This chapter deals with the approved and marketed anticancer drugs derived
from marine sponges, mollusks/cyanobacteria, and tunicates; marine biota-derived
anticancer compounds in clinical trials i.e in III, II, and I phases; and bioactive new
chemical entities (NCEs) with anticancer function from marine biota. Limiting factors
in the development and approval of drugs from marine biota and significant challenges
in the development and approval of marine drugs are also given.
Keywords: Challenges in drug development, Clinical trials, Marine anticancer drugs, New chemical entities, Limiting factors.