| Status |
Code |
Definition |
| Discovery |
DR |
Compounds from their first synthesis through in vitro and in vivo
toxicology and pharmacology testing. |
| Clinical Unknown |
C? |
In clinical development, but the phase is unknown. |
| Phase I |
C1 |
Initial toxicity testing in healthy volunteers. An exception to this is for drugs that are intrinsically toxic at effective doses, such as cancer therapeutics, which go straight into subjects suffering from the target disease, as it is unethical to subject healthy volunteers to these effects. Such safety studies are often classified as phase I/II studies, and are referred to as such in the relevant drug summary where this distinction is made by the developing company. |
| Phase II |
C2 |
Small-scale testing in the target population, to assess therapeutic effects and to
establish dose levels for phase III trials. |
| Phase III |
C3 |
Large-scale trials in patients, usually at several centers, double-blind and randomized. Often compared to approved agents. |
| Pre-registration |
PR |
Drug trial data has been submitted to the regulatory authority for a particular country (eg the FDA in the United States or the EMEA in Europe), and the drug is awaiting approval for marketing. |
| Registered |
R |
The drug has been approved for marketing. There is sometimes a delay between registration
and launch, often because of difficulties in scaling-up the manufacturing process. In rare cases a drug may be approved
but not marketed. |
| Launched |
L |
Launched in a particular market and available for purchase. |
| Launched Extensively |
LX |
Launched in the US and at least two of the six other major pharmaceutical markets, namely Japan, United
Kingdom, France, Germany, Italy and Spain. |
| Research Tool |
RT |
A compound that is not in active development, but is commonly used in research as a standard. |
| Suspended |
S |
Suspended from active development for a time. This may be for financial reasons, strategic reasons,
or because of unexpected clinical events. A suspended drug may either go back into development, once problems are
rectified, or it may be dropped from the pipeline entirely. In contrast to Discontinued, this is a temporary phase, although of unspecified duration, and is considered semi-active. |
| Withdrawn |
W |
A drug that has been launched on the market, but has subsequently been withdrawn from sale. This
is usually due to reports of adverse effects or to manufacturing defects. |
| No Development Reported |
NDR |
No evidence of continuing development has been seen for at least 18 months, ie, there have been no journal publications, no mentions in company annual reports, press releases, etc. Also used in cases where a drug disappears from a company's published pipeline, in which case status will be changed immediately. |
| Discontinued |
DX |
Permanently dropped from active development. This status is only used if there is confirmation from a developing company. |
