{"id":"oligog-dry-powder-for-inhalation","rwe":[],"tags":[],"phase":"discontinued","safety":{"boxedWarnings":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{"Pregnancy":"Data not available","Geriatric use":"Data not available","Paediatric use":"Data not available","Renal impairment":"Data not available","Hepatic impairment":"Data not available"},"seriousAdverseEvents":[]},"status":"discontinued","trials":["NCT03698448"],"aliases":["Placebo dry powder for inhalation"],"patents":[],"pricing":[],"offLabel":[],"timeline":[{"date":"2010","type":"positive","milestone":"Phase 2 clinical development initiated","regulator":"none","description":"AlgiPharma AS initiated Phase 2 trials of OligoG in cystic fibrosis patients"},{"date":"2012","type":"neutral","milestone":"Phase 2b randomized controlled trial completed","regulator":"none","description":"Phase 2b RCT in CF patients (N=65) completed; one parallel Phase 2b trial (N=15) terminated early"},{"date":"2013","type":"positive","milestone":"Burkholderia spp. infection study completed","regulator":"none","description":"Phase 2 study of OligoG in CF patients with Burkholderia spp. infection (N=15) completed"},{"date":"2014","type":"positive","milestone":"Lung deposition study completed","regulator":"none","description":"Radiolabeled OligoG lung deposition characterization study (N=10) sponsored by BDD Pharma Ltd completed"},{"date":"2018","type":"negative","milestone":"Program discontinued","regulator":"none","description":"AlgiPharma AS discontinued clinical development of OligoG; no regulatory approval achieved in any jurisdiction"}],"aiSummary":"OligoG Dry Powder for Inhalation is an investigational inhaled therapeutic developed by AlgiPharma AS for cystic fibrosis (CF), targeting the underlying pathophysiology of CF lung disease through a novel mechanism. The drug is composed of oligosaccharides derived from alginate and is designed to modulate biofilm formation and reduce bacterial adherence in the CF airway. Clinical development included four Phase 2 trials enrolling 105 patients total, with completed studies in CF populations including those with Burkholderia spp. infection and lung deposition characterization via radiolabeled formulation. The program has been discontinued, with no regulatory approvals achieved in any jurisdiction. The discontinuation reflects challenges in demonstrating clinical efficacy or commercial viability in the competitive CF therapeutic landscape, where approved agents like ivacaftor, lumacaftor, and tezacaftor dominate. No commercial revenue was generated, and the asset remains in the public domain without active development.","brandName":"OligoG Dry powder for inhalation","companyId":"algipharma-as","ecosystem":[],"mechanism":{"target":"Bacterial biofilm matrix and adhesion mechanisms in cystic fibrosis airways","novelty":"first-in-class","modality":"other","drugClass":"Anti-biofilm agent; inhaled oligosaccharide therapeutic","explanation":"OligoG is derived from alginate oligosaccharides and functions as a biofilm disruptor in the cystic fibrosis lung microenvironment. In CF, chronic bacterial infections—particularly Pseudomonas aeruginosa and Burkholderia species—form dense biofilms that are resistant to antibiotics and immune clearance, driving progressive lung damage. OligoG is hypothesized to interfere with biofilm matrix structure and bacterial adhesion mechanisms, potentially enhancing antibiotic penetration and immune recognition. By targeting the physical architecture of biofilms rather than bacterial viability directly, OligoG represents a mechanistically distinct approach to CF airway infection management, complementary to existing antimicrobial and CFTR modulator therapies.","oneSentence":"OligoG is an inhaled oligosaccharide that disrupts bacterial biofilm formation and reduces pathogenic adherence in cystic fibrosis airways.","technicalDetail":"OligoG comprises low-molecular-weight alginate oligosaccharides administered via dry powder inhalation to achieve direct lung deposition. The mechanism involves competitive inhibition of bacterial adhesins and disruption of extracellular polysaccharide matrix components, reducing biofilm stability without direct bactericidal activity. Lung deposition studies (Phase 2 radiolabeled trial, N=10) characterized pulmonary bioavailability and clearance kinetics. The drug class represents a novel anti-biofilm modality distinct from CFTR potentiators, aminoglycosides, or macrolide immunomodulators."},"commercial":{"notes":"Program discontinued; no commercial revenue generated. AlgiPharma AS is a private Norwegian biotech company with limited public financial disclosure.","yoyGrowth":"","launchDate":"","marketShare":"","revenueYear":"","annualCostUS":"","currentRevenue":"","percentOfCompany":"","patientPopulation":"~30,000 CF patients in US; ~100,000 globally","peakSalesEstimate":"","genericCompetition":"no"},"references":[],"biosimilars":[],"companyName":"AlgiPharma AS","competitors":[{"name":"Kalydeco (ivacaftor)","slug":"ivacaftor","company":"Vertex Pharmaceuticals","advantage":"FDA-approved CFTR potentiator; first-in-class; established clinical benefit in CF with G551D and other gating mutations"},{"name":"Orkambi (lumacaftor/ivacaftor)","slug":"lumacaftor-ivacaftor","company":"Vertex Pharmaceuticals","advantage":"FDA-approved CFTR corrector/potentiator combination; addresses F508del-CFTR, most common CF mutation"},{"name":"Symdeko (tezacaftor/ivacaftor)","slug":"tezacaftor-ivacaftor","company":"Vertex Pharmaceuticals","advantage":"FDA-approved next-generation CFTR corrector/potentiator; improved efficacy and tolerability vs. lumacaftor"},{"name":"Trikafta (elexacaftor/tezacaftor/ivacaftor)","slug":"elexacaftor-tezacaftor-ivacaftor","company":"Vertex Pharmaceuticals","advantage":"FDA-approved triple CFTR modulator; addresses ~90% of CF population; transformative clinical outcomes"},{"name":"TOBI Podhaler (tobramycin inhalation powder)","slug":"tobramycin-inhalation-powder","company":"Novartis","advantage":"FDA-approved inhaled aminoglycoside for chronic Pseudomonas aeruginosa infection in CF; established standard of care"}],"genericName":"OligoG Dry powder for inhalation","indications":{"approved":[],"offLabel":[],"pipeline":[{"name":"Cystic Fibrosis (general)","notes":"Phase 2b randomized placebo-controlled trial (N=65) completed; one Phase 2b trial terminated early (N=15)","phase":"Phase 2","status":"completed"},{"name":"Cystic Fibrosis with Burkholderia spp. Infection","notes":"Dedicated Phase 2 study (N=15) in CF patients with Burkholderia infection completed","phase":"Phase 2","status":"completed"},{"name":"Lung Deposition Characterization in Cystic Fibrosis","notes":"Radiolabeled OligoG lung deposition study (N=10) sponsored by BDD Pharma Ltd completed","phase":"Phase 2","status":"completed"}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT03822455","phase":"PHASE2","title":"A Phase 2b Randomised, Placebo Controlled Study of OligoG in Patients with Cystic Fibrosis","status":"TERMINATED","sponsor":"AlgiPharma AS","startDate":"2019-05-16","conditions":"Cystic Fibrosis","enrollment":15},{"nctId":"NCT03698448","phase":"PHASE2, PHASE3","title":"A Dose-finding Study of Inhaled OligoG vs Placebo in Patients With Cystic Fibrosis","status":"WITHDRAWN","sponsor":"AlgiPharma AS","startDate":"2021-09-01","conditions":"Cystic Fibrosis","enrollment":0},{"nctId":"NCT02453789","phase":"PHASE2","title":"A Study of OligoG in Cystic Fibrosis Subjects With Burkholderia Spp. Infection","status":"COMPLETED","sponsor":"AlgiPharma AS","startDate":"2015-02","conditions":"Cystic Fibrosis, Burkholderia Infection","enrollment":15},{"nctId":"NCT02157922","phase":"PHASE2","title":"A Phase IIb Study of OligoG in Subjects With Cystic Fibrosis","status":"COMPLETED","sponsor":"AlgiPharma AS","startDate":"2014-10","conditions":"Cystic Fibrosis","enrollment":65},{"nctId":"NCT01991028","phase":"PHASE2","title":"A Study to Investigate Lung Deposition of Radiolabelled OligoG","status":"COMPLETED","sponsor":"BDD Pharma Ltd","startDate":"2014-04","conditions":"Cystic Fibrosis","enrollment":10}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"🫁","route":"inhaled","frequency":"Data not available","formulation":"Dry powder for inhalation"},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[{"notes":"Norwegian private biotech company; no acquisition or licensing events disclosed","period":"2000–present","companyName":"AlgiPharma AS","relationship":"Originator"}],"therapeuticAreas":["Infectious Disease"],"trialPhaseCounts":{"PHASE2":4,"PHASE2, PHASE3":1},"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"Small molecule","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}