Narcan, Suboxone(naloxone)
Kloxxado, Narcan, Nyxoid, Suboxone, Talwin, Targiniq, Zimhi, Zubsolv (naloxone) is a small molecule pharmaceutical. Naloxone was first approved as Narcan on 1982-01-01. It is used to treat opioid-related disorders, respiration disorders, and septic shock in the USA. It has been approved in Europe to treat opioid-related disorders. The pharmaceutical is active against delta-type opioid receptor and kappa-type opioid receptor. In addition, it is known to target mu-type opioid receptor.
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Commercial
Trade Name
FDA
EMA
Kloxxado, Narcan, Zimhi (generic drugs available since 1986-09-24, discontinued: Evzio)
CombinationsSuboxone, Zubsolv (generic drugs available since 1986-09-24, discontinued: Bunavail, Cassipa, Talwin, Targiniq)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Buprenorphine hydrochloride
+
Naloxone hydrochloride
Naloxone hydrochloride
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
ZIMHI | Adamis Pharmaceuticals | N-212854 RX | 2021-10-15 | 1 products, RLD, RS |
NALOXONE HYDROCHLORIDE | Amphastar Pharmaceuticals | N-208969 RX | 2023-03-07 | 1 products, RLD, RS |
NARCAN | Emergent BioDefense Operations Lansing | N-208411 OTC | 2015-11-18 | 1 products, RLD, RS |
KLOXXADO | Hikma Pharmaceuticals | N-212045 RX | 2021-04-29 | 1 products, RLD, RS |
NALOXONE HYDROCHLORIDE (AUTOINJECTOR) | Kaleo | N-215457 PEND | 2022-02-28 | 1 products, RLD |
Show 4 discontinued
Naloxone hydrochloride
+
Oxycodone hydrochloride
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
TARGINIQ | Purdue Pharma | N-205777 DISCN | 2014-07-23 | 3 products, RLD |
Hide discontinued
Naloxone hydrochloride
+
Pentazocine hydrochloride
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
TALWIN NX | Sanofi | N-018733 DISCN | 1982-12-16 | 1 products |
Hide discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
evzio(r) naloxone hcl | New Drug Application | 2020-02-23 |
kloxxado | New Drug Application | 2021-04-30 |
naloxone hydrochloride | ANDA | 2023-06-21 |
narcan | New Drug Application | 2020-11-01 |
suboxone | New Drug Application | 2021-03-17 |
targiniq | New Drug Application | 2016-12-22 |
zimhi | New Drug Application | 2021-10-28 |
zubsolv | New Drug Application | 2021-03-01 |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE, AMPHASTAR PHARMS INC | |||
2026-03-07 | NP |
Patent Expiration
Patent | Expires | Flag | FDA Information |
---|---|---|---|
Naloxone Hydrochloride, Zimhi, Adamis Pharms Corp | |||
11571518 | 2041-06-14 | DP | U-3515, U-3516, U-3517 |
11027072 | 2039-05-24 | DP | |
Buprenorphine Hydrochloride / Naloxone Hydrochloride, Bunavail, Bdsi | |||
9522188 | 2035-04-24 | DP | |
8703177 | 2032-08-20 | DP | |
8147866 | 2027-07-23 | DP | U-1521 |
9655843 | 2027-07-23 | DP | U-2017 |
Naloxone Hydrochloride, Evzio, Kaleo Inc | |||
10220158 | 2035-03-20 | DP | U-2500 |
9517307 | 2034-07-18 | DP | U-1925 |
8627816 | 2032-02-04 | DP | |
10143972 | 2031-05-24 | U-2476 | |
8939943 | 2031-02-28 | DP | |
9022022 | 2031-02-28 | DP | |
9474869 | 2031-02-28 | DP | U-1907 |
10322239 | 2031-02-28 | U-1907 | |
8021344 | 2029-11-02 | DP | |
8226610 | 2029-04-10 | DP | |
8231573 | 2028-11-25 | DP | |
7749194 | 2028-10-30 | DP | |
7947017 | 2028-03-12 | DP | |
9724471 | 2027-05-23 | DP | U-2092 |
8206360 | 2027-02-27 | DP | |
9238108 | 2027-02-20 | DP | |
11590286 | 2026-12-12 | DP | |
10960155 | 2026-06-25 | DP | |
7731686 | 2026-06-10 | DP | |
8926594 | 2026-03-31 | DP | |
9278182 | 2026-02-01 | DP | |
10335549 | 2025-04-30 | DP | |
8016788 | 2025-03-21 | DP | |
7731690 | 2025-01-15 | DP | |
7918823 | 2024-11-23 | DP | |
8313466 | 2024-11-23 | DP | |
8361029 | 2024-11-23 | DP | |
8425462 | 2024-11-23 | DP | |
8608698 | 2024-11-23 | DP | |
9056170 | 2024-11-23 | DP | |
9737669 | 2024-11-23 | DP | |
10314977 | 2024-11-23 | DP | |
10737028 | 2024-11-23 | DP | |
Naloxone Hydrochloride, Narcan, Emergent | |||
9480644 | 2035-03-16 | DP | U-1903 |
9707226 | 2035-03-16 | DP | U-1903 |
Naloxone Hydrochloride, Kloxxado, Hikma | |||
10722510 | 2034-08-26 | DP | U-3110 |
10973814 | 2034-08-26 | DP | U-3110 |
11135155 | 2034-08-26 | DP | |
11617713 | 2034-08-26 | DP | U-3110 |
11628139 | 2034-08-26 | DP | U-3110 |
Buprenorphine Hydrochloride / Naloxone Hydrochloride, Zubsolv, Orexo Us Inc | |||
8940330 | 2032-09-18 | DP | |
9259421 | 2032-09-18 | DP | |
9439900 | 2032-09-18 | DP | |
10874661 | 2032-09-18 | DP | |
10946010 | 2032-09-18 | DP | |
11020387 | 2032-09-18 | DP | U-3131 |
11020388 | 2032-09-18 | DP | U-3131 |
11433066 | 2032-09-18 | U-3131 | |
8470361 | 2030-05-22 | DP | U-1425 |
8658198 | 2027-12-03 | DP | U-1494 |
Naloxone Hydrochloride, Evzio (Autoinjector), Kaleo Inc | |||
10143792 | 2031-05-24 | U-2476 | |
Naloxone Hydrochloride, Naloxone Hydrochloride (Autoinjector), Kaleo Inc | |||
9814838 | 2031-02-28 | DP | |
Buprenorphine Hydrochloride / Naloxone Hydrochloride, Suboxone, Indivior Inc | |||
8475832 | 2030-03-26 | DP | U-1411 |
9687454 | 2029-08-07 | DP | U-1464 |
11135216 | 2029-08-07 | DP | U-3111 |
8603514 | 2024-04-03 | DP | U-1464 |
8017150 | 2023-02-13 | DP | |
Naloxone Hydrochloride / Oxycodone Hydrochloride, Targiniq, Purdue Pharma Lp | |||
9073933 | 2025-03-30 | DP | |
9522919 | 2025-03-30 | DS, DP | |
8846090 | 2023-04-04 | DP | |
8846091 | 2023-04-04 | DP | |
9555000 | 2023-04-04 | DP | U-1556 |
9907793 | 2023-04-04 | DP | U-1556 |
ATC Codes
A: Alimentary tract and metabolism drugs
— A06: Drugs for constipation
— A06A: Drugs for constipation
— A06AH: Peripheral opioid receptor antagonists
— A06AH04: Naloxone
N: Nervous system drugs
— N02: Analgesics
— N02A: Opioid analgesics
— N02AA: Natural opium alkaloid analgesics
— N02AA53: Hydromorphone and naloxone
— N02AA55: Oxycodone and naloxone
— N02AX: Other opioids in atc
— N02AX51: Tilidine and naloxone
V: Various drug classes in atc
— V03: All other therapeutic products
— V03A: All other therapeutic products
— V03AB: Antidotes
— V03AB15: Naloxone
HCPCS
Code | Description |
---|---|
G1028 | Take-home supply of nasal naloxone; 2-pack of 8mg per 0.1 ml nasal spray (provision of the services by a medicare-enrolled opioid treatment program); list separately in addition to code for primary procedure |
G2215 | Take-home supply of nasal naloxone; 2-pack of 4mg per 0.1 ml nasal spray (provision of the services by a medicare-enrolled opioid treatment program); list separately in addition to code for primary procedure |
G2216 | Take-home supply of injectable naloxone (provision of the services by a medicare-enrolled opioid treatment program); list separately in addition to code for primary procedure |
J0572 | Buprenorphine/naloxone, oral, less than or equal to 3 mg buprenorphine |
J0573 | Buprenorphine/naloxone, oral, greater than 3 mg, but less than or equal to 6 mg buprenorphine |
J0574 | Buprenorphine/naloxone, oral, greater than 6 mg, but less than or equal to 10 mg buprenorphine |
J0575 | Buprenorphine/naloxone, oral, greater than 10 mg buprenorphine |
J2310 | Injection, naloxone hydrochloride, per 1 mg |
Clinical
Clinical Trials
281 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Opioid-related disorders | D009293 | EFO_0005611 | F11 | 17 | 29 | 16 | 28 | 26 | 107 |
Pain | D010146 | EFO_0003843 | R52 | 8 | 6 | 6 | 4 | 4 | 27 |
Substance-related disorders | D019966 | EFO_0003890 | F13 | 1 | 2 | 2 | 6 | 4 | 15 |
Opiate overdose | D000083682 | 4 | 1 | — | 1 | 4 | 10 | ||
Drug overdose | D062787 | 5 | 2 | — | 1 | 2 | 9 | ||
Constipation | D003248 | HP_0002019 | K59.0 | — | 3 | 4 | 3 | — | 9 |
Chronic pain | D059350 | HP_0012532 | — | 2 | — | 3 | 3 | 8 | |
Postoperative pain | D010149 | G89.18 | — | — | — | 5 | 1 | 6 | |
Low back pain | D017116 | HP_0003419 | M54.5 | 1 | — | 3 | 2 | — | 6 |
Neoplasms | D009369 | C80 | — | 1 | 2 | 2 | 1 | 6 |
Show 23 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Heroin dependence | D006556 | EFO_0004240 | 2 | 1 | 4 | — | 1 | 7 | |
Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | 1 | — | 3 | 5 |
Pruritus | D011537 | HP_0000989 | L29 | — | 2 | 1 | — | 1 | 3 |
Substance withdrawal syndrome | D013375 | EFO_0005800 | — | — | 2 | — | — | 2 | |
Morphine dependence | D009021 | EFO_0005612 | — | — | 2 | — | — | 2 | |
Brain death | D001926 | G93.82 | 1 | 1 | 1 | — | — | 2 | |
Replacement arthroplasty knee | D019645 | — | — | 1 | — | — | 1 | ||
Spinal anesthesia | D000775 | — | — | 1 | — | — | 1 | ||
Hemiarthroplasty | D062785 | — | — | 1 | — | — | 1 | ||
Sezary syndrome | D012751 | C84.1 | — | — | 1 | — | — | 1 |
Show 6 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Healthy volunteers/patients | — | 7 | 3 | — | — | 3 | 13 | ||
Hyperalgesia | D006930 | 1 | 3 | — | — | — | 4 | ||
Placebos | D010919 | 1 | 2 | — | — | — | 2 | ||
Gambling | D005715 | F63.0 | — | 2 | — | — | — | 2 | |
Central nervous system sensitization | D059333 | — | 2 | — | — | — | 2 | ||
Hypogonadism | D007006 | E23.0 | 1 | 1 | — | — | — | 2 | |
Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | 2 | — | — | — | 2 |
Drug interactions | D004347 | 1 | 1 | — | — | — | 1 | ||
Inflammation | D007249 | — | 1 | — | — | — | 1 | ||
Irritable bowel syndrome | D043183 | EFO_0000555 | K58 | — | 1 | — | — | — | 1 |
Show 10 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Hepatitis c | D006526 | B19.2 | 2 | — | — | — | 2 | 4 | |
Hepacivirus | D016174 | 1 | — | — | — | — | 1 | ||
Cocaine-related disorders | D019970 | F14 | 1 | — | — | — | — | 1 | |
Pharmacokinetics | D010599 | 1 | — | — | — | — | 1 | ||
Dry eye syndromes | D015352 | H04.12 | 1 | — | — | — | — | 1 | |
Heart arrest | D006323 | EFO_0009492 | I46 | 1 | — | — | — | — | 1 |
Touch | D014110 | 1 | — | — | — | — | 1 | ||
Intestinal obstruction | D007415 | K56.60 | 1 | — | — | — | — | 1 | |
Biological availability | D001682 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Risk reduction behavior | D040242 | — | — | — | — | 2 | 2 | ||
Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | — | — | — | — | 2 | 2 |
Risk-taking | D012309 | — | — | — | — | 2 | 2 | ||
Postoperative nausea and vomiting | D020250 | EFO_0004888 | — | — | — | — | 2 | 2 | |
Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | — | — | — | 2 | 2 |
Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | — | — | 1 | 1 |
Addictive behavior | D016739 | EFO_0004347 | — | — | — | — | 1 | 1 | |
Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | — | — | — | 1 | 1 |
Harm reduction | D040261 | — | — | — | — | 1 | 1 | ||
Cancer pain | D000072716 | G89.3 | — | — | — | — | 1 | 1 |
Show 7 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | NALOXONE |
INN | naloxone |
Description | Naloxone is a synthetic morphinane alkaloid that is morphinone in which the enone double bond has been reduced to a single bond, the hydrogen at position 14 has been replaced by a hydroxy group, and the methyl group attached to the nitrogen has been replaced by an allyl group. A specific opioid antagonist, it is used (commonly as its hydrochloride salt) to reverse the effects of opioids, both following their use of opioids during surgery and in cases of known or suspected opioid overdose. It has a role as a mu-opioid receptor antagonist, a central nervous system depressant and an antidote to opioid poisoning. It is an organic heteropentacyclic compound, a morphinane alkaloid and a tertiary alcohol. It is a conjugate base of a naloxone(1+). It derives from a hydride of a morphinan. |
Classification | Small molecule |
Drug class | narcotic agonists/antagonists (normorphine type) |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | C=CCN1CC[C@]23c4c5ccc(O)c4O[C@H]2C(=O)CC[C@@]3(O)[C@H]1C5 |
Identifiers
PDB | — |
CAS-ID | 465-65-6 |
RxCUI | 7242 |
ChEMBL ID | CHEMBL80 |
ChEBI ID | 7459 |
PubChem CID | 5284596 |
DrugBank | DB01183 |
UNII ID | 36B82AMQ7N (ChemIDplus, GSRS) |
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Safety
Black-box Warning
Black-box warning for: Targiniq
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