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Cubist Products & Pipeline

Marketed Products

Cubicin
Entereg

Strategic Partnership

Dificid

Pipeline Candidates

Product/Clinical Pipeline Portfolio

Product/Product Candidate Indication Phase 1Information Phase 2Information Phase 3Information MarketInformation
CUBICIN®
(daptomycin for injection) 		Certain Gram-positive infections including MRSA: cSSSI/SAB+      
ENTEREG®
(alvimopan) 		Accelerated GI motility
Bowel resection surgery with primary anastomosis		      
DIFICID®*
(Fidaxomicin) 		Clostridium difficile-associated diarrhea (CDAD)      
Ceftolozane/tazobactam
(CXA-201)
Certain infections caused by MDR Gram-negative pathogens including Pseudomonas aeruginosa. 		Complicated urinary tract infection (cUTI)***      
Complicated intra abdominal infection (cIAI)***      
Hospital-acquired/ventilator-associated bacterial pneumonia (HABP/VABP)***    
Surotomycin (CB-315)
(Oral novel lipopeptide) 		Clostridium difficile-associated diarrhea (CDAD)***      
Bevenopran (CB-5945)
(Novel mu-opioid receptor antagonist) 		Opioid-induced constipation
(OIC)***		      
AYX1 (Adynxx) Acute pain***      
+cSSSI = complicated skin & skin structure infections; SAB = staphylococcus aureus bacteremia.
* Agreement with Optimer Pharmaceuticals for Cubist to co-promote DIFICID in the U.S.
** Cubist has rights to AYX1 through its exclusive option to acquire Adynxx, Inc.
*** Potential indication sought, pending outcome of clinical trials

Information as of April 18, 2013.

Phase 1

Phase 1 includes the initial introduction of an investigational new drug into humans. Phase 1 studies are typically closely monitored and may be conducted in patients or normal volunteer subjects. These studies are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. During Phase 1, sufficient information about the drug's pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies. The total number of subjects and patients included in Phase 1 studies varies with the drug, but is generally in the range of 20 to 80. Phase 1 studies also include studies of drug metabolism, structure-activity relationships, and mechanism of action in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes.

Source: FDA’s 21 C.F.R. 312.21(b)

Phase 2

Phase 2 includes the controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. Phase 2 studies are typically well controlled, closely monitored, and conducted in a relatively small number of patients, usually involving no more than several hundred subjects.

Source: FDA’s 21 C.F.R. 312.21(b)

Phase 3

Phase 3 studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling. Phase 3 studies usually include from several hundred to several thousand subjects.

Source: FDA’s 21 C.F.R. 312.21(b)

Market

After completion of Phase 1 to 3 clinical trials, a Company may file for a New Drug Application (NDA), or a Biologic License Application (BLA) if the drug candidate is a vaccine or a recombinant protein. Upon review and final FDA approval for use in the specific disease indication, the Company can launch the drug into the marketplace.