Today's TB drug regimen takes too long to administer and requires too many pills. The current treatment course, a product of the best scientific advances of the 1960s, consists of four medicines (known as first-line drugs): isoniazid, ethambutol, pyrazinamide and rifampin. This regimen works for active, drug-susceptible TB — as long as patients complete the six- to nine-month treatment. However, taken ideally under direct observation by a healthcare worker or community member, this treatment is burdensome for patients and care providers alike. Patients take an average of 130 doses. Those who do not or cannot complete their treatment may develop drug-resistant strains that take up to two years to treat with second-line drugs, which often cause severe side effects. Some resistant strains are untreatable with any existing antibiotics.

Further, the global HIV/AIDS pandemic is fueling an increase in TB, resulting in a dramatic rise in the number of co-infected individuals. An estimated one-third of the 40 million people living with HIV/AIDS worldwide are co-infected with TB. Unfortunately, the current TB drug regimen is not compatible with certain common antiretroviral (ARV) therapies used to treat HIV/AIDS, requiring a change in regimen to avoid drug-drug interactions.

In most endemic countries, US$20-40 will buy a full six-month drug course of TB treatments. Some national TB programs provide first-line drugs free to patients. But even where TB drugs are available to those in need, the length of treatment places an undue burden on patients. TB affects mainly the poor — those who can least afford frequent visits to health clinics, additional transportation costs, and lost work hours. Ninety-four percent of TB cases occur in the developing world, where health infrastructures are least equipped to diagnose the disease, handle the demand, and aid those who suffer.

In 1993, the World Health Organization (WHO) declared TB a global emergency, and the next year introduced a treatment plan to better fight the disease and control its spread. The plan works to enhance political commitment to TB control with increased and sustained financing; strives for improved detection through quality-assured diagnostic bacteriology; recommends standardized treatment with supervision and patient support; helps provide an effective drug supply and management system; and offers a worldwide monitoring and evaluation system with measurement of the impact of its comprehensive approach. Supervised treatment, called DOTS, or Directly Observed Treatment Short-Course, helps patients to take their drugs regularly and complete treatment.

In 2006, the WHO adopted the Stop TB strategy, building on and enhancing DOTS to dramatically reduce the global burden of TB by 2015, in line with the United Nations' Millennium Development Goals and the Stop TB Partnership targets. The Stop TB objectives include: achieving universal access to high-quality diagnosis and patient-centered treatment; reducing the human suffering and socioeconomic burden associated with TB; protecting poor and vulnerable populations from TB, TB/HIV, and drug-resistant TB; and supporting development of new tools, including new drugs, and help enable their timely and effective use.

The WHO's Stop TB programs are effective when patients adhere to their treatment and medicines are properly administered. However, the length and complexity of TB treatment continues to impose tremendous demands on local healthcare systems and on TB patients in treatment.

A faster, simpler cure for TB will save lives and have tremendous global benefits. A shorter TB regimen could improve treatment compliance (reducing the likelihood of drug-resistant strains emerging); broaden the reach of DOTS; and allow more patients to be treated. In 2006, DOTS programs reached 2.5 million new TB patients and cured 1.96 million worldwide. A shorter and simpler treatment will not only help cure those currently under care, but it will also allow health workers to reach more people by reducing the burden on national TB programs.

With the vast majority of TB patients concentrated in the world's poorest countries, there has traditionally been little incentive for the private sector to invest in the major research and development costs necessary for new TB medicines. Until recently, innovative research and development for TB drugs was at a virtual standstill, and had been since the 1960s. However, the early 21st century has seen a dramatic increase in TB activity. Today, multiple drug candidates are in clinical trials and thousands of potential compounds are being screened, synthesized, or optimized in discovery and preclinical studies. Much of this work is being done by the TB Alliance, which has the largest TB drug pipeline in the world, and its partners.