5~8.5mg、7~8mg又は最も好ましくは、7.5mgである、
請求項1から30のいずれか一項に記載の医薬組成物。 said plitidepsin or a pharmaceutically acceptable salt or stereoisomer thereof is administered as a single dose (on day 1) ; optionally,
Said single dose is 1-10mg, 4-10mg, 4.5-10mg; 4mg, 4.5mg, 5mg, 5.5mg, 6mg, 6.5mg, 7mg, 7.5mg, 8mg, 8.5mg, 9mg, 9.5mg or 10mg; More preferably 4.5 mg, 5 mg, 6 mg, 7.5 mg, 8 mg, 9 mg or 10 mg; more preferably 5-9 mg, 6.5-8.5 mg, 7-8 mg or most preferably 7.5 mg.
31. A pharmaceutical composition according to any one of claims 1 to 30 .
コルチコステロイドが、請求項33から36のいずれか一項に定義のレジメンに従って投与され;及び/或いは
前記プリチデプシン又はその薬学的に許容される塩若しくは立体異性体の投与の20~30分前に、以下の予防薬:
オンダンセトロン8mg IV(又は同等物)、特に15分間の緩徐な注入による;
ジフェンヒドラミン塩酸塩25mg IV(又は同等物);
ラニチジン50mg IV(又は同等物)
が投与され;及び/或いは
前記プリチデプシン又はその薬学的に許容される塩若しくは立体異性体の投与後、オンダンセトロン4mgが12時間ごとに3日間経口的に与えられる、
請求項39に記載の医薬組成物。 said plitidepsin or a pharmaceutically acceptable salt or stereoisomer thereof is administered as a 1.5 hour infusion ; and/or
the corticosteroid is administered according to the regimen defined in any one of claims 33 to 36; and/or
20 to 30 minutes before administration of said plitidepsin or its pharmaceutically acceptable salt or stereoisomer, the following prophylactic agents:
Ondansetron 8 mg IV (or equivalent), especially by slow infusion over 15 minutes;
Diphenhydramine hydrochloride 25mg IV (or equivalent);
Ranitidine 50mg IV (or equivalent)
is administered; and/or
After administration of said plitidepsin or a pharmaceutically acceptable salt or stereoisomer thereof, ondansetron 4 mg is given orally every 12 hours for 3 days ;
40. A pharmaceutical composition according to claim 39 .
Applications Claiming Priority (15)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP20382152.5 | 2020-03-02 | ||
EP20382152 | 2020-03-02 | ||
EP20382192.1 | 2020-03-13 | ||
EP20382192 | 2020-03-13 | ||
EP20382266.3 | 2020-04-02 | ||
EP20382266 | 2020-04-02 | ||
EP20382339 | 2020-04-27 | ||
EP20382339.8 | 2020-04-27 | ||
EP20382816.5 | 2020-09-16 | ||
EP20382816 | 2020-09-16 | ||
EP20382815.7 | 2020-09-16 | ||
EP20382815 | 2020-09-16 | ||
EP21382059 | 2021-01-25 | ||
EP21382059.0 | 2021-01-25 | ||
PCT/EP2021/055187 WO2021175857A1 (en) | 2020-03-02 | 2021-03-02 | Compounds for use in inflammatory conditions |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2023517536A JP2023517536A (en) | 2023-04-26 |
JPWO2021175857A5 true JPWO2021175857A5 (en) | 2024-03-12 |
Family
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JP2022552946A Pending JP2023517536A (en) | 2020-03-02 | 2021-03-02 | Compounds for use in inflammatory conditions |
JP2022552937A Pending JP2023517535A (en) | 2020-03-02 | 2021-03-02 | Compounds for use in viral infections |
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JP2022552937A Pending JP2023517535A (en) | 2020-03-02 | 2021-03-02 | Compounds for use in viral infections |
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Country | Link |
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US (2) | US20230159594A1 (en) |
EP (2) | EP4114433A2 (en) |
JP (2) | JP2023517536A (en) |
KR (2) | KR20220150350A (en) |
CN (2) | CN115461067A (en) |
AU (2) | AU2021231197A1 (en) |
BR (2) | BR112022016675A2 (en) |
CA (2) | CA3169544A1 (en) |
CL (2) | CL2022002395A1 (en) |
CO (2) | CO2022014093A2 (en) |
IL (2) | IL296069A (en) |
MX (2) | MX2022010921A (en) |
PE (2) | PE20230606A1 (en) |
TW (2) | TW202144381A (en) |
UY (2) | UY39109A (en) |
WO (2) | WO2021175857A1 (en) |
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WO2024165764A1 (en) * | 2023-02-10 | 2024-08-15 | Pharma Mar, S.A. | Plitidepsin for use in the treatment of non-integrated dna viral infections |
CN117285611B (en) * | 2023-11-24 | 2024-02-09 | 中国海洋大学 | Anti-inflammatory oligopeptide from sea squirt and application of anti-inflammatory oligopeptide in preparation of medicines |
Family Cites Families (7)
Publication number | Priority date | Publication date | Assignee | Title |
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GB8922026D0 (en) * | 1989-09-29 | 1989-11-15 | Pharma Mar Sa | Novel anti-viral and cytotoxic agent |
US6156724A (en) * | 1996-06-07 | 2000-12-05 | Rinehart; Kenneth L. | Uses of didemnins as immunomodulating agents |
GB9803448D0 (en) | 1998-02-18 | 1998-04-15 | Pharma Mar Sa | Pharmaceutical formulation |
WO2001076616A1 (en) | 2000-04-07 | 2001-10-18 | The Trustees Of The University Of Pennsylvania | Tamandarin and didemnin analogs and methods of making and using them |
UA76718C2 (en) | 2000-06-30 | 2006-09-15 | Фарма Мар, С.А. | Anticancer aplidine derivatives |
US8030279B2 (en) | 2003-03-21 | 2011-10-04 | The Trustees Of The University Of Pennsylvania | Tamandarin analogs and fragments thereof and methods of making and using |
WO2011020913A2 (en) | 2009-08-21 | 2011-02-24 | Pharma Mar, S.A. | Cyclodepsipeptide antiviral compounds |
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2021
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