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Pipeline
Company | Drug/Device | Medical Condition | Status |
---|---|---|---|
COVID-19 Trials and Actions | |||
eXIthera Pharmaceuticals | EP-7041 | thrombosis prevention in critically ill patients with COVID-19 | IND approved by the FDA for phase 2 trial |
Sorrento Therapeutics | intranasal STI-2099 (COVIDROPS) | mild COVID-19 | IND approved by the FDA |
Altimmune | AdCOVID | single-dose intranasal COVID-19 vaccine | commencement of patient enrollment in phase 1 trial |
AIVITA Biomedical | AV-COVID-19 | personalized COVID-19 vaccine | completion of phase 1 trial |
Novavax Takeda |
NVX-CoV2373 | COVID-19 vaccine | first patients dosed in phase 2 trial in Japan |
Johnson & Johnson | single-shot COVID-19 vaccine | COVID-19 | Emergency Use Authorization granted by the FDA |
Other Trials and Actions | |||
Flexion Therapeutics | FX301 | postoperative pain in patients undergoing bunionectomy | IND approved by the FDA |
Molecular Targeting Technologies | EBTATE (177Lu-DOTA-EB-TATE) | neuroendocrine tumors | IND approved by the FDA |
QureBio (no website available) | Q-1802 | advanced solid tumors | IND approved by the FDA |
TissueTech | TTBT01 | dry eye disease | IND approved by the FDA for phase 2 trial |
Hangzhou Sciwind Biosciences | XW003 | nonalcoholic steatohepatitis | IND approved by China’s National Medical Products Administration |
Wellmarker Bio | WM-S1-030 | advanced cancer | trial approved by the Australian Therapeutic Goods Administration |
Innovent | IBI322 | advanced malignancies | first patient dosed in phase 1a trial in the U. S |
Prometheus Biosciences | PRA023 | inflammatory bowel disease | first patients dosed in multiple ascending-dose (MAD) portion of phase 1a trial |
AbFero Pharmaceuticals | SP-420 | myelodysplastic and myelofibrosis patients with transfusional iron overload | initiation of phase 1 trial |
Apollomics | APL-106 (uproleselan injection) | relapsed or refractory acute myeloid leukemia | first patient enrolled in phase 1 trial in China |
Forendo Pharma | FOR-6219 | endometriosis | completion of phase 1 trials |
Kymera Therapeutics | KT-474 | atopic dermatitis or hidradenitis suppurativa | initiation of patient dosing in single ascending-dose (SAD) portion of phase 1 trial |
Pipeline Therapeutics | PIPE-307 | multiple sclerosis | initiation of phase 1 trial |
Clearside Biomedical | CLS-AX (axitinib injectable suspension) | neovascular age-related macular degeneration | completion of patient dosing in first cohort of phase 1/2a trial |
Cyclo Therapeutics | Trappsol Cyclo | Niemann-Pick disease type C1 | completion of last patient last visit in phase 1/2 trial |
Kronos Bio | KB-0742 | MYC gene-amplified solid tumors | first patient dosed in phase 1/2 trial |
Transgene BioInvent |
BT-001 | solid tumors | first patients enrolled in phase 1/2 trial |
Dicerna Roche |
RG6346 | chronic hepatitis B virus infection | initiation of phase 2 trial |
Highlight Therapeutics | BO-112 | patients with unresectable or metastatic melanoma that have previously progressed to checkpoint inhibitors | first patients enrolled in phase 2a trial |
Annexon | ANX007 | geographic atrophy | first patients dosed in phase 2 trial |
Assembly Biosciences Arbutus Biopharma |
vebicorvir in combination with AB-729 | chronic hepatitis B infection | initiation of phase 2 trial |
BioMarin Pharma | vosoritide | achondroplasia | patient enrollment complete in phase 2 trial |
BiomX | BX001 | mild-to-moderate acne | first patient dosed in phase 2 trial |
BioXcel Therapeutics | BXCL501 | delirium-related agitation | initiation of phase 2 trial |
Marker Therapeutics | MT-401 | patients with acute myeloid leukemia following an allogeneic stem-cell transplant in both the adjuvant and active disease settings | first patient treated in phase 2 trial |
Ocular Therapeutix | OTX-DED (dexamethasone intracanalicular ophthalmic insert) | short-term treatment for signs and symptoms of dry eye disease | first patient dosed in phase 2 trial |
Pharvaris | PHVS416 | hereditary angioedema due to C1-inhibitor deficiency type 1 and 2 | first patient dosed in phase 2 trial |
Longeveron | Lomecel-B infusion | aging frailty | completion of phase 2b trial |
Seres Therapeutics | SER-287 | mild-to-moderate ulcerative colitis | completion of patient enrollment in phase 2b trial |
ADial Therapeutics | AD04 | alcohol use disorder in persons with certain target genotype | 50 percent enrollment reached in phase 3 trial |
I-Mab | eftansomatropin alfa (TJ101) | pediatric growth hormone deficiency | first patient dosed in phase 3 trial in China |
Exicure | cavrotolimod (AST-008) | Merkel cell carcinoma | Orphan Drug designation granted by the FDA |
Oblato | OKN-007 | diffuse intrinsic Pontine glioma | Fast-Track designation granted by the FDA |
Anuncia | ReFlow System Mini | cerebrospinal fluid disorders requiring shunting | Breakthrough Device designation granted by the FDA |
MedAlliance | SELUTION SLR, sustained limus release DEB catheter | atherosclerotic lesions in native coronary arteries | Breakthrough Device designation granted by the FDA |
AbbVie | Humira (adalimumab) | moderate-to-severe active ulcerative colitis in children age 5 and older | approved by the FDA for expanded indication |
Bridge BioPharma Origin Biosciences |
Nulibry (fosdenopterin) for injection | molybdenum cofactor deficiency (MoCD) type A | approved by the FDA |
KemPharm | Azstarys (serdexmethylphenidate) | attention deficit hyperactivity disorder (ADHD) in patients age 6 and older | approved by the FDA |
Oncopeptides | Pepaxto (melphalan flufenamide | relapsed or refractory multiple myeloma | approved by the FDA |
Pfizer | Lorbrena (lorlatinib) | first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive nonsmall-cell lung cancer | approved by the FDA for expanded indication |
Sarepta Therapeutics | Amondys 45 (casimersen) | Duchenne muscular dystrophy patients with a confirmed mutation amenable to exon 45 skipping | approved by the FDA |
Accufix Surgical | Accu-Joint system | patients with degenerative and posttraumatic arthritis in the metatarsophalangeal joint | approved by the FDA |
Vascular Grafts Solutions | VIOLA device | clampless proximal anastomosis in coronary artery bypass grafting | approved by the FDA |
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