A drug delivery device includes an outer body receiving a cartridge with a needle, a needle cap adapted to be coupled to the outer body and to cover the needle and a control mechanism for activating the drug delivery device. The control mechanism includes a control element received within the outer body and axially and/or rotationally movable relative to the outer body between an initial position, a first activating position, and a second activating position. The control element is coupled to the needle cap and to the cartridge, the needle cap is retained on the outer body when the control element is in the initial position, the needle cap is released from the outer body and the needle is covered by the outer body when the control element is in the first activating position, and the needle is exposed when the control element is in the second activating position.