{"id":157,"date":"2014-04-22T01:27:12","date_gmt":"2014-04-22T01:27:12","guid":{"rendered":"http:\/\/allphasepharma.com\/dir\/?p=157"},"modified":"2015-12-24T17:00:27","modified_gmt":"2015-12-24T22:00:27","slug":"antibiotics-with-qidp-designation","status":"publish","type":"post","link":"https:\/\/allphasepharma.com\/dir\/2014\/04\/22\/157\/antibiotics-with-qidp-designation\/","title":{"rendered":"Antibiotics with QIDP Designation – – – Updated 9-30-14"},"content":{"rendered":"

For the latest QIDP listing, please click HERE<\/a><\/strong><\/p>\n

\n

 <\/p>\n

Since\u00a0FDA issued the QIDP designation in 2012, many companies have requested this important ‘label’. \u00a0Which should not come as a surprise: QIDP status confers significant benefits – and there is no downside.<\/p>\n

While an official FDA list of drugs that have received QIDP “approval” does not seem to exist, several sources speak of approx. 30 compounds that have garnered this designation.\"FDA\"<\/a><\/p>\n

My quick Google search identified\u00a026 compounds. \u00a0While\u00a0most are from known antibiotic drug classes, they all have expanded spectra or PK\/PD benefits over existing drugs. Of interest, some compounds have changed hands or entered into co-development deals with large(r) Pharma companies.<\/p>\n

UPDATE 3<\/strong>: \u00a0 Dalbavancin (Dalvance), oritavancin (Orbactiv), and \u00a0tedizolid (Sivextro) were recently approved and are no longer listed here.<\/p>\n

NOTE<\/strong>: \u00a0 \u00a0Some drugs have transitioned from Phase 2 into Phase 3 since the table was first published 2 months ago.<\/p>\n

NOTE<\/strong>: \u00a0Please search this site\u00a0for other blogs related to QIDP; <\/span>
\nthe latest update is from 3\/28\/2015, with\u00a0a searchable table of all drugs<\/span><\/p>\n

The table below lists only systemic<\/span>\u00a0drugs in Phases 2 or 3 which garnered the QIDP designation. \u00a0MK-7655 (Relebactam) is the most recent addition to our list. Interestingly, there are no new antibiotic classes on the list; the group of FabI inhibitors (there are at least 3 in development) so far did not seek or has not received QIDP status.<\/p>\n

<\/p>\n

\n\n\n\n\t\n\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t
Drug Name<\/th>Company<\/th>Phase<\/th>Antibiotic Class<\/th>\n<\/tr>\n<\/thead>\n
Avarofloxacin<\/td>Actavis<\/td>Phase 2<\/td>quinolone<\/td>\n<\/tr>\n
Ceftazidime + avibactam<\/td>Actavis<\/td>Phase 3<\/td>B-lactam \/ BLI<\/td>\n<\/tr>\n
Ceftolozane + tazobactam<\/td>Cubist<\/td>Phase 3<\/td>B-lactam \/ BLI<\/td>\n<\/tr>\n
Delafloxacin<\/td>Melinta<\/td>Phase 3<\/td>quinolone<\/td>\n<\/tr>\n
Eravacycline<\/td>Tetraphase<\/td>Phase 3<\/td>tetracycline<\/td>\n<\/tr>\n
Finafloxacin<\/td>MerLion<\/td>Phase 2<\/td>quinolone<\/td>\n<\/tr>\n
Fusidic Acid<\/td>Cempra<\/td>Phase 2<\/td>fusidic acid<\/td>\n<\/tr>\n
Imipenem\/cilastatin + MK-7655<\/td>Merck<\/td>Phase 2<\/td>B-lactam \/ BLI<\/td>\n<\/tr>\n
Meropenem + RPX7009<\/td>The Medicines Comp (Rempex)<\/td>Phase 3<\/td>B-lactam \/ BLI<\/td>\n<\/tr>\n
Nemonoxacin<\/td>TaiGen Biotechnology<\/td>Phase 3<\/td>quinolone<\/td>\n<\/tr>\n
Omadacycline<\/td>Paratek<\/td>Phase 2<\/td>tetracycline<\/td>\n<\/tr>\n
Plazomicin<\/td>Achaogen<\/td>Phase 3<\/td>aminoglycoside<\/td>\n<\/tr>\n
Radezolid<\/td>Melinta<\/td>Phase 2<\/td>oxazolidinone<\/td>\n<\/tr>\n
Solithromycin<\/td>Cempra<\/td>Phase 3<\/td>macrolide \/ ketolide<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
\nCORRECTED: 9\/30\/\/2014<\/p>\n","protected":false},"excerpt":{"rendered":"

For the latest QIDP listing, please click HERE   Since\u00a0FDA issued the QIDP designation in 2012, many companies have requested this important ‘label’. \u00a0Which should not come as a surprise: QIDP status confers significant benefits – and there is no downside. While an official FDA list of drugs that have Continue reading Antibiotics with QIDP Designation – – – Updated 9-30-14<\/span>→<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":929,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[19,3],"tags":[22,463,288,345,344,66,85,236,20,465,425,578,5,469,467,21,464,433,234,67,170,579,466,462,468,7],"class_list":["post-157","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-qidp_antibiotic","category-the_news","tag-antibiotic-class","tag-carbavance","tag-ceftazidimeavibactam","tag-ceftolozane","tag-ceftolozanetazobactam","tag-dalbavancin","tag-dalvance","tag-delafloxacin","tag-development","tag-enfumafungin","tag-eravacycline","tag-fabi","tag-fda","tag-finafloxacin","tag-isovuconazole","tag-mode-of-action","tag-nvx-104","tag-omadacycline","tag-orbactiv","tag-oritavancin","tag-plazomicin","tag-relebactam","tag-scy-078","tag-sivextro","tag-solithromycin","tag-tedizolid"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/04\/FDA-GAIN-LPAD-banner-copy.jpg?fit=640%2C200&ssl=1","jetpack_shortlink":"https:\/\/wp.me\/p4KWFr-2x","jetpack_sharing_enabled":true,"jetpack-related-posts":[{"id":1408,"url":"https:\/\/allphasepharma.com\/dir\/2015\/05\/07\/1408\/no-such-thing-as-a-free-ride\/","url_meta":{"origin":157,"position":0},"title":"No Such Thing as a Free Ride\u2026","author":"Harald","date":"May 7, 2015","format":false,"excerpt":"..when it comes to FDA review of antibiotic NDAs.\u00a0 Some seem to have forgotten the dismal record of antibiotic approvals in the last 15 years, and the long list of failed submissions.\u00a0 Many failed not because of lack of efficacy or a bad safety profile but because of changes in\u2026","rel":"","context":"In "QIDP Antibiotics"","block_context":{"text":"QIDP Antibiotics","link":"https:\/\/allphasepharma.com\/dir\/category\/qidp_antibiotic\/"},"img":{"alt_text":"theBMJ","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/05\/theBMJ.jpg?resize=350%2C200","width":350,"height":200},"classes":[]},{"id":2911,"url":"https:\/\/allphasepharma.com\/dir\/2016\/11\/25\/2911\/prospecting-antibiotics\/","url_meta":{"origin":157,"position":1},"title":"Prospecting for New Antibiotics","author":"Harald","date":"November 25, 2016","format":false,"excerpt":"The QIDP designation was introduced in 2012 to incentivize drug development in antiinfectives. QIDP came with several attractive features, such as prolongation of patent life, FDA\u00a0expedited review and more.\u00a0 In addition, FDA made it quite easy to garner the label.\u00a0 As you can see, there is really no downside to\u2026","rel":"","context":"In "Did you know...?"","block_context":{"text":"Did you know...?","link":"https:\/\/allphasepharma.com\/dir\/category\/interesting_facts\/"},"img":{"alt_text":"engine-qidp-blog","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2016\/11\/Engine-QIDP-blog.jpg?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2016\/11\/Engine-QIDP-blog.jpg?resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2016\/11\/Engine-QIDP-blog.jpg?resize=525%2C300 1.5x"},"classes":[]},{"id":3211,"url":"https:\/\/allphasepharma.com\/dir\/2017\/03\/05\/3211\/qidp-liberal-hand-out-fda\/","url_meta":{"origin":157,"position":2},"title":"QIDP, a Liberal Hand-Out from FDA","author":"Harald","date":"March 5, 2017","format":false,"excerpt":"On our blog site, \u2018QIDP\u2019 stands for \u201cQualified Infectious Diseases Product\u201d but when you look up \u2018QIDP\u2019 on the internet, you will find that it also stands for \u201cQualified Intellectual Disabilities Professional\u201d. 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Our inofficial list has 61 drugs, of which we believe only 57 are still in active clinical development.\u00a0 So we are in fairly close agreement. That may seem like an impressive record but it is also\u2026","rel":"","context":"In "QIDP Antibiotics"","block_context":{"text":"QIDP Antibiotics","link":"https:\/\/allphasepharma.com\/dir\/category\/qidp_antibiotic\/"},"img":{"alt_text":"qidp-part2-slider","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2016\/10\/QIDP-Part2-slider.jpg?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2016\/10\/QIDP-Part2-slider.jpg?resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2016\/10\/QIDP-Part2-slider.jpg?resize=525%2C300 1.5x"},"classes":[]},{"id":1800,"url":"https:\/\/allphasepharma.com\/dir\/2015\/08\/01\/1800\/qidp-drugs-4th-edition\/","url_meta":{"origin":157,"position":4},"title":"QIDP Drugs – 4th Edition","author":"Harald","date":"August 1, 2015","format":false,"excerpt":">>> For the latest QIDP list, please click HERE \u00a0<<< Since our\u00a0last QIDP blog from April 8, 2015, several new drugs have made the list which now includes 41 compounds. Below a table\u00a0which includes compound, sponsor\u00a0and development stage (Phase). It also indicates whether a drug has been\u00a0the topic of a\u2026","rel":"","context":"In "Recent Literature"","block_context":{"text":"Recent Literature","link":"https:\/\/allphasepharma.com\/dir\/category\/recent_literature\/"},"img":{"alt_text":"QIDP 4th edition","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/08\/QIDP-4th-edition.jpg?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/08\/QIDP-4th-edition.jpg?resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/08\/QIDP-4th-edition.jpg?resize=525%2C300 1.5x"},"classes":[]},{"id":1332,"url":"https:\/\/allphasepharma.com\/dir\/2015\/03\/28\/1332\/drugs-with-qidp-designation-update-3282015\/","url_meta":{"origin":157,"position":5},"title":"Drugs with QIDP Designation \u2013 Update 4\/8\/2015","author":"Harald","date":"March 28, 2015","format":false,"excerpt":"For the latest QIDP listing, please click HERE Our latest internet search came up with 37 drugs that garnered QIDP status.\u00a0 They are listed in the Table below (if I missed a compound, please leave a comment!!). \u00a0The\u00a0table is searchable so you should be able to massage the data to\u2026","rel":"","context":"In "QIDP Antibiotics"","block_context":{"text":"QIDP Antibiotics","link":"https:\/\/allphasepharma.com\/dir\/category\/qidp_antibiotic\/"},"img":{"alt_text":"APPC + QIDP copy","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/10\/APPC-QIDP-copy.jpg?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/10\/APPC-QIDP-copy.jpg?resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/10\/APPC-QIDP-copy.jpg?resize=525%2C300 1.5x"},"classes":[]}],"jetpack_likes_enabled":true,"_links":{"self":[{"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/posts\/157","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/comments?post=157"}],"version-history":[{"count":38,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/posts\/157\/revisions"}],"predecessor-version":[{"id":2230,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/posts\/157\/revisions\/2230"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/media\/929"}],"wp:attachment":[{"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/media?parent=157"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/categories?post=157"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/tags?post=157"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}