Nektar | R&D Pipeline | Products in Development

Clinical Trials

Learn about Nektar's ongoing clinical trials for products in development

Approved Products

Nektar technologies have enabled top-selling commercial drugs through partnerships with leading biopharmaceutical companies

Platform Technologies

Latest Headlines

See the most recent news on Nektar programs in development

Nektar also has a number of strategic partnerships ranging from joint discovery and co-development to licensing and royalty arrangements with numerous companies.

Products by Therapeutic Area Nektar
Discovered Indication Phase view all Partner

Preclinical:

An exploratory phase, which gathers preliminary data on the agent's pharmacokinetics (how the body processes the drug) and pharmacodynamics (how the drug works in the body).

Phase 1:

A clinical trial that normally tests a new treatment in a small number of healthy patient volunteers in order to evaluate its safety, determine an appropriate dosage range and identify any side effects.

Phase 2:

A clinical trial that usually tests a new treatment in a small number of patients who have the illness that the drug is designed to treat. Phase 2 trials measure the drugs effectiveness as well as safety.

Phase 3:

A clinical trial that definitively tests a new treatment, usually in a large number of patients who have the illness that the drug is designed to treat. Phase 3 trials confirm a drug's effectiveness, monitors side effects, and confirms its safety as compared to the standard of care.

Filed:

In the final phase, a Non-Disclosure Agreement is filed with the FDA, who will then validate the claim and approve the drug to be marketed to the public. This phase includes post-marketing studies to outline the drug's risks, benefits, and optimal use.

Oncology

NKTR-102 Metastatic Breast Cancer
Phase 3

CNS

NKTR-118 Opioid-induced constipation (OIC)
Phase 3 AstraZeneca

Immunology /Inflammation

Cimzia® Psoriatic Arthritis
Ankylosing Spondylitis
Phase 3 UCB Pharma

Other Licensing Partnerships

LEVADEX™ Migraine
Phase 3 MAP Pharmaceuticals

Peginesatide
a product under development by Takeda and Affymax Renal Anemia
Phase 3 Affymax

* LEVADEX™ is a trademark and TEMPO® is a registered trademark of MAP Pharmaceuticals; Cimzia® is a registered trademark of UCB.

BAX 855 (pegylated rFVIII molecule)

BAX 855 is a PEGylated recombinant FVIII molecule, which utilizes Nektar's proprietary PEGylation technology and Baxter's proprietary plasma and albumin free platform. The program is Baxter's most advanced longer-acting candidate, and is in Phase 1 clinical development. A Phase 3 program is expected to be started by Baxter before the end of 2012.
BAX 855 is based upon Baxter's ADVATE, the world's leading rFVIII therapy. Preclinical animal study data demonstrate that one injection per week of BAX 855 leads to similar FVIII levels as three injections of ADVATE given approximately every other day.

Longer-acting therapeutic clotting proteins

Nektar and Baxter have multiple partnerships in hemophilia. Under the terms of these collaborations, Nektar is entitled to receive royalties on the global sales of long-acting clotting protein programs for hemophilia that use Nektar's PEGylation and advanced polymer conjugate technologies. Nektar is also entitled to contract research and manufacturing revenues for these programs. Nektar's innovative releasable linker conjugate technology is used in the development of these therapeutics.

LEVADEX™

Under the terms of a license agreement between Nektar and MAP Pharmaceuticals, Nektar is entitled to receive royalties on the global sales of LEVADEX™ for all indications. LEVADEX is an orally inhaled version of dihydroergotamine (DHE), self-administered via MAP's proprietary TEMPO® inhaler. DHE is available as an intravenous therapy which has been used in clinical settings for over 50 years to safely treat migraine. A New Drug Application (NDA) for LEVADEX is currently being reviewed by the U.S. Food and Drug Administration (FDA) and the PDUFA is March 26, 2012.

Cipro Inhale

Under development by Bayer Healthcare, inhaled cipro is a targeted inhaled antibiotic therapy for pulmonary infections in cystic fibrosis patients. It is a specially formulated form of ciprofloxacin betaine that is delivered via dry powder inhalation to the target area of the lung. The investigational product candidate is currently in Phase 2 clinical trials in patients and features a small, hand-held inhaler for ease-of-use. Nektar is entitled to royalties on sales of Cipro Inhale upon commercialization.

NKTR-061

Invented by Nektar, Partnered with Bayer

Preparing for Phase 3 Pivotal Trials

Aerosolized antibiotic in both on and off ventilator setting

Amikacin Inhale combines a novel, preservative-free liquid formulation of antibiotic amikacin with a Liquid Pulmonary Technology (LPT™) originally developed by Nektar. The product is under development to treat Gram-negative pneumonias.

Oral NKTR-118

Internally discovered by Nektar

In Phase 3 Studies

Oral NKTR-118 is a novel peripheral opioid antagonist created using Nektar's advanced polymer conjugate technology.

Oral NKTR-119 (Oral NKTR-118 and opioid co-formulation product)

Invented by Nektar

Currently in research/preclinical

Oral NKTR-119 is an investigational drug candidate that is a co-formulation of Oral NKTR-118 and an opioid analgesic. The product is in preclinical stages for the treatment of pain without the gastrointestinal side effects associated with traditional opioid therapies.

NKTR-181

Invented by Nektar

Completed Phase 1 development and is being prepared for a Phase 2 study

NKTR-181 is a new oral opioid analgesic candidate in development for the treatment of chronic pain. It is designed to address the abuse liability and serious central nervous system (CNS) side effects associated with current opioid therapies. NKTR-181 is a novel mu-opioid agonist created using Nektar's proprietary polymer conjugate technology and its differentiating properties are inherent to the design of its new molecular structure.

NKTR-171

Invented by Nektar

Currently in research/preclinical

NKTR-171 is a drug candidate designed to treat neuropathic pain without the CNS side effects. The product was developed using Nektar's advanced polymer conjugate technology and is in early research.

NKTR-192

Invented by Nektar

Currently in Preclinical Studies

NKTR-192 is Nektar Therapeutics' product candidate for the treatment of moderate to severe acute pain. NKTR-192 is a novel mu-opioid analgesic created using Nektar's advanced polymer conjugation technology to slow drug entry into the central nervous system (CNS). By dramatically slowing the rate of drug entry into the CNS, NKTR-192 is intended to maintain opioid-like efficacy without the abuse potential associated with rapid-acting opioids.

Cimzia®

Nektar technology is used in the antibody fragment, Cimzia® (certolizumab pegol). Cimzia is the first and only PEGylated Fab' fragment of a humanized anti-TNF-alpha antibody approved by the FDA for Crohn's disease. This product is approved in the U.S. and filed in the EU for rheumatoid arthritis and in phase 3 for ankylosing spondylitis and psoriatic arthritis. Under the terms of the agreement between Nektar and UCB, Nektar will receive manufacturing revenues and royalties on global sales for all indications.

NKTR-125

Invented by Nektar

Currently in research

Anti-histamine without CNS side effects

Combines Nektar Advanced Polymer Conjugate Technology™ with a potent anti-histamine to enhance its anti-inflammatory properties and minimize the undesirable side effects.

NKTR-140

Internally discovered by Nektar

Preparing for Phase 1 studies

Novel protease inhibitor for HIV

NKTR-140 is a novel protease inhibitor created using Nektar's advanced polymer conjugate technology and is designed to have improved potency and eliminate the need for a co-administered protease inhibitor booster, such as ritonavir. NKTR-140 is in preclinical development and is expected to enter Phase 1 studies in Q4 2009.

NKTR-102

Internally discovered by Nektar

Currently in Phase 3 clinical trials in metastatic breast cancer

Novel pro-drug topoisomerase I inhibitor

NKTR-102 is a topoisomerase I inhibitor-polymer conjugate with a unique pharmacokinetics profile that provides a continuous concentration of active drug with reduced peak concentrations. NKTR-102 was invented by Nektar using its advanced polymer conjugate technology platform, and is the first oncology product candidate to leverage Nektar's releasable polymer technology platform.

NKTR-102

Internally discovered by Nektar

Currently in Phase 2 clinical trials in platinum-resistant ovarian cancer

NKTR-102

Internally discovered by Nektar

Currently in Phase 2 clinical trials in second-line colorectal cancer

NKTR-102

Internally discovered by Nektar

Currently in Phase 1 clinical trials in multiple tumor settings

Peginesatide (formerly called Hematide™)

Nektar's proprietary conjugation technology is used in the novel peptide mimetic, peginesatide. The therapeutic is a synthetic, peptide-based erythropoiesis-stimulating agent under development by Takeda and Affymax. Under the terms of an exclusive agreement between Nektar and Affymax, Nektar is entitled to receive royalties on the global sales of peginesatide for all indications, as well as manufacturing revenues. A New Drug Application (NDA) for peginesatide for the treatment of anemia associated with CKD in adult patients on dialysis is currently being reviewed by the U.S. Food and Drug Administration (FDA) and the PDUFA is March 27, 2012.

CDP791

Nektar technology is used in the antibody fragment, CDP791. The product is in Phase 2 clinical trials for non-small cell lung cancer. Under the terms of the agreement between Nektar and UCB, Nektar will receive manufacturing revenues and royalties on global sales of CDP791 for all indications.

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