Pipeline Watchlist
Company Pipelines
Companies
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- Oxylanthanum CarbonateOLC / Renazorb / Phosphate / Small molecule / NephrologyHyperphosphatemia in chronic kidney disease (CKD) on dialysisNDAResubmittedUnited States
- UNI-494UNI-494 / KATP channel / Nitric oxide (nicorandil prodrug) / Small molecule / NephrologyAcute Kidney Injury (AKI)Phase 1CompletedUnited KingdomUnited StatesPrevention of Delayed Graft Function (DGF) in kidney transplant patientsPhase 1ActiveUnited States
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- EnobosarmVERU-024 / GTx-024 / Ostarine
- SabizabulinVERU-111
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- cantharidinVP-102 / YCANTH / Unknown / Small Molecule / DermatologyMolluscum ContagiosumApprovedActiveCommon WartsPhase 3ActiveExternal Genital WartsPhase 2Active
- VP-315VP-315 / Oncolytic peptide / Peptide / Dermatologic OncologyBasal Cell CarcinomaPhase 2ActiveSquamous Cell CarcinomaPhase 1/2Active
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- VAR 200Cholesterol Efflux Pathway (ABCA1 and ABCG1) / Cholesterol Efflux Mediator / Renal DiseasesFocal Segmental Glomerulosclerosis (FSGS)Phase 2activeUnited StatesDiabetic Kidney Disease (DKD)Phase 2activeUnited StatesAlport SyndromePreclinicalactiveUnited States
- IC 100Inflammasome ASC / Monoclonal Antibody / Inflammatory DiseasesCardiometabolic Conditions (Obesity-associated)PreclinicalactiveUnited StatesParkinson's DiseasePreclinicalactiveUnited StatesOrphan Renal DiseasesPreclinicalactiveUnited States
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- ObefazimodABX464 / microRNA-124 (miR-124) enhancer / Oral small molecule / Inflammatory diseasesModerately to severely active ulcerative colitisPhase 3ABTECT induction data readout completed July 2025; maintenance data expected Q2 2026Crohn's diseasePhase 2bENHANCE-CD initiated; 12-week induction data expected Q4 2026Moderately to severely active ulcerative colitis, combination therapyPreclinicalEvaluation of obefazimod combined with other agents; decision on combination agent expected in 2026
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- cytisiniclinenicotinic acetylcholine receptor / plant-derived alkaloid; partial agonist / nicotine dependencesmoking cessation in adultsNDA accepted; PDUFA June 20, 2026under FDA reviewUSe-cigarette or vaping cessationPhase 2 completed; Phase 3 design agreedBreakthrough Therapy designation; FDA CNPVUS
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- elraglusib9-ING-41 / GSK-3β / small molecule inhibitor / Oncology1L metastatic pancreatic cancer with gemcitabine/nab-paclitaxelPhase 2ongoing; Actuate-1801 Part 3BUSEUCanada1L metastatic pancreatic cancer with gemcitabine/nab-paclitaxelPhase 3in planning; registration trial contingent on funding1L metastatic pancreatic cancer with FOLFIRINOXPhase 2investigator-initiated; closed to enrollment
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- loncastuximab tesirine-lpylZYNLONTA / CD19 / antibody-drug conjugate / OncologyLOTIS-2 in 3L+ r/r DLBCLPhase 3/ConfirmatoryLOTIS-5 in r/r DLBCLPhase 3/ConfirmatoryLOTIS-7 in r/r B-NHLPhase 1b
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- ABP-450ABP-450 / Acetylcholine release / 900 kDa botulinum toxin type A complex; biosimilar biologic / Neurology; neuromuscular disordersEpisodic migrainePhase 2United StatesChronic migrainePhase 2United StatesCervical dystoniaPhase 2United States
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- Ampligenrintatolimod / Ampligen / TLR3 / dsRNA immuno-modulator / Oncology; immune disorders; viral diseasesMetastatic pancreatic ductal adenocarcinomaPhase 1b/2DURIPANCAdvanced, recurrent ovarian cancerPhase 2Refractory melanomaPhase 2
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- pemvidutideALT-801 / glucagon and GLP-1 receptors / balanced 1:1 glucagon/GLP-1 dual receptor agonist peptide / serious liver diseasesMetabolic dysfunction-associated steatohepatitis (MASH)Phase 3 plannedPERFORMA Phase 3 initiation planned 2H 2026; FDA Fast Track and Breakthrough Therapy DesignationsU.S.Alcohol use disorder (AUD)Phase 2RECLAIM Phase 2 enrollment complete; topline data expected 3Q 2026; FDA Fast Track DesignationU.S.Alcohol-associated liver disease (ALD)Phase 2RESTORE Phase 2 enrolling; enrollment completion expected 3Q 2026U.S.
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- (Z)-endoxifenestrogen receptor / oral small molecule SERM/D / Oncology; rare diseasesMetastatic breast cancerPhase 1/2FDA pathway discussions; IND study may proceed reportedUSAdjuvant breast cancerFDA pathway discussionsUSNeoadjuvant breast cancerongoing clinical studies: EVANGELINE and I-SPY2
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- belzupacap sarotalocanbel-sar; AU-011 / tumor-associated GAGs/HSPGs / virus-like drug conjugate (VDC) / oncologyearly-stage choroidal melanomaPhase 3ongoing CoMpass trialUSEuropemetastases to the choroidPhase 2ongoingUSEuropecancers of the ocular surfacePhase 1initiating proof-of-concept trialUSEurope
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- AbdakibartAVTX-009 / IL-1β / Humanized IgG4 monoclonal antibody / Immune-mediated inflammatory diseasesHidradenitis suppurativaPhase 2 completed; registrational Phase 3 plannedPositive topline Phase 2 LOTUS results reported May 5, 2026
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- ficerafusp alfaBCA101 / EGFR/TGF-β / bifunctional EGFR-directed monoclonal antibody bound to a human TGF-β ligand trap / Oncology1L recurrent/metastatic HPV-negative head and neck squamous cell carcinomaPhase 2/3ongoinggloballate-line MSS RAS wild-type metastatic colorectal cancerPhase 1/1benrolling expansion cohort
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- AMELUZ®AMELUZ® / aminolevulinic acid HCl topical gel; photodynamic therapy / DermatologyNew formulationMild to moderate actinic keratosis: face & scalp larger treatment area (3 tubes)Superficial basal cell carcinomaPhase 3database lockedUS
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- BB-301BB-301 / PABPN1 / AAV ddRNAi silence-and-replace genetic medicine / Rare disease; neuromuscularOculopharyngeal muscular dystrophy (OPMD)Phase 1b/2aClinical-stage
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- rese-celCABA-201 / CD19 / Autologous fully human 4-1BB CD19-CAR T cell therapy / Autoimmune diseaseDermatomyositisRegistrationalrecruitingUSAntisynthetase syndromeRegistrationalrecruitingUSImmune-mediated necrotizing myopathyPhase 1/2recruitingUS
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- gedatolisibPI3K/AKT/mTOR pathway; class I PI3K isoforms; mTORC1/2 / small molecule kinase inhibitor / OncologyHR+/HER2- advanced breast cancer, 2nd linePhase 3; NDA accepted/Priority Review for PIK3CA WTVIKTORIA-1 reported results; PDUFA July 17, 2026GlobalHR+/HER2- locally advanced or metastatic breast cancer, 1st linePhase 3VIKTORIA-2 ongoingNorth AmericaEuropeLatin AmericaAsiaMetastatic castration-resistant prostate cancerPhase 1/2CELC-G-201 ongoingUnited StatesEurope
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- Cretostimogene grenadenorepvecCG0070 / Intravesical oncolytic immunotherapy / Bladder cancerHigh-risk BCG-unresponsive NMIBC with CIS with or without high-grade Ta/T1 disease; monotherapy; BOND-003 Cohort CPhase 3Enrollment complete; data presented at AUA 2025High-risk BCG-unresponsive NMIBC with high-grade Ta/T1; monotherapy; BOND-003 Cohort PPhase 2Enrollment complete; topline results at SUO 2025Intermediate-risk NMIBC; monotherapy; PIVOT-006Phase 3Enrollment complete; topline data expected 1H 2026
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- RademikibartCBP-201 / IL-4Rα / human monoclonal antibody / Inflammatory diseasesAcute exacerbations of COPDPhase 2ongoingGlobalAcute exacerbations of asthmaPhase 2ongoingGlobalChronic asthmaongoing studies by SimcereChina
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- onvansertibPLK1 / oral small-molecule PLK1 inhibitor / Oncology1L RAS-mutated metastatic colorectal cancerPhase 2randomized CRDF-0042L KRAS-mutated metastatic colorectal cancerPhase 1b/2completed2L metastatic colorectal cancerPhase 3ONSEMBLE/CRDF-003 randomized
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- EDIT-401EDIT-401 / LDLR / in vivo CRISPR gene editing medicine / Cardiovascular diseasesHyperlipidemia / LDL-C reductionPreclinicalIND/CTA submission planned by mid-2026; human proof-of-concept targeted by end of 2026Atherosclerotic cardiovascular disease (ASCVD)PreclinicalIn developmentHeterozygous familial hypercholesterolemia (HeFH)PreclinicalFirst-in-human trial planned in 2026
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- FB102FB102 / CD122 / monoclonal antibody / Autoimmune and autoimmune-related diseasesCeliac diseasePhase 2Topline results expected in 2026; U.S. arm included after FDA IND approvalUnited StatesVitiligoPhase 1bTopline results expected in 1H 2026Alopecia areataPhase 1bData readout expected in 2026
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- PEDMARKPEDMARK / PEDMARQSI / cisplatin-induced ototoxicity / small molecule; sodium thiosulfate injection / oncology supportive careReduce risk of ototoxicity associated with cisplatin in pediatric patients 1 month and older with localized, non-metastatic solid tumorsApprovedMarketed; ongoing evidence generationUSEUUKCisplatin-induced ototoxicity in pediatric and AYA patients with non-metastatic solid tumorsPhase 2/3Positive topline results; pursuing registrationJapanOtoprotection in adults receiving cisplatin chemotherapy, including head and neck and testicular cancersPhase I/IIInvestigator-sponsored study initiatedUS
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- pociredirFTX-6058 / EED / PRC2; HbF induction / oral small molecule / HematologySickle cell diseasePhase 1bactive; potential registration-enabling trial planned for 2H 2026United States
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- imetelstatRYTELO / telomerase / telomerase inhibitor / Hematologic malignanciesJAK inhibitor relapsed/refractory myelofibrosisPhase 3open for screening and enrollmentfrontline myelofibrosis, intermediate-1/intermediate-2/high-risk; combination with ruxolitinibPhase 1open for screening and enrollmentrelapsed/refractory/intolerant acute myeloid leukemia or high-risk MDS after hypomethylating agentsPhase 2investigator-led; open for screening and enrollment
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- GLSI-100GP2 + GM-CSF / HER2/neu / peptide immunotherapy vaccine / OncologyPrevention of recurrence in HER2/neu-positive breast cancer after surgery and trastuzumab-based therapyPhase 3Ongoing; Fast Track designated; FLAMINGO-01United StatesEurope
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- Olvi-Vecolvimulogene nanivacirepvec / Oncolytic vaccinia virus immunotherapy / OncologyPlatinum-resistant/refractory ovarian cancer (PRROC)Phase 3Enrolling; topline data expected 2H 2026 (OnPrime/GOG-3076; NCT05281471)USNon-small cell lung cancer (NSCLC), advanced/metastatic recurrentPhase 2Dose-escalation ongoing (VIRO-25; NCT06463665); systemic IV Olvi-Vec + platinum-doublet + ICI vs docetaxelUSSmall cell lung cancer (SCLC), platinum-relapsed/refractoryPhase 1b/2Dose selection ongoing (OLVI-VEC-SCLC-202; NCT07136285); Olvi-Vec + platinum + etoposideChinaUS
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- NXC-201NXC-201 / BCMA / sterically-optimized autologous CAR-T / HematologyRelapsed/refractory AL AmyloidosisPhase 2BLA-enabling; enrollment completedUSIsraelSelect immune-mediated diseasesExpanding
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- TH103TH103 / VEGF / HSPG / Recombinant fusion protein / Retinal DiseasesNeovascular age-related macular degeneration (nAMD)Phase 1b/2OngoingDiabetic eye diseasePlannedPlannedRetinal vein occlusionPlannedPlanned
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- Lomecel-Blaromestrocel
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- LB-100LB-100 / Protein Phosphatase 2A (PP2A) / Small Molecule / OncologyOvarian Clear Cell CarcinomaPhase 2ActiveUnited StatesMetastatic Colon CancerPhase 1bActiveGlobalAdvanced Soft Tissue SarcomaPhase 1/2PausedEurope
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- nomlabofuspCTI-1601
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- SonelokimabM1095 / IL-17A and IL-17F (tri-specific Nanobody) / Nanobody (VHH) / Immunology (Dermatology and Rheumatology)Hidradenitis Suppurativa (HS)Phase 3OngoingGlobalAdolescent Hidradenitis Suppurativa (Teen HS)Phase 3OngoingGlobalPsoriatic Arthritis (PsA)Phase 3OngoingGlobal
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- lorundrostatMLS-101 / Aldosterone synthase (CYP11B2) / Small molecule / Cardio-Renal-Metabolic SyndromeUncontrolled and treatment-resistant hypertensionPhase 3CompletedGlobalObstructive Sleep Apnea (OSA) and HypertensionPhase 2OngoingGlobalChronic Kidney Disease (CKD)Phase 2OngoingGlobal
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- NBTXR3JNJ-1900 / Hensify / Tumor cell (Radioenhancer) / Functionalized hafnium oxide (HfO2) nanoparticles / OncologyLocally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC) - Platinum-ineligiblePhase 3OngoingGlobalRecurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)Phase 1/2OngoingGlobalSoft Tissue SarcomaApprovedMarketedEurope
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- NKX019NKX019 / CD19 / Allogeneic CAR-NK Cell Therapy / Autoimmune DiseasesLupus NephritisSystemic SclerosisInflammatory Myopathy
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- Tumor Treating FieldsTTFields / Optune Gio, Optune Lua, Optune Pax, Optune Mya / Mitotic spindle / Electric Field Therapy / OncologyGlioblastoma (GBM)ApprovedMarketedUnited StatesEuropeJapanGlioblastoma (GBM) - Earlier use (TRIDENT)Phase 3ActiveGlobalNon-Small Cell Lung Cancer (NSCLC)ApprovedMarketedUnited StatesJapanEurope
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- PALI-2108PALI-2108 / PDE4 / Small Molecule Prodrug / GastroenterologyUlcerative Colitis (UC)Phase 2ActiveGlobalCrohn's Disease (CD)Phase 2ActiveGlobal
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- DeucrictibantPHA121
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- RezatapoptPC14586
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- RilparencelREACT
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- NimacimabCB1 / Monoclonal antibody / Metabolic DiseasesObesityPhase 2activeUnited States
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- IvonescimabSMT112 / AK112
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- Epinephrine nasal sprayARS-1 / neffy / Alpha and beta-adrenergic receptors / Small Molecule / Immunology & AllergyType I Allergic Reactions (including Anaphylaxis)ApprovedActiveUnited StatesEuropean UnionCanadaUrticaria (Acute Flares of Chronic Spontaneous Urticaria)Phase 2ActiveUnited States