Clindamycin
Acanya, Cleocin, Clindagel, Clindesse, Duac, Evoclin, Onexton, Veltin, Xaciato, Ziana (clindamycin) is a small molecule pharmaceutical. Clindamycin was first approved as Cleocin hydrochloride on 1982-01-01. It is used to treat acne vulgaris, actinomycetales infections, bacterial infections, bacterial vaginosis, and bacteroides infections amongst others in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| respiratory tract diseases | D012140 |
| urogenital diseases | D000091642 |
| skin and connective tissue diseases | D017437 |
Trade Name
FDA
EMA
Cleocin, Clindagel, Clindesse, Evoclin, Xaciato (generic drugs available since 1986-04-07, discontinued: Cleocin)
CombinationsAcanya, Duac, Onexton, Veltin, Ziana (generic drugs available since 1986-04-07, discontinued: Benzaclin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Benzoyl peroxide
+
Clindamycin phosphate
Clindamycin hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CLEOCIN HYDROCHLORIDE | Mylan | N-050162 RX | 1982-01-01 | 3 products, RLD |
Clindamycin phosphate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% | APP Pharmaceuticals | N-050635 RX | 1989-12-22 | 1 products, RLD, RS |
| CLINDAGEL | Bausch Health Companies | N-050782 RX | 2000-11-27 | 1 products, RLD, RS |
| CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE | Baxter | N-208083 RX | 2017-04-20 | 3 products, RLD, RS |
| XACIATO | Dare Bioscience | N-215650 RX | 2021-12-07 | 1 products, RLD, RS |
| EVOCLIN | Mylan | N-050801 RX | 2004-10-22 | 1 products, RLD, RS |
| CLINDESSE | Padagis | N-050793 RX | 2004-11-30 | 1 products, RLD, RS |
| CLEOCIN PHOSPHATE | Mylan | N-050441 RX | 1982-01-01 | 1 products, RLD, RS |
| CLEOCIN T | Mylan | N-050600 RX | 1989-05-31 | 1 products, RLD, RS |
| CLEOCIN T | Mylan | N-050615 RX | 1987-01-07 | 1 products, RLD, RS |
| CLEOCIN | Mylan | N-050680 RX | 1998-03-02 | 1 products, RLD, RS |
Show 1 marketed
Show 6 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| acanya | New Drug Application | 2020-09-30 |
| benzaclin | New Drug Application | 2017-02-16 |
| cleocin phosphate | New Drug Application | 2023-06-13 |
| clindagel | New Drug Application | 2017-11-01 |
| clindesse | New Drug Application | 2021-02-01 |
| onexton | New Drug Application | 2020-04-06 |
| veltin | New Drug Application | 2021-08-01 |
| ziana | New Drug Application | 2017-03-01 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| acne vulgaris | EFO_0003894 | D000152 | L70 |
| actinomycetales infections | EFO_1001122 | D000193 | — |
| bacterial infections | — | D001424 | A49 |
| bacterial vaginosis | EFO_0003932 | D016585 | — |
| bacteroides infections | EFO_1000832 | D001442 | — |
| pneumocystis pneumonia | EFO_0007448 | D011020 | B59 |
| staphylococcal infections | — | D013203 | A49.01 |
| streptococcal infections | EFO_1001476 | D013290 | — |
| toxoplasmosis | EFO_0007517 | D014123 | B58 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
CLINDAMYCIN PHOSPHATE, XACIATO, DARE | |||
| 2029-12-07 | GAIN | ||
| 2024-12-07 | NP | ||
BENZOYL PEROXIDE / CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, ENCUBE | |||
| 2023-03-13 | CGT | ||
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE, AMNEAL | |||
| 2023-02-01 | CGT | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Clindamycin Phosphate, Xaciato, Dare | |||
| 11129896 | 2036-09-22 | U-3293 | |
| Benzoyl Peroxide / Clindamycin Phosphate, Acanya, Bausch | |||
| 8288434 | 2029-08-05 | DP | U-124, U-134, U-818, U-916, U-921, U-1033 |
| 8663699 | 2029-06-03 | U-124 | |
| 8895070 | 2029-06-03 | U-124 | |
| 9078870 | 2029-06-03 | DP | |
| 9504704 | 2029-06-03 | DP | U-124, U-134, U-818, U-916 |
| 9561208 | 2029-06-03 | DP | U-916 |
| 10137142 | 2029-06-03 | DP | U-916 |
| 10220049 | 2029-06-03 | DP | U-916 |
| 10624918 | 2029-06-03 | U-916 | |
| Clindamycin Phosphate, Clindesse, Padagis Us | |||
| 9789057 | 2026-12-02 | DP | U-137 |
| 6899890 | 2023-04-27 | DP | U-137 |
| Clindamycin Phosphate, Evoclin, Mylan | |||
| 7141237 | 2024-02-03 | DP | |
| 7374747 | 2024-01-23 | DP | U-921 |
ATC Codes
D: Dermatologicals
— D10: Anti-acne preparations
— D10A: Anti-acne preparations for topical use
— D10AF: Antiinfectives for treatment of acne
— D10AF01: Clindamycin
— D10AF51: Clindamycin, combinations
G: Genito urinary system and sex hormones
— G01: Gynecological antiinfectives and antiseptics
— G01A: Antiinfectives and antiseptics, excl. combinations with corticosteroids
— G01AA: Antibiotics, gynecological
— G01AA10: Clindamycin
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01F: Macrolides, lincosamides and streptogramins
— J01FF: Lincosamides
— J01FF01: Clindamycin
HCPCS
Code | Description |
|---|---|
| S0077 | Injection, clindamycin phosphate, 300 mg |
Clinical
Clinical Trials
166 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acne vulgaris | D000152 | EFO_0003894 | L70 | 12 | 3 | 15 | 25 | 4 | 57 |
| Bacterial vaginosis | D016585 | EFO_0003932 | — | 1 | 5 | 3 | 1 | 10 | |
| Staphylococcal infections | D013203 | A49.01 | — | 2 | 2 | 1 | 1 | 5 | |
| Wound infection | D014946 | — | — | — | 4 | — | 4 | ||
| Abscess | D000038 | EFO_0003030 | — | — | — | 1 | 2 | 3 | |
| Candidiasis | D002177 | B37 | — | — | 1 | 1 | — | 2 | |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | 2 | — | 2 |
| Open fractures | D005597 | — | — | — | 1 | — | 1 | ||
| Burns | D002056 | T30.0 | — | — | — | 1 | — | 1 | |
| Urinary bladder neoplasms | D001749 | C67 | — | — | — | 1 | — | 1 |
Show 11 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Malaria | D008288 | EFO_0001068 | B54 | — | 3 | 2 | — | — | 5 |
| Bacterial infections | D001424 | A49 | 2 | — | 1 | — | 1 | 4 | |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | 1 | — | 3 | 4 |
| Infections | D007239 | EFO_0000544 | 1 | 1 | 2 | — | — | 3 | |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | 1 | — | 1 | 2 |
| Vaginitis | D014627 | EFO_0005757 | N76 | 1 | — | 1 | — | — | 2 |
| Pneumocystis pneumonia | D011020 | EFO_0007448 | B59 | — | — | 1 | — | 1 | 2 |
| Covid-19 | D000086382 | U07.1 | — | 1 | 1 | — | — | 1 | |
| Nasal obstruction | D015508 | HP_0001742 | — | — | 1 | — | — | 1 | |
| Nasal surgical procedures | D059747 | — | — | 1 | — | — | 1 |
Show 22 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | — | 1 | — | — | — | 1 | ||
| Head and neck neoplasms | D006258 | — | 1 | — | — | — | 1 | ||
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | — | — | — | 1 | |
| Abdominal abscess | D018784 | EFO_1001753 | — | 1 | — | — | — | 1 | |
| Surgical wound infection | D013530 | — | 1 | — | — | — | 1 | ||
| Exanthema | D005076 | R21 | — | 1 | — | — | — | 1 | |
| Female infertility | D007247 | EFO_0008560 | N97 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 2 | — | — | — | — | 2 | ||
| Jaw fractures | D007572 | 1 | — | — | — | — | 1 | ||
| Endometriosis | D004715 | EFO_0001065 | N80 | 1 | — | — | — | — | 1 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Peritonsillar abscess | D000039 | EFO_0007429 | J36 | — | — | — | — | 2 | 2 |
| Cerebral toxoplasmosis | D016781 | EFO_0007200 | B58.2 | — | — | — | — | 2 | 2 |
| Inflammation | D007249 | — | — | — | — | 1 | 1 | ||
| Perioral dermatitis | D019557 | EFO_1001305 | L71.0 | — | — | — | — | 1 | 1 |
| Disease susceptibility | D004198 | — | — | — | — | 1 | 1 | ||
| Staphylococcus aureus | D013211 | NCBITaxon_1280 | — | — | — | — | 1 | 1 | |
| Orthodontic anchorage procedures | D052280 | — | — | — | — | 1 | 1 | ||
| Rectal fistula | D012003 | HP_0010447 | K60.3 | — | — | — | — | 1 | 1 |
| Bisphosphonate-associated osteonecrosis of the jaw | D059266 | — | — | — | — | 1 | 1 | ||
| Periapical diseases | D010483 | EFO_0010688 | — | — | — | — | 1 | 1 |
Show 7 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | CLINDAMYCIN |
| INN | clindamycin |
| Description | Clindamycin is a carbohydrate-containing antibiotic that is the semisynthetic derivative of lincomycin, a natural antibiotic. It has a role as a xenobiotic and an environmental contaminant. It is a carbohydrate-containing antibiotic, a S-glycosyl compound, a pyrrolidinecarboxamide, an organochlorine compound and a semisynthetic derivative. It is functionally related to a lincomycin. |
| Classification | Small molecule |
| Drug class | antibiotics (Streptomyces strain) |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CCC[C@@H]1C[C@@H](C(=O)N[C@H]([C@H](C)Cl)[C@H]2O[C@H](SC)[C@H](O)[C@@H](O)[C@H]2O)N(C)C1 |
Identifiers
| PDB | — |
| CAS-ID | 18323-44-9 |
| RxCUI | 2582 |
| ChEMBL ID | CHEMBL1753 |
| ChEBI ID | — |
| PubChem CID | 29029 |
| DrugBank | DB01190 |
| UNII ID | 3U02EL437C (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Cleocin - Pfizer
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Trends
PubMed Central
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Additional graphs summarizing 35,475 documents
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Safety
Black-box Warning
Black-box warning for: Cleocin phosphate
Adverse Events
Top Adverse Reactions
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1 adverse events reported
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