Table 3.
Rectal formulations in clinical trials (Ref: clinicaltrials.gov).
| Drug | Dosage form | Indication | Status |
|---|---|---|---|
| Ceftriaxone | Suppository | Healthy | Phase I |
| Quetiapine | Suppository | Dementia, delirium | Phase I completed |
| Ibuprofen | Suppository | Healthy | Phase I completed |
| NRL001 | Suppository (slow release) | Incontinence | Phase I completed |
| Hydrocortisone | Suppository, enema | Healthy | Phase I completed |
| Nifedipine | Suppository | Chronic anal fissure | Phase I/II completed |
| Hydrocortisone | Suppository | Internal hemorrhoids | Phase II completed |
| Diclofenac | Suppository | Carcinoma prostate | Phase II completed |
| Meloxicam | Suppository | Ankylosing spondylitis | Phase III completed |
| Balsalazide | Suppository, enema | Ulcerative colitis | Phase III completed |
| Belladonna + opium | Suppository | Nephrolithiasis | Phase IV completed |
| Belladonna + opium | Suppository | Post-partum pain | Phase IV completed |
| Belladonna + opium | Suppository | Post-operative pain | Completed |
| Fluocortolone + lidocaine | Suppository, cream | Acute hemorrhoids | Not stated |
| Nil | Suppository, enema and rectal insert | HIV prevention | Not stated |
| Tenofovir | Enema | HIV prevention | Phase I |
| Fecal microbiota | Enema | Infection due to resistant organism | Phase I |
| Fecal microbiota | Enema | Crohn’s Disease | Phase I |
| Fecal microbiota | Enema | Acute pancreatitis | Phase I |
| Mesalamine | Enema | Healthy | Phase I completed |
| ALTH12 | Enema | Ulcerative colitis | Phase I completed |
| TF037 | Enema | Colonoscopy | Phase I completed |
| SB012 | Enema | Ulcerative colitis | Phase I/II completed |
| Fecal microbiota | Enema | Severe acute malnutrition | Phase I/II |
| Fecal microbiota | Enema | Clostridium difficile infection | Phase II |
| Fecal microbiota | Enema | Ulcerative colitis | Phase II completed |
| PUR0110 | Enema | Left-sided ulcerative colitis | Phase II completed |
| Manuka honey | Enema | Pouchitis | Phase II completed |
| Promelaxin | Enema | Chronic functional constipation | Phase IV |
| Chloral hydrate | Enema | Congenital cataract | Completed |
| NER1008 | Enema | Colorectal cancer | Completed |
| IQP-0528 | Rectal gel | HIV prevention | Phase I |
| Lidocaine | Rectal gel | Hemorrhoids | Phase I |
| Nil | Rectal gel (thermosensitive) | Ulcerative colitis | Phase I completed |
| Tenofovir | Rectal gel (mucoadhesive) | HIV prevention | Phase I completed |
| Tenofovir | Rectal gel (mucoadhesive) | HIV infection | Phase I completed |
| Dapivirine | Rectal gel | HIV infection | Phase I completed |
| PC-1005 | Rectal gel | HIV infections | Phase I completed |
| Maraviroc | Rectal gel | HIV/AIDS | Phase I completed |
| PP110 | Rectal gel | Bleeding hemorrhoids | Phase II/III completed |
| Lidocaine + diclofenac | Rectal gel | Anal fissure | Phase IV completed |
| Nil | Rectal gel (thermosensitive) | Healthy | Completed |