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{{Short description|Chemical compound}}
{{Drugbox
{{Use dmy dates|date=December 2023}}
| IUPAC_name = (3''R'')-3-cyclopentyl-3-pyrimidin-4-yl)pyrazol-1-yl]propanenitrile
{{cs1 config |name-list-style=vanc |display-authors=6}}
| image = Ruxolitinib skeletal.svg
{{Infobox drug
| width = 120px
| Verifiedfields = changed
| Watchedfields = changed
| verifiedrevid = 461425696
| image = Filgotinib.svg
| width =
| alt =
| caption =


<!--Clinical data--> <!-- Clinical data -->
| tradename = | tradename = Jyseleca
| Drugs.com =
| MedlinePlus =
| DailyMedID = <!-- DailyMed may use generic or brand name (generic name preferred) -->
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X --> | pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
| pregnancy_AU_comment =
| pregnancy_US = <!-- A / B / C / D / X -->
| pregnancy_category = | pregnancy_category=
| routes_of_administration = ]
| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled-->
| class = ]
| legal_CA = <!-- Schedule I, II, III, IV, V, VI, VII, VIII -->
| ATC_prefix = L04
| legal_UK = <!-- GSL, P, POM, CD, or Class A, B, C -->
| ATC_suffix = AF04
| ATC_supplemental =

<!-- Legal status -->
| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled -->
| legal_AU_comment =
| legal_BR = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F -->
| legal_BR_comment =
| legal_CA = <!-- OTC, Rx-only, Schedule I, II, III, IV, V, VI, VII, VIII -->
| legal_CA_comment =
| legal_DE = <!-- Anlage I, II, III or Unscheduled -->
| legal_DE_comment =
| legal_NZ = <!-- Class A, B, C -->
| legal_NZ_comment =
| legal_UK = POM
| legal_UK_comment = <ref>{{cite web | title=Jyseleca 100 mg film-coated tablets - Summary of Product Characteristics (SmPC) | website=(emc) | date=1 October 2020 | url=https://www.medicines.org.uk/emc/product/11809/smpc | access-date=4 October 2020}}</ref>
| legal_US = <!-- OTC / Rx-only / Schedule I, II, III, IV, V --> | legal_US = <!-- OTC / Rx-only / Schedule I, II, III, IV, V -->
| legal_US_comment =
| legal_status = Investigational
| legal_EU = Rx-only
| routes_of_administration = Oral, topical
| legal_EU_comment = <ref name="Jyseleca EPAR">{{cite web | title=Jyseleca EPAR | website=] (EMA) | date=26 May 2020 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/jyseleca | access-date=4 October 2020}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref><ref>{{cite web | title=Jyseleca Product information | website=Union Register of medicinal products | url=https://ec.europa.eu/health/documents/community-register/html/h1480.htm | access-date=3 March 2023}}</ref>
| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV -->
| legal_UN_comment =
| legal_status = Rx-only


<!--Pharmacokinetic data--> <!-- Pharmacokinetic data -->
| bioavailability = >95%<ref>{{pmid|20699411}}</ref> | bioavailability =
| protein_bound = | protein_bound =
| metabolism = <50% (], ]) | metabolism =
| metabolites =
| elimination_half-life =
| onset =
| excretion = 74% urine, 22% faeces
| elimination_half-life = 6 hours<ref name = Namour>{{cite journal | vauthors = Namour F, Diderichsen PM, Cox E, Vayssière B, Van der Aa A, Tasset C, Van't Klooster G | title = Pharmacokinetics and Pharmacokinetic/Pharmacodynamic Modeling of Filgotinib (GLPG0634), a Selective JAK1 Inhibitor, in Support of Phase IIB Dose Selection | journal = Clinical Pharmacokinetics | volume = 54 | issue = 8 | pages = 859–74 | date = August 2015 | pmid = 25681059 | pmc = 4513223 | doi = 10.1007/s40262-015-0240-z }}</ref>
| duration_of_action =
| excretion =


<!--Identifiers--> <!-- Identifiers -->
| index2_label = as salt
| ChemSpiderID = 25027389
| CAS_number_Ref = {{cascite|correct|??}}
| InChI = 1/C17H18N6/c18-7-5-15(12-3-1-2-4-12)23-10-13(9-22-23)16-14-6-8-19-17(14)21-11-20-16/h6,8-12,15H,1-5H2,(H,19,20,21)/t15-/m1/s1
| CAS_number = 1206161-97-8
| InChIKey = HFNKQEVNSGCOJV-OAHLLOKOBE
| CAS_supplemental =
| CAS_number = 941678-49-5
| ATC_prefix = none | PubChem = 49831257
| ATC_suffix = | IUPHAR_ligand = 7913
| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| ATC_supplemental =
| PubChem = | DrugBank = DB14845
| ChemSpiderID_Ref = {{chemspidercite|correct|chemspider}}
| DrugBank =
| ChemSpiderID = 28189566
| UNII_Ref = {{fdacite|correct|FDA}} | UNII_Ref = {{fdacite|correct|FDA}}
| UNII = 82S8X8XX8H | UNII = 3XVL385Q0M
| KEGG_Ref = {{keggcite|correct|kegg}}
| KEGG =
| KEGG = D10871
| synonyms = INCB018424, INC424
| KEGG2_Ref = {{keggcite|correct|kegg}}
| KEGG2 = D11106
| ChEBI_Ref =
| ChEBI =
| ChEMBL_Ref = {{ebicite|changed|EBI}}
| ChEMBL = 3301607
| NIAID_ChemDB =
| PDB_ligand = 2HB
| synonyms = GLPG0634, GS-6034<ref>{{cite web | title=Pipeline | publisher=] | date=27 July 2020 | url=https://www.gilead.com/science-and-medicine/pipeline | access-date=27 July 2020}}</ref>


<!--Chemical data--> <!-- Chemical and physical data -->
| IUPAC_name = ''N''-phenyl]-triazolopyridin-2-yl]cyclopropanecarboxamide
| chemical_formula =
| C=17 | H=18 | N=6 | C=21 | H=23 | N=5 | O=3 | S=1
| SMILES = O=C(Nc1nc2cccc(-c3ccc(CN4CCS(=O)(=O)CC4)cc3)n2n1)C1CC1
| molecular_weight = 306.37 g/mol
| StdInChI_Ref = {{stdinchicite|correct|chemspider}}
| smiles = C1CCC(C1)C(CC#N)N2C=C(C=N2)C3=C4C=CNC4=NC=N3
| StdInChI = 1S/C17H18N6/c18-7-5-15(12-3-1-2-4-12)23-10-13(9-22-23)16-14-6-8-19-17(14)21-11-20-16/h6,8-12,15H,1-5H2,(H,19,20,21)/t15-/m1/s1 | StdInChI = 1S/C21H23N5O3S/c27-20(17-8-9-17)23-21-22-19-3-1-2-18(26(19)24-21)16-6-4-15(5-7-16)14-25-10-12-30(28,29)13-11-25/h1-7,17H,8-14H2,(H,23,24,27)
| StdInChI_comment =
| StdInChIKey = HFNKQEVNSGCOJV-OAHLLOKOSA-N
| StdInChIKey_Ref = {{stdinchicite|correct|chemspider}}
| StdInChIKey = RIJLVEAXPNLDTC-UHFFFAOYSA-N
| density =
| density_notes =
| melting_point =
| melting_high =
| melting_notes =
| boiling_point =
| boiling_notes =
| solubility =
| sol_units =
| specific_rotation =
}} }}
'''Ruxolitinib''' is a ] being investigated for the treatment of ]s, ], and various types of ]. It is a ] with selectivity for subtypes ] and ] of this enzyme.<ref>{{pmid|20506062}}</ref><ref>{{pmid|21245760}}</ref>


'''Filgotinib''', sold under the brand name '''Jyseleca''', is a medication used for the treatment of ] (RA).<ref name="Jyseleca EPAR" /> It was developed by the ]-] biotech company ].<ref name="Gilead PR 20200925">{{cite press release | title=European Commission Grants Marketing Authorization for Jyseleca (Filgotinib) for the Treatment of Adults With Moderate to Severe Active Rheumatoid Arthritis | publisher=Gilead Sciences | via=Business Wire | date=25 September 2020 | url=https://www.businesswire.com/news/home/20200925005444/en/ | access-date=4 October 2020}}</ref>
Results from Phase II ]s suggest that the drug can substantially improve symptoms and reduce ] size in ] patients, but it has not been shown to produce ].<ref>{{pmid|21079613}}</ref> {{as of|2011|2}}, it is undergoing Phase III trials studying myelofibrosis<ref>{{ClinicalTrialsGov|NCT00952289|COntrolled MyeloFibrosis Study With ORal JAK Inhibitor Treatment: The COMFORT-I Trial}}</ref> and ].<ref>{{ClinicalTrialsGov|NCT01243944|Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 (INCB018424) Tablets Versus Best Available Care: The RESPONSE Trial}}</ref>


The most common side effects include nausea (feeling sick), upper respiratory tract infection (nose and throat infection), urinary tract infection and dizziness.<ref name="Jyseleca EPAR" />
In June 2011, it was announced that both phase III trials of ruxolitinib in the treatment of myelofibrosis (COMFORT-I and -II) met their primary endpoints of a significant increase in number of patients experiencing at least 35% reduction of spleen volume.<ref>ASCO Annual Meeting 2011: </ref>


Filgotinib was approved for medical use in both the European Union and Japan in September 2020.<ref name="Jyseleca EPAR" /><ref name="Gilead PR 20200925" /><ref name="Gilead PR 20200924">{{cite web | title=Jyseleca (Filgotinib) Approved in Japan for Rheumatoid Arthritis | publisher=Gilead Sciences | via=Business Wire | date=25 September 2020 | url=https://www.businesswire.com/news/home/20200924005942/en/ | access-date=4 October 2020}}</ref>
In November 2011, Ruxolitinib was approved by the U.S. Food and Drug Administration for the treatment of intermediate or high-risk myelofibrosis based on results of the COMFORT-I and COMFORT-II Trials.


==References== == Medical uses ==
Filgotinib is ] for the treatment of moderate to severe active rheumatoid arthritis in adults who have responded inadequately to, or who are intolerant to one or more disease‑modifying anti‑rheumatic drugs (DMARDs).<ref name="Jyseleca EPAR" /> Filgotinib may be used as monotherapy or in combination with ] (MTX).<ref name="Jyseleca EPAR" />
{{reflist}}


==Mechanism of action==
]
Filgotinib is a ] with selectivity for subtype ] of this enzyme. It is considered a promising agent as it inhibits JAK1 selectively, similar to already marketed ].{{medcn|date=October 2020}} Less selective JAK inhibitors (e.g. ] and ]) are already being marketed.{{medcn|date=October 2020}} They show long-term efficacy in the treatment of various inflammatory diseases.{{medcn|date=October 2020}} However, their lack of selectivity leads to dose-limiting side effects.<ref name = Namour /> It is thought that inhibition of all JAK isoenzymes is beneficial in rheumatoid arthritis.{{medcn|date=October 2020}} However, pan-JAK inhibition might also lead to unwanted side effects that might not outweigh its benefits.{{medcn|date=October 2020}} This is the rationale for the development of newer and more selective inhibitors like filgotinib.{{medcn|date=July 2020}}


The signal transmission of large numbers of ] ] is dependent on JAK1.{{medcn|date=October 2020}} Inhibition of JAK2 may also contribute to the efficacy against rheumatoid arthritis.{{medcn|date=October 2020}} Nonetheless it is thought that JAK2 inhibition might lead to ] and ] by interference with ] and ] and ].{{medcn|date=October 2020}} Therefore, one might prefer to choose a more selective JAK1 inhibitor as a primary therapeutic option.{{medcn|date=October 2020}} Filgotinib exerts a 30-fold selectivity for JAK1 compared to JAK2.<ref name = Rompaey>{{cite journal | vauthors = Van Rompaey L, Galien R, van der Aar EM, Clement-Lacroix P, Nelles L, Smets B, Lepescheux L, Christophe T, Conrath K, Vandeghinste N, Vayssiere B, De Vos S, Fletcher S, Brys R, van 't Klooster G, Feyen JH, Menet C | title = Preclinical characterization of GLPG0634, a selective inhibitor of JAK1, for the treatment of inflammatory diseases | journal = Journal of Immunology | volume = 191 | issue = 7 | pages = 3568–77 | date = October 2013 | pmid = 24006460 | doi = 10.4049/jimmunol.1201348 | doi-access = free }}</ref> It is however still to be seen to what extent JAK2 inhibition should be avoided.{{medcn|date=July 2020}}


== History ==
{{antineoplastic-drug-stub}}
* June 2011: results of first Phase II trial{{cn|date=April 2022}}
* November 2014: initiation of DARWIN 1 and 2 trials{{cn|date=April 2022}}
* July 2015: DARWIN 1 results released{{cn|date=April 2022}}
* August 2015: DARWIN 2 trial results released{{cn|date=April 2022}}
* September 2015: AbbVie opted out of collaboration with Galapagos<ref>{{cite press release|url=https://news.abbvie.com/news/abbvie-to-advance-once-daily-abt-494-to-phase-3-in-rheumatoid-arthritis-by-year-end.htm|title=AbbVie to Advance Once-Daily ABT-494 to Phase 3 in Rheumatoid Arthritis by Year-End|website=AbbVie|access-date=9 January 2018|archive-date=8 January 2018|archive-url=https://web.archive.org/web/20180108175045/https://news.abbvie.com/news/abbvie-to-advance-once-daily-abt-494-to-phase-3-in-rheumatoid-arthritis-by-year-end.htm|url-status=dead}}</ref>
* December 2015: Galapagos signed partnership with Gilead to co-develop & co-commercialize Filgotinib for various diseases
* December 2019: Gilead submitted a ] (NDA) with a ] voucher to the U.S. ] (FDA) for filgotinib.<ref>{{cite press release | title=Gilead Submits Filgotinib New Drug Application to U.S. Food and Drug Administration Under Priority Review for Rheumatoid Arthritis Treatment | website=Gilead Sciences, Inc. | date=19 December 2019 | url=https://www.gilead.com/news-and-press/press-room/press-releases/2019/12/gilead-submits-filgotinib-new-drug-application-to-us-food-and-drug-administration-under-priority-review-for-rheumatoid-arthritis-treatment | access-date=27 July 2020}}</ref>
* On 23 July 2020, the ] (CHMP) of the ] (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Jyseleca, intended for the treatment of rheumatoid arthritis.<ref name="Jyseleca: Pending EC decision">{{cite web | title=Jyseleca: Pending EC decision | website=] (EMA) | date=23 July 2020 | url=https://www.ema.europa.eu/en/medicines/human/summaries-opinion/jyseleca | access-date=27 July 2020 | archive-date=27 July 2020 | archive-url=https://web.archive.org/web/20200727102811/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/jyseleca | url-status=dead }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> The applicant for this medicinal product is Gilead Sciences Ireland UC.<ref name="Jyseleca: Pending EC decision" /><ref>{{cite press release | url=https://ml-eu.globenewswire.com/Resource/Download/9f1a9589-35fb-499e-b16f-b9b7d59bd953 | title=Gilead and Galapagos Announce Positive European CHMP Opinion for Jyseleca (Filgotinib) for the Treatment of Adults With Moderate to Severe Rheumatoid Arthritis | date=24 July 2020 | access-date=27 July 2020}}</ref><ref>{{cite press release | title=Gilead and Galapagos Announce Positive European CHMP Opinion for Jyseleca (Filgotinib) for the Treatment of Adults With Moderate to Severe Rheumatoid Arthritis | website=Gilead Sciences, Inc. | date=24 June 2020 | url=https://www.gilead.com/news-and-press/press-room/press-releases/2020/7/gilead-and-galapagos-announce-positive-european-chmp-opinion-for-jyseleca-filgotinib-for-the-treatment-of-adults-with-moderate-to-severe-rheumatoid | access-date=27 July 2020}}</ref>
* 19 August 2020: FDA rejects Gilead’s filing for approval of filgotinib over toxicity concerns<ref>{{cite web|url=https://www.fiercebiotech.com/biotech/fda-rejects-gilead-s-would-be-blockbuster-filgotinib-over-toxicity-concerns|title=FDA rejects Gilead's would-be blockbuster filgotinib over toxicity concerns|date=19 August 2020}}</ref>
* September 2020: Filgotinib was approved for medical use in both the European Union and Japan.<ref name="Jyseleca EPAR" /><ref name="Gilead PR 20200925" /><ref name="Gilead PR 20200924" />

== Research ==
===Clinical trials===
The efficacy of filgotinib is being studied in a ] (DARWIN trial 1, 2) with involvement of 886 rheumatoid arthritis patients and 180 Crohn's disease patients.{{cn|date=July 2020}}

====Phase I study====
It was shown in Phase I studies that the ] of filgotinib metabolism is independent of hepatic ] enzymatic degradation. The drug metabolism is however mediated by ]s. There is no interference reported with the metabolism of ] nor with any of the investigated transport proteins.<ref>{{cite conference |url=http://acrabstracts.org/abstracts/phase-1-and-phase-2-data-confirm-that-glpg0634-a-selective-jak1-inhibitor-has-a-low-potential-for-drug-drug-interactions/ |title=Phase 1 and Phase 2 Data Confirm That GLPG0634, a Selective JAK1 Inhibitor, Has a Low Potential for Drug-Drug Interactions | vauthors = Florence N, Julie D, Van der Aa A, Tasset C, van't Klooster G |date=2014 |publisher=American College of Rheumatology |book-title=Meeting Abstracts |conference=2014 ACR/ARHP Annual Meeting |id=1481}}</ref>

====Phase II study: Proof of concept (2011)====
In November 2011 Galapagos released the results of their Phase II study (identification: NCT01384422, Eudract: 2010-022953-40) in which 36 rheumatoid arthritis patients were treated who showed a suboptimal clinical response to ] treatment.<ref name=NCT01384422>{{ClinicalTrialsGov|NCT01384422|Safety and Preliminary Efficacy of GLPG0634 in Methotrexate-refractory Active Rheumatoid Arthritis}}</ref>{{Full citation needed|date=July 2020}} Three groups of twelve patients were treated either with 200&nbsp;mg filgotinib in a single dose, 200&nbsp;mg divided in two doses or placebo. The primary end-point was the ], which monitors improvements in the symptomatology of the patient. After the scheduled 4 weeks of treatment, 83% of the respondents showed an improved ACR20-score. Half of the treated patients showed a complete (or near complete) remission of the disease. There were no reports of ] nor changes in lipidemia. The company stated in their press release that filgotinib is the first selective JAK1 inhibitor that shows clinical efficacy. As a result of this study, the company stated that "GLPG0634 shows one of the highest initial response rates ever reported for rheumatoid arthritis treatments".<ref>{{cite press release |title=Galapagos' GLPG0634 shows excellent efficacy and safety in rheumatoid arthritis Phase II study |url=http://www.glpg.com/files/5513/3941/7815/2011_31.pdf |access-date=26 February 2015 }}{{Dead link|date=April 2024 |bot=InternetArchiveBot |fix-attempted=yes }}</ref>

====DARWIN 1 trial====
The DARWIN 1 trial was a 24-week ] ] trial with 599 rheumatoid arthritis patients enrolled. All participants had moderate to severe rheumatoid arthritis and showed an insufficient response to standard ] treatment. The trial compared three dosages of filgotinib as a once or twice per day regimen.<ref name=Darwin-1>{{ClinicalTrialsGov|NCT01888874|Dose-finding Study of GLPG0634 as add-on to Methotrexate in Active Rheumatoid Arthritis Patients (DARWIN1)}}</ref>{{Full citation needed|date=July 2020}} During the trial all participants remained on their methotrexate treatment. The trial completed in Feb 2015 and the results were released in July 2015.<ref>{{cite press release |title=Galapagos reports that the last patient in DARWIN 1 has completed 12 weeks of treatment |url=http://www.glpg.com/files/1914/2467/2531/LPLV_Darwin_1__FINAL.pdf |access-date=26 February 2015 |archive-date=26 February 2015 |archive-url=https://web.archive.org/web/20150226192947/http://www.glpg.com/files/1914/2467/2531/LPLV_Darwin_1__FINAL.pdf |url-status=dead }}</ref><ref name=":0">{{cite press release|url=http://www.globenewswire.com/news-release/2015/07/29/756118/10143770/en/Galapagos-selective-JAK1-inhibitor-filgotinib-meets-key-efficacy-endpoints-shows-ACR70-responses-up-to-39-and-maintains-safety-profile-after-24-weeks-of-treatment-in-DARWIN-1-Phase.html|title=Galapagos' selective JAK1 inhibitor filgotinib meets key efficacy endpoints, shows ACR70 responses up to 39%, and maintains safety profile after 24 weeks of treatment in DARWIN 1 Phase 2B study| publisher = Galapagos NV |date=29 July 2015|via=GlobeNewswire }}</ref> Galapagos announced that the drug met key efficacy endpoints, showed ACR70 responses up to 39%, and maintained its safety profile.<ref name=":0" /><ref>{{cite journal | vauthors = Westhovens R, Taylor PC, Alten R, Pavlova D, Enríquez-Sosa F, Mazur M, Greenwald M, Van der Aa A, Vanhoutte F, Tasset C, Harrison P | title = Filgotinib (GLPG0634/GS-6034), an oral JAK1 selective inhibitor, is effective in combination with methotrexate (MTX) in patients with active rheumatoid arthritis and insufficient response to MTX: results from a randomised, dose-finding study (DARWIN 1) | journal = Annals of the Rheumatic Diseases | volume = 76 | issue = 6 | pages = 998–1008 | date = June 2017 | pmid = 27993829 | doi = 10.1136/annrheumdis-2016-210104 | doi-access = free }}</ref>

====DARWIN 2 trial====
The DARWIN 2 trial was a double blind placebo-controlled trial with 280 rheumatoid arthritis patients enrolled who show an insufficient response to standard methotrexate treatment. In contrast to the previous DARWIN 1 trial, methotrexate was discontinued. Therefore, this trial investigates filgotinib as a second-line monotherapy.<ref>{{cite press release |url=http://www.euroinvestor.com/news/2014/11/12/galapagos-completes-recruitment-for-darwin-1-study-with-glpg0634-filgotinib-in-ra/13036399 |title=Galapagos completes recruitment for Darwin 1 study with GLPG0634 (filgotinib) in RA |access-date=26 February 2015 |publisher=Galapagos NV |via=GlobeNewswire |archive-date=26 February 2015 |archive-url=https://web.archive.org/web/20150226201828/http://www.euroinvestor.com/news/2014/11/12/galapagos-completes-recruitment-for-darwin-1-study-with-glpg0634-filgotinib-in-ra/13036399 |url-status=dead }}</ref> The recruitment of DARWIN trial 2b ended in November 2014.<ref>{{cite press release |url=https://finance.yahoo.com/news/galapagos-completes-recruitment-darwin-2-063202270.html |title=Galapagos completes recruitment for Darwin 2 monotherapy study with GLPG0634 (filgotinib) in RA |date=24 November 2014 |access-date=26 February 2015 |publisher=Galapagos NV |via=GlobeNewswire }}</ref> In August 2015, Galapagos announced that the study confirmed previous results.<ref>{{cite press release |url=http://www.globenewswire.com/news-release/2015/08/10/759473/10145519/en/DARWIN-2-24-week-monotherapy-data-in-RA-confirm-previous-results-and-support-best-in-class-potential-for-filgotinib.html|title=DARWIN 2 24-week monotherapy data in RA confirm previous results and support best-in-class potential for filgotinib | publisher = Galapagos NV | date=10 August 2015|via=GlobeNewswire }}</ref>

====DARWIN 3 trial====
Patients who completed DARWIN 1 and 2 were eligible for DARWIN 3. In November 2017, the company announced consistent safety findings and durable activity at week 84 in the trial.<ref>{{cite press release|url=http://www.globenewswire.com/news-release/2017/11/05/1174754/0/en/Consistent-safety-findings-and-durable-activity-with-filgotinib-treatment-of-rheumatoid-arthritis-patients-up-to-week-84-in-DARWIN-3-study.html|title=Consistent safety findings and durable activity with filgotinib treatment of rheumatoid arthritis patients up to week 84 in DARWIN 3 study | publisher = Galapagos NV | date=5 November 2017|via=GlobeNewswire }}</ref> The estimated study completion timeframe is May 2019.<ref>{{ClinicalTrialsGov|NCT02065700|Long-term Follow-up Study of GLPG0634 in Active Rheumatoid Arthritis Patients}}</ref>{{Full citation needed|date=July 2020}}

==== FINCH Phase III trials ====
FINCH 1 looks at patients where first-line treatment with ] (MTX) is not working. It compares filgotinib versus ]/Humira versus a placebo.<ref>{{cite web|url=http://reports.glpg.com/annual-report-2016/en/r-d/rheumatoid-arthritis/filgotinib-program-in-ra.html|title=Filgotinib program in RA - Galapagos Annual Report 2016|website=Galapagos|access-date=8 January 2018}}</ref> FINCH 2 looks at patients where a biologic is not working. FINCH 3 looks at filgotinib as a first-line treatment unlike previous studies that investigated the drug as a second-line treatment.

FINCH 2 trial revealed patients with active rheumatoid arthritis who had an inadequate response or intolerance to one or more ], filgotinib showed significance in treatment response compared with placebo.<ref>{{cite journal | vauthors = Genovese MC, Kalunian K, Gottenberg JE, Mozaffarian N, Bartok B, Matzkies F, Gao J, Guo Y, Tasset C, Sundy JS, de Vlam K, Walker D, Takeuchi T | title = Effect of Filgotinib vs Placebo on Clinical Response in Patients With Moderate to Severe Rheumatoid Arthritis Refractory to Disease-Modifying Antirheumatic Drug Therapy: The FINCH 2 Randomized Clinical Trial | journal = JAMA | volume = 322 | issue = 4 | pages = 315–325 | date = July 2019 | pmid = 31334793 | pmc = 6652745 | doi = 10.1001/jama.2019.9055 }}</ref>

==== MANTA ====
Due to concerns over testicular toxicity in males, the MANTA study is examining the safety of the drug in the context of treating ulcerative colitis.<ref>{{ClinicalTrialsGov|NCT03201445|Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Ulcerative Colitis}}</ref>{{Full citation needed|date=July 2020}} Despite these concerns, the FDA allowed a 200-mg daily dose for males in the Phase III FINCH trials.<ref>{{cite web|url=https://www.fiercebiotech.com/biotech/galapagos-gilead-include-high-dose-phiii-ra-trial-following-talk-fda|title=Galapagos, Gilead include high dose in PhIII RA trial after talk with FDA |website=FierceBiotech |access-date=8 January 2018}}</ref>

== References ==
{{Reflist}}

== External links ==
* {{commonscatinline}}
* {{ClinicalTrialsGov|NCT02889796|Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate (FINCH 1)}}
* {{ClinicalTrialsGov|NCT02873936|Filgotinib Versus Placebo in Adults With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Biologic Disease-modifying Anti-rheumatic Drug(s) (DMARDs) Treatment (FINCH 2)}}
* {{ClinicalTrialsGov|NCT02886728|Filgotinib Alone and in Combination With Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Are Naive to MTX Therapy (FINCH 3)}}
* {{ClinicalTrialsGov|NCT02914522|Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis (SELECTION1)}}
* {{ClinicalTrialsGov|NCT02914561|Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease (Diversity1)}}
* {{ClinicalTrialsGov|NCT04115748|Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Are Naive to Biologic DMARD Therapy (PENGUIN 1)}}
* {{ClinicalTrialsGov|NCT04115839|Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Have an Inadequate Response or Are Intolerant to Biologic DMARD Therapy (PENGUIN 2)}}

{{Immunosuppressants}}
{{Extracellular chemotherapeutic agents}}
{{Cytokine receptor modulators}}
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