November 2023 Recap: Drug Pipeline Updates
The table below is a review of notable updates that occurred in November 2023 for investigational products in development (not an inclusive list).
| Drug | Pharmacologic Class | Proposed Indication | Status |
| Allergic Disorders | |||
| ADP101 (Alladapt) | Multi-allergen oral immunotherapy | Treatment of 1 or more of the most significant food allergens. | Fast Track designation |
| Dermatological Disorders | |||
| Prademagene zamikeracel (Abeona) | Autologous cell therapy | Treatment of recessive dystrophic epidermolysis bullosa. | BLA accepted for Priority Review |
| Roflumilast cream 0.15% (Arcutis) | Phosphodiesterase 4 inhibitor | Treatment of atopic dermatitis. | sNDA accepted for review |
| Gastrohepatic Disorders | |||
| CM-101 (Chemomab) | Monoclonal antibody designed to neutralize CCL24 | Treatment of primary sclerosing cholangitis. | Fast Track designation |
| Infectious Diseases | |||
| Zoliflodacin (Innoviva) | Spiropyrimidinetrione antimicrobial agent | Treatment for uncomplicated gonorrhea. | Phase 3 results |
| Neurologic Disorders | |||
| AVB-101 (AviadoBio) | Gene therapy designed to restore progranulin levels | Treatment of frontotemporal dementia with mutations in the progranulin gene. | Fast Track designation |
| Xanomeline-trospium (KarXT; Karuna) | Muscarinic agonist and a muscarinic antagonist. | Treatment of schizophrenia in adults. | NDA accepted |
| SPN-830 (Supernus) | Non-ergoline dopamine agonist | Continuous subcutaneous infusion of apomorphine for treatment of motor fluctuations (off episodes) in adults with Parkinson disease. | Resubmitted NDA accepted for review |
| Oncology | |||
| Aliqopa (Bayer) | Kinase inhibitor | Treatment of adults with relapsed follicular lymphoma who have received at least 2 prior systemic therapies. | NDA withdrawn |
| Pembrolizumab plus enfortumab vedotin (Merck) | Programmed death receptor-1 blocking antibody and microtubule inhibitor conjugate | Treatment of patients with locally advanced or metastatic urothelial cancer. | sBLA accepted for Priority Review |
| Lisocabtagene maraleucel (Bristol Myers Squibb) | CD19-directed genetically modified autologous T cell immunotherapy | Treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who received a prior Bruton tyrosine kinase inhibitor and B-cell lymphoma 2 inhibitor . | Priority Review |
| THIO (MAIA Biotechnology) | Modified nucleotide 6-thio-2’-deoxyguanosine | Treatment of glioblastoma. | Orphan Drug status |
| Ophthalmology | |||
| Reproxalap (Aldeyra) | Small-molecule modulator of reactive aldehyde species | Treatment of dry eye disease. | Complete Response Letter issued |
| Poisoning and Drug Dependence | |||
| OX124 (Orexo) | Naloxone | Treatment of opioid overdose. | NDA under review |
